Additive Effects of Clonidine Used in Propofol Sedation in Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
The objective of this study was to compare safety, satisfaction, and efficiency outcomes of propofol versus propofol with clonidine in patients undergoing colonoscopy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status I-II.
- •Patients undergoing colonoscopy.
排除标准
- •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.
研究组 & 干预措施
Propofol group
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.
干预措施: Propofol (Drug)
Propofol combined with clonidine group
Patients will receive 2 μg/kg of clonidine for injection intravenously 30 min before induction of sedation, administered over 10 min.
干预措施: Propofol combined with clonidine (Drug)
结局指标
主要结局
Patient satisfaction
时间窗: 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).
次要结局
- Heart rate(Till the end of surgery)
- Mean arterial blood pressure(Till the end of surgery)
- Side effects(24 hours postoperatively)
研究者
Rabab Mohamed Mohamed Mohamed
Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University