Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy

NCT06507410 | Recruiting

• 1 other identifier: 36264PR725/6/24
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to compare safety, satisfaction, and efficiency outcomes of propofol versus propofol with clonidine in patients undergoing colonoscopy.

Conditions

Clonidine; Propofol; Sedation; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Patient's satisfaction level will be assessed with a Likert five-item scoring system (1 = Not at all satisfied, 2 = slightly satisfied, 3 = somewhat satisfied, 4 = very satisfied, and 5 = extremely satisfied).

  24 hours postoperatively

Secondary Outcomes (3)

• Heart rate

  Till the end of surgery

• Mean arterial blood pressure

  Till the end of surgery

• Side effects

  24 hours postoperatively

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

Patients will receive induction of sedation as follow: Continuous propofol infusion will be given with syringe pump for maintenance, with the initial rate set at 25-75 mic/kg/min IV during the first 10-15 min. To avoid administering sedatives at rates greater than clinically necessary, infusion rates will be gradually titrated to 25-50 mic/kg/min and regulated with the clinical response, with an onset of peak drug action expected to occur within 2 min.

Drug: Propofol

Propofol combined with clonidine group

EXPERIMENTAL

Patients will receive 2 μg/kg of clonidine for injection intravenously 30 min before induction of sedation, administered over 10 min.

Drug: Propofol combined with clonidine

Interventions

Propofol DRUG

Continuous propofol infusion will be given with syringe pump for maintenance, with the initial rate set at 25-75 mic/kg/min IV during the first 10-15 min. To avoid administering sedatives at rates greater than clinically necessary, infusion rates will be gradually titrated to 25-50 mic/kg/min and regulated with the clinical response, with an onset of peak drug action expected to occur within 2 min.

Propofol group

Propofol combined with clonidine DRUG

Patients will receive 2 μg/kg of clonidine for injection intravenously 30 min before induction of sedation, administered over 10 min.

Propofol combined with clonidine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Patients undergoing colonoscopy.

You may not qualify if:

• Patients had recent history of colonoscopy.
• Previous colonic resection.
• Severe heart failure (ejection fraction \< 30%).
• Known history of hypersensitivity to propofol or clonidine and any need for anesthetic drug administration other than the study protocol.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Propofol; Clonidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Rabab M Mohamed, MD

CONTACT

00201069122935; rabmoh_30@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 18, 2024
• Study Start: July 20, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)