Trial Outcomes & Findings for Effect of Ketamine on Analgesia Post-Cardiac Surgery (NCT NCT02925858)

Results Overview

Opioids used, in Dilaudid equivalents

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

First 48 hours after arrival to the ICU

Results posted on

2019-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Control Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Overall Study STARTED	42	38
Overall Study COMPLETED	42	38
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 n=42 Participants Bolus 0.5mg/kg, Infusion 0.5mg/kg/hr	Placebo n=38 Participants Normal Saline 0.025cc/kg bolus, 0.025cc/kg/hr	Total n=80 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 9.6 • n=42 Participants	67.1 years STANDARD_DEVIATION 8.6 • n=38 Participants	66.5 years STANDARD_DEVIATION 9.1 • n=80 Participants
Sex: Female, Male Female	4 Participants n=42 Participants	5 Participants n=38 Participants	9 Participants n=80 Participants
Sex: Female, Male Male	38 Participants n=42 Participants	33 Participants n=38 Participants	71 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	42 Participants n=42 Participants	38 Participants n=38 Participants	80 Participants n=80 Participants
Body Mass Index (kg/m^2)	29.0 kg/m^2 STANDARD_DEVIATION 4.2 • n=42 Participants	28.0 kg/m^2 STANDARD_DEVIATION 4.0 • n=38 Participants	28.5 kg/m^2 STANDARD_DEVIATION 4.1 • n=80 Participants
Cardiopulmonary Bypass time (mins)	105.4 mins STANDARD_DEVIATION 33.7 • n=42 Participants	108.2 mins STANDARD_DEVIATION 29.6 • n=38 Participants	106.7 mins STANDARD_DEVIATION 31.5 • n=80 Participants
Cross Clamp Time (mins)	83.6 minutes STANDARD_DEVIATION 33.4 • n=42 Participants	82.7 minutes STANDARD_DEVIATION 25.6 • n=38 Participants	83.6 minutes STANDARD_DEVIATION 33.4 • n=80 Participants
Intraoperative Sufentanil per kg	2.17 mcg/kg STANDARD_DEVIATION 1.11 • n=42 Participants	1.96 mcg/kg STANDARD_DEVIATION 0.86 • n=38 Participants	2.07 mcg/kg STANDARD_DEVIATION 1.07 • n=80 Participants

PRIMARY outcome

Timeframe: First 48 hours after arrival to the ICU

Opioids used, in Dilaudid equivalents

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=38 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Quantity of Opioids Used in the First 48 Hours Postoperatively	10.71 mg of Dilaudid Interval 9.41 to 12.02	11.14 mg of Dilaudid Interval 9.68 to 12.61

SECONDARY outcome

Timeframe: 24 hours postoperatively

Quantity in mg

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=38 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Quantity of Opioids Used	6.5 mg of Dilaudid Interval 5.75 to 7.24	6.7 mg of Dilaudid Interval 5.94 to 7.45

SECONDARY outcome

Timeframe: Postoperative days 2

Average Pain Score as reported by the patient on a numeric scale ranging from 0 (no pain) to a maximum of 10 points (worst pain imaginable)

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=38 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Pain Scores (Visual Analog Scale)	2 score on a scale Interval 0.0 to 4.25	2 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 48 hours after ICU arrival

Whether or not the patient suffered from nausea and vomiting after surgery which required treatment

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=38 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Postoperative Nausea and Vomiting	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 day - 2 weeks

Number of days spent in the intensive care unit

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=38 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Intensive Care Unit Length of Stay	1 days Interval 0.0 to 3.0	2 days Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 5 days - 2 weeks

number of days spent in the hospital, starting from the day of surgery

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=38 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Hospital Length of Stay	8 days Interval 3.0 to 13.0	7 days Interval 2.0 to 12.0

SECONDARY outcome

Timeframe: 4 hours - 2 weeks

Number of minutes from the time of ICU arrival to extubation

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=38 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Time to Extubation	539 minutes Interval 397.0 to 682.0	494 minutes Interval 383.0 to 605.0

SECONDARY outcome

Timeframe: ICU stay

Delirium as assessed by a positive CAM-ICU score during the ICU stay

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=38 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Delirium	11 Participants	7 Participants

SECONDARY outcome

Timeframe: During hospital stay

Time from ICU arrival until patient able to mobilize to chair, measured in hours

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=36 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Time to Mobilization	32 hours Interval 26.0 to 40.0	23 hours Interval 20.0 to 27.0

SECONDARY outcome

Timeframe: 1 week postoperatively

Time from ICU arrival until patient able to ambulate, measured in hours

Outcome measures

Outcome measures
Measure	Ketamine n=42 Participants Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)	Placebo n=36 Participants Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution\_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight
Time to Ambulation	63 hours Interval 54.0 to 76.0	56 hours Interval 46.0 to 64.0

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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 Matthew Cameron

Jewish General Hospital

Phone: 514-340-8222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place