Trial Outcomes & Findings for Perioperative Ketamine for Pain With Gastric Bypass (NCT NCT03448068)

Results Overview

Measured in oral morphine equivalents

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

approximately 48 hours after induction of anesthesia

Results posted on

2021-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Therapy Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy Subjects received standard of care anesthesia
Overall Study STARTED	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine Therapy n=17 Participants Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=17 Participants Subjects received standard of care anesthesia	Total n=34 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 11.5 • n=17 Participants	48.8 years STANDARD_DEVIATION 10.2 • n=17 Participants	51.5 years STANDARD_DEVIATION 11.0 • n=34 Participants
Sex: Female, Male Female	12 Participants n=17 Participants	15 Participants n=17 Participants	27 Participants n=34 Participants
Sex: Female, Male Male	5 Participants n=17 Participants	2 Participants n=17 Participants	7 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	17 participants n=17 Participants	17 participants n=17 Participants	34 participants n=34 Participants

PRIMARY outcome

Timeframe: approximately 48 hours after induction of anesthesia

Measured in oral morphine equivalents

Outcome measures

Outcome measures
Measure	Ketamine Therapy n=17 Participants Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=17 Participants Subjects received standard of care anesthesia
Total Cumulative Perioperative Opioid Dose	179.9 Morphine Equivalents Standard Deviation 113.1	248.6 Morphine Equivalents Standard Deviation 91.6

SECONDARY outcome

Timeframe: approximately 0-12 hours post operatively

Patient reported pain scores at 0-12 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.

Outcome measures

Outcome measures
Measure	Ketamine Therapy n=17 Participants Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=17 Participants Subjects received standard of care anesthesia
Average Pain Score 0-12 Hours	3.4 mm Standard Deviation 2.2	4.2 mm Standard Deviation 1.5

SECONDARY outcome

Timeframe: approximately 12-24 hours post operatively

Patient reported pain scores at 12-24 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.

Outcome measures

Outcome measures
Measure	Ketamine Therapy n=17 Participants Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=17 Participants Subjects received standard of care anesthesia
Average Pain Score 12-24 Hours	2.6 mm Standard Deviation 1.9	3.7 mm Standard Deviation 1.4

SECONDARY outcome

Timeframe: approximately 24-48 hours post operatively

Population: 2 subjects were discharged early so data was not collected or analyzed for 1 subject from the ketamine therapy group and 1 subject from the standard therapy group

Patient reported pain scores at 24-48 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.

Outcome measures

Outcome measures
Measure	Ketamine Therapy n=16 Participants Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=16 Participants Subjects received standard of care anesthesia
Average Pain Score 24-48 Hours	3.1 mm Standard Deviation 1.9	3.8 mm Standard Deviation 1.5

SECONDARY outcome

Timeframe: 12 hours, 24 hours, and 48 hours

Number of subject to experience post-operative nausea

Outcome measures

Outcome measures
Measure	Ketamine Therapy n=17 Participants Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=17 Participants Subjects received standard of care anesthesia
Post-Operative Nausea Nausea 1st 12 hours	10 Participants	9 Participants
Post-Operative Nausea Nausea 2nd 12 hours	6 Participants	2 Participants
Post-Operative Nausea Nausea 2nd 24 hours	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Arrival at hospital until discharge from hospital, approximately 2 days

Length of hospital stay measured in hours

Outcome measures

Outcome measures
Measure	Ketamine Therapy n=17 Participants Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=17 Participants Subjects received standard of care anesthesia
Length of Stay in Hospital	43.9 Hours Standard Deviation 18.0	36.7 Hours Standard Deviation 14.0

SECONDARY outcome

Timeframe: approximately 1-2 days post-operatively

Self-reported questionnaire at the time of discharge from the hospital rating satisfaction of pain treatment while in the hospital using a scale of 0= extremely dissatisfied, 10 = extremely satisfied.

Outcome measures

Outcome measures
Measure	Ketamine Therapy n=17 Participants Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=17 Participants Subjects received standard of care anesthesia
Patient Satisfaction With Pain Control at Time of Hospital Discharge	9.5 score on a scale Standard Deviation 0.9	8.3 score on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: approximately 30 days post-operatively

Self-reported questionnaire at the time of first post-operative visit with the surgeon, rating the worst amount of pain since being discharged from the hospital using a scale of 0= no pain, 10 = worst pain possible.

Outcome measures

Outcome measures
Measure	Ketamine Therapy n=17 Participants Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=17 Participants Subjects received standard of care anesthesia
Patient Satisfaction With Pain Control at Postoperative Visit	3.6 score on a scale Standard Deviation 3.4	6.2 score on a scale Standard Deviation 2.3

Adverse Events

Ketamine Therapy

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Standard Therapy

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine Therapy n=17 participants at risk Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours	Standard Therapy n=17 participants at risk Subjects received standard of care anesthesia
General disorders Nausea	76.5% 13/17 • Number of events 19 • Adverse events were collected 30 days following surgery for each participant, over a study duration of approximately 48 months	64.7% 11/17 • Number of events 14 • Adverse events were collected 30 days following surgery for each participant, over a study duration of approximately 48 months

Additional Information

Dr. Andrew W. Gorlin

Mayo Clinic

Phone: 480-342-2446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place