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

Anxiety and Fear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06148103
• Other study ID #: 00385
• Status: Completed
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: May 6, 2023

Study information

• Verified date: November 2023
• Source: Zulekha Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 6, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Anxiety and Fear

Intervention

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).
• 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.

Locations

Country	Name	City	State
Egypt	Al-Azhar faculty of medicine	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Zulekha Hospitals	Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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