Trial Outcomes & Findings for Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients (NCT NCT03040024)

Last Updated: 2021-07-08

Results Overview

The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

71 participants

Primary outcome timeframe

Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)

Results posted on

2021-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine 0.5 mg/kg Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Overall Study STARTED	21	26	24
Overall Study COMPLETED	21	24	23
Overall Study NOT COMPLETED	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine 1.0 mg/kg Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Overall Study Adverse Event	1	0
Overall Study Death	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine 0.5 mg/kg n=21 Participants Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=26 Participants Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=24 Participants Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Total n=71 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 8.6 • n=93 Participants	64.6 years STANDARD_DEVIATION 12.4 • n=4 Participants	64.5 years STANDARD_DEVIATION 11.5 • n=27 Participants	64.3 years STANDARD_DEVIATION 10.9 • n=483 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	25 Participants n=483 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	18 Participants n=4 Participants	16 Participants n=27 Participants	46 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=93 Participants	26 Participants n=4 Participants	24 Participants n=27 Participants	70 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	10 Participants n=483 Participants
Race (NIH/OMB) White	18 Participants n=93 Participants	21 Participants n=4 Participants	20 Participants n=27 Participants	59 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Region of Enrollment United States	21 participants n=93 Participants	26 participants n=4 Participants	24 participants n=27 Participants	71 participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)

Population: Unable to collect data in 15 participants. N=12: Provider not available. N=2 No PACU. N=1 Physician Decision (withdrawal)

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=17 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=22 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=17 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score Delirium CAM-ICU Score at PACU Arrival	11 Participants	9 Participants	9 Participants
Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score No Delirium CAM-ICU Score at PACU Discharge	11 Participants	17 Participants	15 Participants
Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score No Delirium CAM-ICU Score at PACU Arrival	6 Participants	13 Participants	10 Participants
Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score Delirium CAM-ICU Score at PACU Discharge	6 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Post Operation (Up to 6 Hours), Post Operation Day 0

Population: Unable to collect information for this outcome. The investigators collected the pain scales from the EMR. The BPS was not routinely collected in the hospital and they only report Visual analog scale (VAS).

The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks)

Scores range from 0 (no pain) to 10 (worst pain).

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=21 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=26 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=24 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score Baseline Pain Level assessed by the Visual Analog Scale (VAS) Score	3.50 units on a scale Standard Deviation 3.25	4.36 units on a scale Standard Deviation 2.94	2.30 units on a scale Standard Deviation 2.88
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (PACU)	1.00 units on a scale Standard Deviation 2.45	2.56 units on a scale Standard Deviation 3.28	1.63 units on a scale Standard Deviation 3.11
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 0)	4.76 units on a scale Standard Deviation 3.86	4.22 units on a scale Standard Deviation 3.24	3.62 units on a scale Standard Deviation 3.74
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 1)	3.93 units on a scale Standard Deviation 2.76	3.72 units on a scale Standard Deviation 2.55	3.52 units on a scale Standard Deviation 2.42
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 2)	2.47 units on a scale Standard Deviation 2.52	2.81 units on a scale Standard Deviation 2.51	3.38 units on a scale Standard Deviation 2.62
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 3)	3.08 units on a scale Standard Deviation 2.94	3.35 units on a scale Standard Deviation 2.15	3.41 units on a scale Standard Deviation 2.20
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score Pain Level assessed by the Visual Analog Scale Score Post surgery (follow up visit - Up to 6 weeks)	2.3 units on a scale Standard Deviation 2.58	3.09 units on a scale Standard Deviation 2.68	3.00 units on a scale Standard Deviation 2.60

SECONDARY outcome

Timeframe: Baseline, Post Surgery (Up to 6 Weeks)

Population: The number of participants is different from participant flow because some of the subjects did not complete the assessment.

The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia.

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=20 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=25 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=24 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Change in Mini Cog Score Baseline Mini Cog Score- Positive Screen	2 Participants	5 Participants	6 Participants
Change in Mini Cog Score Baseline Mini Cog Score- Negative Screen	18 Participants	20 Participants	18 Participants
Change in Mini Cog Score Mini Cog Score Post surgery (Up to 6 weeks) - Positive Screen	3 Participants	0 Participants	3 Participants
Change in Mini Cog Score Mini Cog Score Post surgery (Up to 6 weeks) - Negative Screen	17 Participants	23 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline, Post Surgery (Up to 6 Weeks)

Population: This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed.

The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment.

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=20 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=25 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=24 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Change in Mini-Mental Status Examination (MMSE) Score Normal Baseline MMSE Score (25-30)	18 Participants	22 Participants	22 Participants
Change in Mini-Mental Status Examination (MMSE) Score Cognitive Impairment Baseline MMSE Score (0-24)	2 Participants	3 Participants	2 Participants
Change in Mini-Mental Status Examination (MMSE) Score Normal Post surgery (Up to 6 weeks) MMSE Score (25-30)	17 Participants	23 Participants	16 Participants
Change in Mini-Mental Status Examination (MMSE) Score Cognitive Impairment Post surgery (Up to 6 weeks) MMSE Score (0-24)	3 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Post Surgery (Up to 6 Weeks)

Population: This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed.

The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention.

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=20 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=25 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=24 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Change in Cognitive Failure Questionnaire (CFQ) Score Baseline CFQ Score	27 score on a scale Interval 21.0 to 38.0	34 score on a scale Interval 22.0 to 40.0	30 score on a scale Interval 21.5 to 38.5
Change in Cognitive Failure Questionnaire (CFQ) Score CFQ Score Post surgery (Up to 6 weeks)	29 score on a scale Interval 23.0 to 35.0	30 score on a scale Interval 15.0 to 40.0	29 score on a scale Interval 23.0 to 37.0

SECONDARY outcome

Timeframe: Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention)

Population: The population is different at 6 weeks post intervention because this outcome was not completed for some participants at that time point.

The total amount of narcotics used measured in morphine milligram equivalents (MME).

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=21 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=26 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=24 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Post Operative Narcotics Use Post Intervention (Intraoperative)	13.3 morphine milligram equivalents (MME) Interval 6.7 to 13.33	13.3 morphine milligram equivalents (MME) Interval 10.0 to 20.0	13.33 morphine milligram equivalents (MME) Interval 8.75 to 16.0
Post Operative Narcotics Use Post Intervention (POD 0)	7.1 morphine milligram equivalents (MME) Interval 0.0 to 11.9	6.67 morphine milligram equivalents (MME) Interval 0.0 to 11.9	6.18 morphine milligram equivalents (MME) Interval 3.3 to 15.1
Post Operative Narcotics Use Post Intervention (POD 1)	35 morphine milligram equivalents (MME) Interval 10.7 to 57.7	41.5 morphine milligram equivalents (MME) Interval 27.1 to 91.4	42.9 morphine milligram equivalents (MME) Interval 25.7 to 51.4
Post Operative Narcotics Use Post Intervention (POD 2)	8.59 morphine milligram equivalents (MME) Interval 2.0 to 53.8	25.7 morphine milligram equivalents (MME) Interval 10.0 to 78.6	41.9 morphine milligram equivalents (MME) Interval 17.3 to 51.4
Post Operative Narcotics Use Post Intervention (POD 3)	19.8 morphine milligram equivalents (MME) Interval 0.0 to 40.8	34.3 morphine milligram equivalents (MME) Interval 2.0 to 50.7	34.3 morphine milligram equivalents (MME) Interval 17.1 to 44.9
Post Operative Narcotics Use Post Intervention (Follow up visit-up to 6 weeks)	0 morphine milligram equivalents (MME) Interval 0.0 to 8.6	0 morphine milligram equivalents (MME) Interval 0.0 to 38.4	0 morphine milligram equivalents (MME) Interval 0.0 to 25.7

SECONDARY outcome

Timeframe: Intraoperative EEG and delirium during PACU stay

Population: Only a total of 38 EEGs with sufficient quality were analyzed

The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown.

Outcome measures

Outcome measures
Measure	Ketamine 0.5 mg/kg n=18 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=9 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=11 Participants Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo. Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Associations of Intraoperative EEG Patterns With PACU Delirium Positive Delirium for PACU	10.0 Percentage of cumulative power Standard Deviation 5.0	7.0 Percentage of cumulative power Standard Deviation 5.0	7.0 Percentage of cumulative power Standard Deviation 6.0
Associations of Intraoperative EEG Patterns With PACU Delirium Negative Delirium for PACU	7.0 Percentage of cumulative power Standard Deviation 1.0	5.0 Percentage of cumulative power Standard Deviation 6.0	6.0 Percentage of cumulative power Standard Deviation 4.0

Adverse Events

Ketamine 0.5 mg/kg

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Ketamine 1.0 mg/kg

Serious events: 9 serious events

Other events: 5 other events

Deaths: 1 deaths

Placebo

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ketamine 0.5 mg/kg n=21 participants at risk Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=26 participants at risk Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=24 participants at risk Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Nervous system disorders Delirium	4.8% 1/21 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	4.2% 1/24 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Nervous system disorders Stroke	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	3.8% 1/26 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Vascular disorders Facial artery clot	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	4.2% 1/24 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Musculoskeletal and connective tissue disorders Surgical wound dehiscence	4.8% 1/21 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Vascular disorders Carotid injury	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	3.8% 1/26 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Gastrointestinal disorders Dysphagia	4.8% 1/21 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	11.5% 3/26 • Number of events 3 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Musculoskeletal and connective tissue disorders Post-operative wound abscess	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	3.8% 1/26 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Nervous system disorders Bilateral MCA; PCA transcortical acute infarcts	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	3.8% 1/26 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Cardiac disorders NSTEMI	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	3.8% 1/26 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Infections and infestations Sepsis	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Musculoskeletal and connective tissue disorders Partial flap necrosis	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	3.8% 1/26 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Musculoskeletal and connective tissue disorders Exposed tendon of left forearm free flap	4.8% 1/21 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.

Other adverse events

Other adverse events
Measure	Ketamine 0.5 mg/kg n=21 participants at risk Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Ketamine 1.0 mg/kg n=26 participants at risk Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.	Placebo n=24 participants at risk Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
Nervous system disorders Agitation	4.8% 1/21 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	7.7% 2/26 • Number of events 2 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Psychiatric disorders Anxiety	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	3.8% 1/26 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	8.3% 2/24 • Number of events 2 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Psychiatric disorders Hallucinations	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	4.2% 1/24 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Nervous system disorders Transient left sided weakness	4.8% 1/21 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
General disorders Somnolence	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	4.2% 1/24 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Psychiatric disorders Depression	4.8% 1/21 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/26 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
General disorders Restlessness	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	3.8% 1/26 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.
Vascular disorders Hypertension	0.00% 0/21 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	3.8% 1/26 • Number of events 1 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.	0.00% 0/24 • The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively. If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.

Additional Information

Dr. Amit Prabhakar

Emory University

Phone: 404-686-2747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place