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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06148103
Enrollment
60
Registered
2023-11-28
Start date
2021-12-05
Completion date
2023-05-06
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and Fear

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.

Interventions

DRUGPatients 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).

DRUGpatients who received propofol-fentanyl

Continued infusions of both fentanyl and propofol were 0.01-0.05 μg kg/ min 25-150 mg/h respectively.

Sponsors

Al-Azhar University
CollaboratorOTHER
Zulekha Hospitals
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
incidence of adverse events, Prevalence of adverse effectsfrom start of procedure to 120 minutes after end of colonoscopyincidence of adverse events, hemodynamic instability, failure to provide adequate sedation.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026