Trial Outcomes & Findings for EEG Studies of Ketamine General Anesthesia (NCT NCT03553758)

Last Updated: 2020-08-26

Results Overview

Average Pain Intensity prior to ketamine induction, 30 minutes post ketamine, 60 minutes post ketamine, 75 minutes post ketamine, and 120 minutes post ketamine. PROMIS Pain Intensity 1a was used to assess pain delivered by a pre-calibrated pain cuff. Scale of 0 (no pain) to 10 (worst imaginable pain).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

16 participants

Primary outcome timeframe

Approximately 125 minutes

Results posted on

2020-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine 15 subjects undergoing ketamine general anesthesia. Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.
Overall Study STARTED	16
Overall Study Completed Screening Visit	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine 15 subjects undergoing ketamine general anesthesia. Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.
Overall Study Lost to Follow-up	1

Baseline Characteristics

EEG Studies of Ketamine General Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=15 Participants 15 subjects undergoing ketamine general anesthesia. Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24 years STANDARD_DEVIATION 3.4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 125 minutes

Population: 1 patient did not complete assessments after recovery of responsiveness.

Outcome measures

Outcome measures
Measure	Ketamine EEG Dynamics n=14 Participants 15 subjects undergoing ketamine general anesthesia. Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.
Average Pain Intensity Pre- and Post-Ketamine Induction Pre-Ketamine	7.9 score on a scale Standard Deviation 0.5
Average Pain Intensity Pre- and Post-Ketamine Induction 30 minutes Post-Ketamine	1.6 score on a scale Standard Deviation 1.6
Average Pain Intensity Pre- and Post-Ketamine Induction 60 minutes Post-Ketamine	4.1 score on a scale Standard Deviation 2.2
Average Pain Intensity Pre- and Post-Ketamine Induction 75 minutes Post-Ketamine	4.3 score on a scale Standard Deviation 2.2
Average Pain Intensity Pre- and Post-Ketamine Induction 120 minutes Post-Ketamine	5.4 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: About 125 minutes

Population: 1 patient did not perform assessments after recovery of responsiveness.

Patients were assessed for dissociation states prior to the induction of ketamine and at 60 minutes, 75 minutes, and 120 minutes after Ketamine was administered. The Clinician Administered Dissociation States Scale was used to measure dissociation. Each section is scored 0 (not at all) to 4 (extreme), and totaled. The minimum total score is 0 (best, no dissociation at all) and the maximum total score is 92 (worst, the most dissociation).

Outcome measures

Outcome measures
Measure	Ketamine EEG Dynamics n=14 Participants 15 subjects undergoing ketamine general anesthesia. Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.
Average Dissociation States Score Pre- and Post-Ketamine Induction Pre-Ketamine	0.2 score on a scale Standard Deviation 0.4
Average Dissociation States Score Pre- and Post-Ketamine Induction 60 minutes post-ketamine	22.1 score on a scale Standard Deviation 17
Average Dissociation States Score Pre- and Post-Ketamine Induction 75 minutes post-ketamine	14.3 score on a scale Standard Deviation 11.6
Average Dissociation States Score Pre- and Post-Ketamine Induction 120 minutes post-ketamine	5.2 score on a scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: About 60 minutes

Population: 1 patient did not complete assessments after recovery of responsiveness.

Midazolam was administered approximately 60 minutes after the administration of Ketamine in order to reduce the effects of Ketamine on dissociation. Dissociation was measured using the Clinician Administered Dissociative States Scale. Each section is scored 0 (not at all) to 4 (extreme), and totaled. The minimum total score is 0 (best, no dissociation at all) and the maximum total score is 92 (worst, the most dissociation). The difference of the mean Clinician Administered Dissociative States Scale before and after Midazolam administration was found.

Outcome measures

Outcome measures
Measure	Ketamine EEG Dynamics n=14 Participants 15 subjects undergoing ketamine general anesthesia. Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.
Difference of the Mean Clinician Administered Dissociative States Scale Before and After Midazolam Administration	10.3 score on a scale Interval 3.4 to 17.1

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Oluwaseun Johnson-Akeju

Massachusetts General Hospital DACCPM

Phone: 617-724-7200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place