Effect of Ketamine on Analgesia Post-Cardiac Surgery

Jewish General Hospital80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative

Interventions

Normal Saline Flush, 0.9% Injectable Solution_#1DRUG

Normal saline infusion mimicking infusion rate of ketamine for a given weight

Ketamine HydrochlorideDRUG

Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Jewish General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Quantity of Opioids Used in the First 48 Hours Postoperatively

Opioids used, in Dilaudid equivalents

Time frame: First 48 hours after arrival to the ICU

Secondary Outcomes

Quantity of Opioids Used

Quantity in mg

Time frame: 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)

Time frame: Postoperative days 2

Postoperative Nausea and Vomiting

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

Time frame: 48 hours after ICU arrival

Intensive Care Unit Length of Stay

Number of days spent in the intensive care unit

Time frame: 1 day - 2 weeks

Hospital Length of Stay

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

Time frame: 5 days - 2 weeks

Time to Extubation

Number of minutes from the time of ICU arrival to extubation

Time frame: 4 hours - 2 weeks

Delirium

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

Time frame: ICU stay

Data from ClinicalTrials.gov

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