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Completed

NCT Number: NCT06148103

A Comparison Between Dexmedetomidine and Propofol-fentanyl Infusions for Sedation for Colonoscopy Procedures

Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for painless sedation or monitored anesthesia care. The aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.

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Key information

Conditions

Anxiety and Fear Anxiety Disorders Mental Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar faculty of medicine

Cairo, 12546, Egypt

About this study

Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for conscious sedation or monitored anesthesia care. Aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.

Patients and methods: Sixty patients of both sexes and 21-60 years old with ASA physical status I-II, were randomly assigned to receive either dexmedetomidine (D group) or propofol-fentanyl (PF group) infusions in equal numbers. Minimal infusion rates of dexmedetomidine (0.1-0.4 μg/kg/h) in the D group and fentanyl (0.01-0.05 μg/kg/min) in the PF group were continued during colonoscopy, which lasted approximately 30 minutes.

Who can participate

Healthy volunteers accepted: Yes

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

  • Inclusion Criteria:
  • both sexes
  • 21-60 years old, with
  • ASA physical status -
  • Exclusion Criteria:
  • severe cardiovascular or respiratory disease
  • (ASA grade ≥III)
  • pregnancy
  • allergies to the drugs being used
  • known alcohol or substance abuse
  • expected communication difficulties with the patient.

Treatment and study plan

Patients who received Dexmedetomodine

Drug

1 microgram/kg over a period of 10 minutes, and then a maintenance infusion was titrated in a range from 0.2-1 μg/kg/h).

Other names: D group

patients who received propofol-fentanyl

Drug

Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively.

Other names: PF group

Primary outcomes

  1. The quality of painless sedation during colonoscopy.

    Time frame: From start of procedure to 120 minutes after end of colonoscopy

    The patient's ability to cooperate and perform the procedure was evaluated using a 10-point numerical rating scale (NRS).

Secondary outcomes

  1. incidence of adverse events, Prevalence of adverse effects

    Time frame: from start of procedure to 120 minutes after end of colonoscopy

    incidence of adverse events, hemodynamic instability, failure to provide adequate sedation.

Sponsors and collaborators

Lead sponsor

Zulekha Hospitals

Other

Collaborators

  • Al-Azhar University

Registry information

Official study title

Sedation for Colonoscopy Procedures Using Dexmedetomidine Versus Propofol-Fentanyl Infusions: A Prospective Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 28, 2023
Registry last updated
Nov 28, 2023

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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