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Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy

ConditionsClonidinePropofolSedationColonoscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years.

Both sexes.

American Society of Anesthesiology (ASA) physical status I-II.

Patients undergoing colonoscopy.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Propofol groupActive comparator 1 intervention
Group B: Propofol combined with clonidine groupExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
24 hours postoperatively

Secondary outcomes

1

Heart rate

Heart rate will be recorded at 30 minutes before induction, at induction, and at the end of surgery.

Time frame
Till the end of surgery
2

Mean arterial blood pressure

Mean arterial blood pressure will be recorded at 30 minutes before induction, at induction, and at the end of surgery.

Time frame
Till the end of surgery
3

Side effects

Side effects such as nausea and vomiting, psychological reactions will be noted.

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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