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

Summary

Colonoscopy is one of the most commonly performed outpatient procedure for diagnosis and treatment of lower gastrointestinal tract disorders. It has been largely accepted as an effective tool for colorectal cancer(CRC) screening, given its ability to detect and remove identified polyps. Increased colonoscopy utilization is associated with the observed decline in the incidence of CRC and its diagnosis at earlier stages. Diagnostic and therapeutic colonoscopy can successfully be performed using moderate sedation in the ambulatory setting. Techniques of sedation must guarantee the comfort and safety of patients, and at the same time allow a rapid turnover of patients.. An anaesthetic agent with rapid onset and offset of action, and convenient titration of anaesthetic/analgesic depth as well as rapid recovery to enable discharge from the endoscopy unit as soon as possible would be ideal as most such procedures are performed in the Non-Operating Room Anaesthesia(NORA) settings.

There is recent interest in the use of Remifentanil, in endoscopic units as it might have advantages over other drugs because of its profound analgesic effects, rapid onset and offset time and rapid titration to the individual patient's requirements and intermittent pain during colonoscopy.

The aim of this randomized study is to test the hypothesis that a colonoscopy of good quality in terms of pain relief, patient comfort and discharge times with less cardiorespiratory side effects can be performed using Remifentanil as a sole agent as compared with the standard midazolam/fentanyl protocol. The second group combining Remifentanil with Midazolam is taken to evaluate if there is any advantage of adding an anxiolytic amnesic drug as used in the standard Midazolam/Fentanyl Protocol.

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

Sponsors & Collaborators

• King Hamad University Hospital, Bahrain

  lead OTHER

Principal Investigators

• Reeta Singh, MD DNBE MBA · Awali Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-06-01

Primary Completion

2018-05-31

Completion

2018-05-31

Countries

• Bahrain

Study Locations