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

NCT06148103 | Completed

• 1 other identifier: 00385
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety and Fear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• incidence of adverse events, Prevalence of adverse effects

  from start of procedure to 120 minutes after end of colonoscopy

Study Arms (2)

D group

OTHER

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

PF group

OTHER

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

Interventions

Patients who received Dexmedetomodine DRUG

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).

Also known as: D group

D group

patients who received propofol-fentanyl DRUG

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

Also known as: PF group

PF group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• both sexes
• years old, with
• ASA physical status -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zulekha Hospitals: lead
• Al-Azhar University: collaborator

Study Sites (1)

Al-Azhar faculty of medicine

Cairo, 12546, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• sameh H Seyam, professor

  Assistant professor, Anesthesiology, Intensive care and pain management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 28, 2023
• Study Start: December 5, 2021
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)