Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy
- Conditions
- PropofolClonidineSedationColonoscopy
- Interventions
- Registration Number
- NCT06507410
- Lead Sponsor
- Tanta University
- 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.
- Detailed Description
Colonoscopy is one of the most common procedures in the world, Colonoscopy is a procedure often performed for prevention, diagnosis, and treatment of a variety of symptoms and diseases of the lower digestive tract, and sedation or anesthesia should be considered as an important tool to increase its effectiveness.
Sedation and analgesia are considered key components, as they reduce anxiety and discomfort and therefore improve the procedure tolerability and patient satisfaction, minimize risk of complications and provide better conditions for the examination.
Propofol may be used alone or in combination with opioids and/or benzodiazepines.
The use of propofol alone requires higher doses, which may lead to increased incidence of side effects. However, the risks and benefits of adding analgesic and sedative to propofol are controversial, and the selection of drugs is a crucial factor in determining the outcomes.
Clonidine apparently produces its sedative and anaesthetic-sparing effects by stimulation of centrally located alpha2 adrenoceptors. Analgesia seems to be mediated mainly by activation of alpha2 adrenoceptors in the dorsal horn of the spinal cord.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 62
- Age 18-65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Patients undergoing colonoscopy.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol combined with clonidine group Propofol combined with clonidine Patients will receive 2 μg/kg of clonidine for injection intravenously 30 min before induction of sedation, administered over 10 min. Propofol group Propofol 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.
- Primary Outcome Measures
Name Time Method Patient satisfaction 24 hours postoperatively 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).
- Secondary Outcome Measures
Name Time Method Heart rate Till the end of surgery Heart rate will be recorded at 30 minutes before induction, at induction, and at the end of surgery.
Mean arterial blood pressure Till the end of surgery Mean arterial blood pressure will be recorded at 30 minutes before induction, at induction, and at the end of surgery.
Side effects 24 hours postoperatively Side effects such as nausea and vomiting, psychological reactions will be noted.
Trial Locations
- Locations (1)
Tanta University
🇪🇬Tanta, El-Gharbia, Egypt