Effect of Ketamine on Analgesia Post-Cardiac Surgery

Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Ketamine Hydrochloride; Drug: Normal Saline Flush, 0.9% Injectable Solution_#1

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intraoperative infusion of ketamine	Drug: Ketamine Hydrochloride; Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)
Placebo Comparator: Control; Control group receiving a saline infusion	Drug: Normal Saline Flush, 0.9% Injectable Solution_#1; Normal saline infusion mimicking infusion rate of ketamine for a given weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of Opioids Used in the First 48 Hours Postoperatively	Opioids used, in Dilaudid equivalents	First 48 hours after arrival to the ICU

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jewish General Hospital
• Investigators: Principal Investigator: Matthew Cameron, MD, Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 27, 2018

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Ketamine; Cardiac surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 16-289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will provide all uncoded data
• IPD Sharing Time Frame: Upon request, starting 6 months after publication
• IPD Sharing Access Criteria: For planned meta-analyses
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No