NCT02925858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

August 28, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

October 4, 2016

Results QC Date

March 1, 2019

Last Update Submit

August 6, 2019

Conditions

Pain, Postoperative

Keywords

KetamineCardiac surgeryPain

Outcome Measures

Primary Outcomes (1)

  • Quantity of Opioids Used in the First 48 Hours Postoperatively

    Opioids used, in Dilaudid equivalents

    First 48 hours after arrival to the ICU

Secondary Outcomes (9)

  • Quantity of Opioids Used

    24 hours postoperatively

  • Pain Scores (Visual Analog Scale)

    Postoperative days 2

  • Postoperative Nausea and Vomiting

    48 hours after ICU arrival

  • Intensive Care Unit Length of Stay

    1 day - 2 weeks

  • Hospital Length of Stay

    5 days - 2 weeks

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Intraoperative infusion of ketamine

Drug: Ketamine Hydrochloride

Control

PLACEBO COMPARATOR

Control group receiving a saline infusion

Drug: Normal Saline Flush, 0.9% Injectable Solution_#1

Interventions

Normal Saline Flush, 0.9% Injectable Solution_#1DRUG

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

Control
Ketamine HydrochlorideDRUG

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr Matthew Cameron
Organization
Jewish General Hospital
matthew.cameron@mcgill.ca
514-340-8222

Study Officials

  • Matthew Cameron, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 6, 2016

Study Start

August 28, 2017

Primary Completion

November 1, 2018

Study Completion

November 27, 2018

Last Updated

September 6, 2019

Results First Posted

September 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Will provide all uncoded data

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Upon request, starting 6 months after publication
Access Criteria
For planned meta-analyses

Locations

CA(1)