The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 13, 2018

Primary Completion Date

October 17, 2018

Study Completion Date

October 17, 2018

Conditions
Anesthesia
Interventions
DRUG

Ketamine Injectable Solution

"Once IV access has been obtained and a facemask has been applied for pre-oxygenation, the loading dose (0.25 mg/kg) of the study drug will be given over 60 seconds and the fixed infusion (5 mcg/kg/min to a maximum of 60 mg/hour) will be initiated by the anesthetist through the pump interface.~The study drug will be infused at a constant rate of 5 mcg/kg/min throughout the maintenance phase, until the end of the procedure (last suture), up to a maximum cumulative dose of 100 mg. If at any point the anesthesiologist feels that it is clinically necessary to reduce the amount of study drug infusion rate, they may opt to reduce the infusion rate by 50% (to 2.5 mcg/kg/min), or stop the infusion entirely."

OTHER

Placebo

Participants in the control group will receive an equivalent volume bolus and infusion of normal saline to mimic the ketamine infusion in the ketamine group.

Trial Locations (1)

V3H 3W9

Fraser Health: Eagle Ridge Hospital, Port Moody

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Fraser Health

OTHER

collaborator

Office of Naval Research (ONR)

FED

lead

NeuroWave Systems Inc.

INDUSTRY

NCT03009409 - The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia | Biotech Hunter | Biotech Hunter