Effect of Ketamine on Analgesia Post-Cardiac Surgery

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Ketamine Hydrochloride; Drug: Normal Saline Flush, 0.9% Injectable Solution_#1

• Registration Number: NCT02925858
• Lead Sponsor: Jewish General Hospital

Brief Summary

Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.

Detailed Description

This is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative Ketamine administration on pain after coronary artery bypass surgery. Patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. Opioid dose administered in the first 48 hours will then be documented as the primary outcome

Study Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Study Start: 2017-08-28
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-27
• Results First Submitted: 2019-03-01
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-06
• Last Update Submitted: 2019-08-06
• Results First Posted: 2019-09-06
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery

Exclusion Criteria

• Minimally invasive cardiac surgery
• Preoperative opioid use
• Preoperative hepatic or renal dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Ketamine Hydrochloride	Intraoperative infusion of ketamine
Control	Normal Saline Flush, 0.9% Injectable Solution_#1	Control group receiving a saline infusion

Primary Outcome Measures

Name	Time	Method
Quantity of Opioids Used in the First 48 Hours Postoperatively	First 48 hours after arrival to the ICU	Opioids used, in Dilaudid equivalents

Secondary Outcome Measures

Name	Time	Method
Postoperative Nausea and Vomiting	48 hours after ICU arrival	Whether or not the patient suffered from nausea and vomiting after surgery which required treatment
Intensive Care Unit Length of Stay	1 day - 2 weeks	Number of days spent in the intensive care unit
Time to Mobilization	During hospital stay	Time from ICU arrival until patient able to mobilize to chair, measured in hours
Pain Scores (Visual Analog Scale)	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)
Quantity of Opioids Used	24 hours postoperatively	Quantity in mg
Hospital Length of Stay	5 days - 2 weeks	number of days spent in the hospital, starting from the day of surgery
Time to Extubation	4 hours - 2 weeks	Number of minutes from the time of ICU arrival to extubation
Delirium	ICU stay	Delirium as assessed by a positive CAM-ICU score during the ICU stay
Time to Ambulation	1 week postoperatively	Time from ICU arrival until patient able to ambulate, measured in hours

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada