Clinical trial

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

Name

00385

Description

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.

Trial arms

Trial start

2021-12-05

Estimated PCD

2023-05-06

Trial end

2023-05-06

Status

Completed

Treatment

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).

Arms:

D group

Other names:

D group

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.

Arms:

PF group

Other names:

PF group

Size

Primary endpoint

The quality of painless sedation during colonoscopy.

From start of procedure to 120 minutes after end of colonoscopy

Eligibility criteria

* 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-11-28

1 organization

2 products

1 indication

Organization

Product

Indication

Product