Effect of Ketamine on Analgesia Post-Cardiac Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925858
• Other study ID #: 16-289
• Status: Completed
• Phase: Phase 4
• Start date: August 28, 2017
• Est. completion date: November 27, 2018

Study information

• Verified date: August 2019
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 27, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Normal Saline Flush, 0.9% Injectable Solution_#1
Normal saline infusion mimicking infusion rate of ketamine for a given weight
• Ketamine Hydrochloride
Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of Opioids Used in the First 48 Hours Postoperatively	Opioids used, in Dilaudid equivalents	First 48 hours after arrival to the ICU
Secondary	Quantity of Opioids Used	Quantity in mg	24 hours postoperatively
Secondary	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
Secondary	Postoperative Nausea and Vomiting	Whether or not the patient suffered from nausea and vomiting after surgery which required treatment	48 hours after ICU arrival
Secondary	Intensive Care Unit Length of Stay	Number of days spent in the intensive care unit	1 day - 2 weeks
Secondary	Hospital Length of Stay	number of days spent in the hospital, starting from the day of surgery	5 days - 2 weeks
Secondary	Time to Extubation	Number of minutes from the time of ICU arrival to extubation	4 hours - 2 weeks
Secondary	Delirium	Delirium as assessed by a positive CAM-ICU score during the ICU stay	ICU stay
Secondary	Time to Mobilization	Time from ICU arrival until patient able to mobilize to chair, measured in hours	During hospital stay
Secondary	Time to Ambulation	Time from ICU arrival until patient able to ambulate, measured in hours	1 week postoperatively