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OpenTrials
Completed

NCT Number: NCT03925779

Conscious Sedation for Outpatient Colonoscopy

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

dexmedetomidine sedation

Other names: dexmedetomidine infusion

Propofol

Drug

propofol sedation

Other names: propofol infusion

Remifentanil

Drug

Remifentanil sedation

Other names: Remifentanil infusion

Primary outcomes

  1. Sedation

    Time frame: Perioperative

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

Secondary outcomes

  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"]

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 24, 2019
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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