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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Conscious Sedation for Outpatient Colonoscopy

Clinicaltrials.gov identifier NCT03925779

Recruitment Status Completed

First Posted April 24, 2019

Last update posted January 8, 2021

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:Conscious Sedation
  • Intervention/Treatment: Drug: Dexmedetomidine
    Drug: Propofol
    Drug: Remifentanil
  • 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)
  • Primary Purpose: Other
  • Official Title: Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: December 2020
  • Actual Study Completion Date: January 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
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

Drug: Remifentanil
Remifentanil sedation
Outcome Measures
  • Primary Outcome Measures: 1. Sedation [ Time Frame: Perioperative ]
    Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.
  • Secondary Outcome Measures: 1. Mean arterial blood pressure [ Time Frame: Perioperative ]
    Mean arterial blood pressure in mmHg
  • 2. Heart rate [ Time Frame: Perioperative ]
    Heart rate in beats/minutes
  • 3. Oxygen saturation [ Time Frame: Perioperative ]
    Arterial oxygen saturation as a percentage of the total haemoglobin.
  • 4. Hypotension [ Time Frame: Perioperative ]
    Number of patients with hypotension
  • 5. Bradycardia [ Time Frame: Perioperative ]
    Number of patients with bradycardia
  • 6. Analgesia [ Time Frame: Perioperative ]
    Measured by visual analogue scale [from 0 "no pain" to 10 "worst imaginable pain"]
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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
Contacts
Locations

Egypt, Shebin El-kom
Faculty of Medicine
Cairo

Sponsors and Collaborators

Menoufia University

Investigators

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

More Information
  • Responsible Party: Menoufia University
  • ClinicalTrials.gov Identifier: NCT03925779 History of Changes
  • Other Study ID Numbers: 2019/3/15/9
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: January 8, 2021
  • Last Verified: January 2021
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No