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

Not Applicable

Completed

• Conditions: Anxiety and Fear
• Interventions: Drug: Patients who received Dexmedetomodine; Drug: patients who received propofol-fentanyl

• Registration Number: NCT06148103
• Lead Sponsor: Zulekha Hospitals

Brief Summary

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.

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 Timeline

• Study Start: 2021-12-05
• Primary Completion: 2023-05-06
• Study Completion: 2023-05-06
• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-18
• Last Update Submitted: 2023-11-18
• Study First Posted: 2023-11-28
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D group	Patients who received Dexmedetomodine	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).
PF group	patients who received propofol-fentanyl	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.

Primary Outcome Measures

Name	Time	Method
The quality of painless sedation during colonoscopy.	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 Outcome Measures

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

Trial Locations

Locations (1)

Al-Azhar faculty of medicine; 🇪🇬 Cairo, Egypt