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Conscious Sedation for Outpatient Colonoscopy

Sponsor
Menoufia University (Other)
Overall Status
Completed
CT.gov ID
NCT03925779
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
18.7
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
A blinded investigator that was not involved in the anaesthetic management of the patients, collected the intra-operative and postoperative data. The patients and colonoscopist were blinded to group allocation. For blinding purposes, two drug infusion pumps were used in every patient where the infusion pumps and i.v. connection lines were concealed to avoid identification.
Primary Purpose:
Other
Official Title:
Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.
Actual Study Start Date :
Jun 15, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Jan 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: (Dexmedetomidine)Dex group

The patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure

Drug: Dexmedetomidine
dexmedetomidine sedation
Other Names:
  • dexmedetomidine infusion

    		•
    Active Comparator: Propofol-Remifentanil (P-R) group

    Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min.

    Drug: Propofol
    propofol sedation
    Other Names:
  • propofol infusion

    • Drug: Remifentanil
    Remifentanil sedation
    Other Names:
  • Remifentanil infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sedation [Perioperative]

      Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.

    Secondary Outcome Measures

    1. Mean arterial blood pressure [Perioperative]

      Mean arterial blood pressure in mmHg

    2. Heart rate [Perioperative]

      Heart rate in beats/minutes

    3. Oxygen saturation [Perioperative]

      Arterial oxygen saturation as a percentage of the total haemoglobin.

    4. Hypotension [Perioperative]

      Number of patients with hypotension

    5. Bradycardia [Perioperative]

      Number of patients with bradycardia

    6. Analgesia [Perioperative]

      Measured by visual analogue scale [from 0 "no pain" to 10 "worst imaginable pain"]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA I or II physical status

    • 18-65 years

    • Scheduled for elective colonoscopy

    Exclusion Criteria:

    • History of allergy to any of the study drugs

    • Alcohol or drug abuse.

    • Second and third-degree heart block.

    • Morbid obesity.

    • Pregnant and lactating women.

    • Psychiatric disorders.

    • Severe cardiac, respiratory, renal, and liver diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Cairo Shebin El-kom Egypt 32511

    Sponsors and Collaborators

    • Menoufia University

    Investigators

    • Principal Investigator: Abd-Elazeem A Elbakry, MD, Associate professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abd-Elazeem Abd-Elhameed Elbakry, Associate professor of anaesthesia, Menoufia University
    ClinicalTrials.gov Identifier:
    NCT03925779
    Other Study ID Numbers:
    • 2019/3/15/9
    First Posted:
    Apr 24, 2019
    Last Update Posted:
    Jan 8, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dexmedetomidine
    Remifentanil
    Propofol

    Study Results

    No Results Posted as of Jan 8, 2021