Comparison of Remifentanil as a Sole Agent or in Combination With Midazolam Versus Fentanyl/Midazolam During Sedation for Colonoscopy

NACompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 1, 2015

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions
Colonoscopy
Interventions
DRUG

Midazolam, Fentanyl

Two minutes before the colonoscopy procedure, a bolus of midazolam 0.03mg/Kg and 1.5microgram/Kg fentanyl will be given intravenously over 60 sec in group 1. 0.5 mg of midazolam intravenously can be given every two minutes till the patient is sufficiently sedated (sleeping but arousable on calling). The colonoscopy can start at this end point. Increments of 0.5mcg/Kg of fentanyl will be given if patient complains of pain, which can be repeated every 5 minutes if there is persistent pain.

DRUG

Midazolam, Remifentanil

The patient in group 2 Target controlled infusion of Remifentanil to 3.0 ng/ml will be started 2 minutes before procedure. The patient will then be given same doses of midazolam in 0.5 mg increments till sedated sufficiently (sleeping but arousable on verbal command). During Colonoscopy the dose of Remifentanil could be increased by 0.5ng/ml if patient complained of pain upto 4.0ng/ml.

DRUG

Remifentanil

The group 3 patient will receive only Remifentanil in the same doses as given in group

Trial Locations (1)

945

Awali Hospital, Manama

All Listed Sponsors
lead

King Hamad University Hospital, Bahrain

OTHER

NCT03037892 - Comparison of Remifentanil as a Sole Agent or in Combination With Midazolam Versus Fentanyl/Midazolam During Sedation for Colonoscopy | Biotech Hunter | Biotech Hunter