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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety and Fear
• Intervention / Treatment: Drug: Patients who received Dexmedetomodine; Drug: patients who received propofol-fentanyl

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12546
    • Al-Azhar Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

• Inclusion Criteria:

  1. both sexes
  2. 21-60 years old, with
  3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: D group; Patients who received Dexmedetomidine. The starting dose of dexmedetomidine was 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).	Drug: Patients who received Dexmedetomodine; 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
Other: PF group; Patients who received Propofol-Fentanyl infusions. Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively.	Drug: patients who received propofol-fentanyl; Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively.; Other Names: PF group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of painless sedation during colonoscopy.	The patient's ability to cooperate and perform the procedure was evaluated using a 10-point numerical rating scale (NRS).	From start of procedure to 120 minutes after end of colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of adverse events, Prevalence of adverse effects	incidence of adverse events, hemodynamic instability, failure to provide adequate sedation.	from start of procedure to 120 minutes after end of colonoscopy

Collaborators and Investigators

• Sponsor: Zulekha Hospitals
• Collaborators: Al-Azhar University
• Investigators: Principal Investigator: sameh H Seyam, professor, Assistant professor, Anesthesiology, Intensive care and pain management

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2021
• Primary Completion (Actual): May 6, 2023
• Study Completion (Actual): May 6, 2023

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 18, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 18, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Propofol
• Other Study ID Numbers: 00385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No