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

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ClinicalTrials.gov Identifier: NCT03037892
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
King Hamad University Hospital, Bahrain

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.


Condition or disease Intervention/treatment Phase
Colonoscopy Drug: Midazolam, Fentanyl Drug: Midazolam, Remifentanil Drug: Remifentanil Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparative Study to Evaluate the Use of Remifentanil as a Sole Agent or in Combination With Midazolam Versus Fentanyl/Midazolam During Sedation for Colonoscopy
Study Start Date : June 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: Midazolam and Fentanyl
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
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.

Experimental: Midazolam and Remifentanil
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
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.

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




Primary Outcome Measures :
  1. The Recovery Time [ Time Frame: 30 min ]
    Every 5 minutes till a score of 10/10 achieved on Aldrete Score

  2. propofol consumption [ Time Frame: 60 minutes ]
    Number of patients in each group who had to receive propofol due to loss of cooperation


Secondary Outcome Measures :
  1. Endoscopist Satisfaction [ Time Frame: 60 min ]
    Endoscopist Satisfaction scored from 1-10

  2. Incidence of Patient's Recall. [ Time Frame: 6 hours ]
    Any recall and unpleasantness related to recall will be noted

  3. Patient satisfaction [ Time Frame: 6 hours ]
    Patient satisfaction. Will be tested on a numerical scale from 0 (not satisfied at all) to 10 (fully satisfied) at the time of discharge from the hospital.

  4. Side effects [ Time Frame: 6 hours ]
    Side Effects noted in each group for example excessive sedation, nausea, vomiting, pruritis, respiratory depression or apnoea.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037892


Contacts
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Contact: Reeta Singh, MD DNBE MBA 17753350 ext 3350 reeta_singh@bapco.net
Contact: Tariq Hameed, FRCS 17757600 tariq_hameed@bapco.net

Locations
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Bahrain
Awali Hospital Recruiting
Manama, Bahrain, 945
Contact: Reeta Singh, MD DNBE MBA    17753350 ext 3350    reeta_singh@bapco.net   
Contact: Tariq Hameed, FRCS    17757600    Tariq_hameed@bapco.net   
Sub-Investigator: Sameena RAZZAQ, MBBS         
Sponsors and Collaborators
King Hamad University Hospital, Bahrain
Investigators
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Principal Investigator: Reeta Singh, MD DNBE MBA Awali Hospital

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Responsible Party: King Hamad University Hospital, Bahrain
ClinicalTrials.gov Identifier: NCT03037892     History of Changes
Other Study ID Numbers: KHUH/Research/No.89/2015
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Fentanyl
Midazolam
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action