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

Sponsor

Zulekha Hospitals (Other)

Overall Status

Completed

CT.gov ID

NCT06148103

Collaborator

Al-Azhar University (Other)

Enrollment

Location

Arms

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety and Fear	Drug: Patients who received Dexmedetomodine Drug: patients who received propofol-fentanyl	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Dec 5, 2021

Actual Primary Completion Date :

May 6, 2023

Actual Study Completion Date :

May 6, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Azhar faculty of medicine	Cairo		Egypt	12546

Sponsors and Collaborators

Zulekha Hospitals
Al-Azhar University

Investigators

Principal Investigator: sameh H Seyam, professor, Assistant professor, Anesthesiology, Intensive care and pain management

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zulekha Hospitals

ClinicalTrials.gov Identifier:

NCT06148103

Other Study ID Numbers:

00385

First Posted:

Nov 28, 2023

Last Update Posted:

Nov 28, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Fentanyl

Propofol

Study Results

No Results Posted as of Nov 28, 2023