Pilot Study Comparing Treatment With Dexmedetomidine to Midazolam for Symptom Control in Advanced Cancer Patients

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 30, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Pain IntractableDeliriumDyspneaNausea
Interventions
DRUG

Dexmedetomidine

"Study drugs will be administered by continuous subcutaneous infusion using a weight based protocol at a rate between 1.0 to 5.5 mL/hr.~* The study drug will be started at a rate of 1.0 mL/hr.~* The infusion rate is incremented by 0.5 ml/hr every 30 minutes until acceptable symptom control, bradycardia (heart rate \< 40) or hypotension (systolic blood pressure \< 80) prevent further increase or maximum infusion rate of 5.5 ml/hr, whichever comes first. Achievement of acceptable symptom control will be defined, for purposes of this trial, as a consensus between reports from patient, family care giver and attending registered nurse"

DRUG

Midazolam

"Study drugs will be administered by continuous subcutaneous infusion using a weight based protocol at a rate between 1.0 to 5.5 mL/hr.~* The study drug will be started at a rate of 1.0 mL/hr.~* The infusion rate is incremented by 0.5 ml/hr every 30 minutes until acceptable symptom control, bradycardia (heart rate \< 40) or hypotension (systolic blood pressure \< 80) prevent further increase or maximum infusion rate of 5.5 ml/hr, whichever comes first. Achievement of acceptable symptom control will be defined, for purposes of this trial, as a consensus between reports from patient, family care giver and attending registered nurse"

Trial Locations (1)

V2S 0C2

Abbotsford Regional Hospital and Cancer Center, Abbotsford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Fraser Health

OTHER