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

NCT03037892 | Completed DMC

• 1 other identifier: KHUH/Research/No.89/2015
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• The Recovery Time

  Every 5 minutes till a score of 10/10 achieved on Aldrete Score

  30 min

• propofol consumption

  Number of patients in each group who had to receive propofol due to loss of cooperation

  60 minutes

Secondary Outcomes (4)

• Endoscopist Satisfaction

  60 min

• Incidence of Patient's Recall.

  6 hours

• Patient satisfaction

  6 hours

• Side effects

  6 hours

Study Arms (3)

Midazolam and Fentanyl

ACTIVE COMPARATOR

Midazolam and 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, Fentanyl

Midazolam and Remifentanil

EXPERIMENTAL

Midazolam and Remifentanil 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: Midazolam, Remifentanil

Remifentanil

EXPERIMENTAL

Remifentanil Group Patients will receive only Remifentanil in the same doses as given in group 2. During the procedure if the pain is excessive and persistent in spite of increasing the respective doses as prescribed in each group, or causing loss of cooperation of patient and interfering in the performance of procedure, the patients will be given sleep dose of Inj Propofol and further anaesthesia care as required will be provided for same.

Drug: Remifentanil

Interventions

Midazolam, Fentanyl DRUG

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.

Midazolam and Fentanyl

Midazolam, Remifentanil DRUG

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.

Midazolam and Remifentanil

Remifentanil DRUG

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

Remifentanil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18-75 years
• ASA Grade I, II and controlled ASA III.

You may not qualify if:

• Patient Refusal
• Patients with psychiatric or Emotional Disorders
• Previous adverse reaction to any of the drugs used
• History of addiction to opiates/sedatives/alcohol
• ASA Grade 3-4 patients with clinically significant or uncontrolled cardiovascular or respiratory disease.
• Pregnancy
• Age \<=18years

Sponsors & Collaborators

• King Hamad University Hospital, Bahrain: lead

Study Sites (1)

Awali Hospital

Manama, 945, Bahrain

Location

MeSH Terms

Interventions

Midazolam; Fentanyl; Remifentanil

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Reeta Singh, MD DNBE MBA

  Awali Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: January 31, 2017
• Study Start: June 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

BA (1)