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

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: King Hamad University Hospital, Bahrain
• Treatments: Fentanyl; Midazolam; Remifentanil

Criteria

Inclusion Criteria:

1. Patients between 18-75 years

2. ASA Grade I, II and controlled ASA III.

Exclusion Criteria:

1. Patient Refusal

2. Patients with psychiatric or Emotional Disorders

3. Previous adverse reaction to any of the drugs used

4. History of addiction to opiates/sedatives/alcohol

5. ASA Grade 3-4 patients with clinically significant or uncontrolled cardiovascular or respiratory disease.

6. Pregnancy

7. Age <=18years