Effect of Ketamine on Analgesia Post-Cardiac Surgery

NCT ID: NCT02925858

Last Updated: 2019-09-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2018-11-27

Brief Summary

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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

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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

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Intraoperative infusion of ketamine

Group Type EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Normal Saline Flush, 0.9% Injectable Solution_#1

Intervention Type DRUG

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

Interventions

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Normal Saline Flush, 0.9% Injectable Solution_#1

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

Intervention Type DRUG

Ketamine Hydrochloride

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthew Cameron

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Cameron, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish General Hospital

Locations

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Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-289

Identifier Type: -

Identifier Source: org_study_id

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