Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06507410

Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy

Led by Tanta University · Updated on 2024-07-23

62

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of adding clonidine to propofol sedation in patients undergoing colonoscopy. The study aims to compare the safety, patient satisfaction, and efficiency of propofol alone versus propofol combined with clonidine. Colonoscopy is a common procedure used for prevention, diagnosis, and treatment of lower digestive tract conditions, and sedation improves patient comfort and procedure quality. The trial explores how clonidine, which acts on alpha2 adrenoceptors to produce sedation and analgesia, may affect sedation outcomes alongside propofol. Participants will be randomly assigned to one of two groups. One group receives propofol sedation maintained by continuous infusion via syringe pump, starting at 25-75 micrograms per kilogram per minute intravenously for 10 to 15 minutes, then adjusted based on clinical response. The other group receives an intravenous dose of clonidine (2 micrograms per kilogram) 30 minutes before starting propofol sedation, administered over 10 minutes. Sedation onset and dosing are carefully regulated to avoid unnecessary sedative exposure. During the study, patients will be monitored for heart rate and blood pressure throughout the colonoscopy procedure. Patient satisfaction and side effects will be assessed 24 hours after surgery. Researchers will track vital signs until the procedure ends and evaluate overall safety and comfort. The study runs from July to September 2024 and includes adults aged 18 to 65 undergoing colonoscopy with specific health criteria.

CONDITIONS

Brief Title

Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years
  • Both sexes
  • American Society of Anesthesiology (ASA) physical status I-II
  • Patients undergoing colonoscopy
Not Eligible

You will not qualify if you...

  • Recent history of colonoscopy
  • Previous colonic resection
  • Severe heart failure (ejection fraction < 30%)
  • Known hypersensitivity to propofol or clonidine
  • Need for anesthetic drugs outside the study protocol

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Sedation administered during the colonoscopy procedure

Participants receive sedation for colonoscopy with either propofol alone or propofol combined with clonidine. Sedation is administered by intravenous infusion and injection as per group assignment to reduce anxiety and discomfort during the procedure.

1 procedure visit (in-person)

Follow-up

Duration - 24 hours postoperatively

Participants are monitored for patient satisfaction and side effects for 24 hours after the colonoscopy procedure.

1 follow-up visit or contact within 24 hours

Trial Site Locations

Total: 1 location

1

Tanta University

Tanta, El-Gharbia, Egypt, 31527

Actively Recruiting

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Research Team

R

Rabab M Mohamed, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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