Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy: a Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Duration of Operation
研究概览
简要总结
The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.
Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia , postoperative complications, pain score and duration of operation time will record.
详细描述
Objective of study : The aim of this study was to compare general anesthesia (GA) and combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer several advantages over general anesthesia.
Material and methods
Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder. Intraoperative events related to combined anesthesia : abdominal discomfortable, shoulder pain, abdominal pain, nausea, anxiety, dermatomal level of sensory blockade, respiratory depression. We compare between two group; shoulder pain, postoperative complications, pain score, duration of operation time and length of hospital stay.
Fifty patients will select prospectively for LC, under low pressure (10 mm Hg) pneumoperitoneum and under combined anesthesia and general anesthesia. Spinal anaesthesia was performed at L1-L2 interspace using 2 ml of 0.5% (10 mg) hyperbaric Bupivacaine mixed with 0.5ml (25 micrograms) of Fentanyl. Epidural catheter was inserted at L1- L2 interspace too.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gall stone disease, polyp
排除标准
- •Gall bladder cancer
结局指标
主要结局
Duration of Operation
时间窗: up to 2 hours
group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes
Post-operative Shoulder Pain
时间窗: from end of the operation to postoperative 3 days
Group 1 and Group 2 Post-operative shoulder pain
次要结局
- Duration of Anaesthesia(up to 2 hours)
- Post-operative Abdominal Pain 2nd Hour(pain at postoperative 2nd hour)
- Post-operative Abdominal Pain 6th Hour(pain at postoperative 6th hour)
- Post-operative Abdominal Pain 12th Hour(pain at postoperative 12th hour)
- Headache(from end of the operation to postoperative 3 days)
- Post-operative Abdominal Pain 24th Hour(pain at postoperative 24th hour)
- Intra-operative Shoulder Pain(during operation time, up to 2 hours)
- Nausea/Vomiting(from end of the operation to postoperative 1 day)
- Post-operative Abdominal Pain 4th Hour(pain at postoperative 4th hour)
- Urinary Retention(from end of the operation to postoperative 1 day)
研究者
TURGUT DONMEZ
Medical Doctor, General Surgeon
Lütfiye Nuri Burat Government Hospital