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临床试验/NCT00492453
NCT00492453Unknown不适用

A Controlled Randomized Trial Comparing Spinal Versus General Anesthesia for Elective Laparoscopic Cholecystectomy in Fit Patients

University of Thessaly2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
postoperative pain

研究概览

简要总结

The purpose of the study is to assess whether spinal anesthesia is or not superior to the standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.

详细描述

Laparoscopic cholecystectomy under regional anesthesia alone has been reported only occasionally in the past; all these reports included patients unfit to receive general anesthesia, mainly patients with severe chronic obstructive airway disease. Regional anesthesia has been used for laparoscopy in fit patients almost exclusively in combination with general anesthesia, in order to extend the analgesic effect during the early postoperative period. Surprisingly, in the era of minimally invasive medicine, regional anesthesia has not gained popularity, and has not been routinely used as a sole method of anesthesia in laparoscopic procedures. It is generally accepted that all laparoscopic procedures are merely a change in access and still require general anesthetic; hence the difference from conventional surgery is likely to be small. This statement is predominantly based on the assumption that laparoscopy necessitates endotracheal intubation to prevent aspiration and respiratory embarrassment secondary to the induction of CO2 pneumoperitoneum which in turn is not well tolerated in a patient who is awake during the procedure. However, it is surprising that regional anesthesia has been successfully used for laparoscopic cholecystectomy in patients unfit to have the procedure under general anesthesia, but has not been tested in fit patients, in whom any presumed risk would be, theoretically, much lower. We have recently shown in a pilot study the feasibility to perform successfully and safely laparoscopic cholecystectomy with low pressure CO2 pneumoperitoneum under spinal anesthesia alone, in fit patients with symptomatic gallstone disease. We have also noticed that spinal anesthesia results in exceptionally minimal postoperative pain. After this pilot study, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for elective laparoscopic cholecystectomy in fit patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (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

入选标准

  • elective laparoscopic cholecystectomy
  • ASA I, II
  • normal coagulation profile

排除标准

  • acute cholecystitis / cholangitis / pancreatitis
  • previous open surgery in the upper abdomen
  • contraindication for pneumoperitoneum
  • contraindication for spinal anesthesia (ie spinal deformity)

结局指标

主要结局

postoperative pain

时间窗: 24hrs

次要结局

  • complications(30 days)
  • hospital stay(time from intervention to discharge)
  • patient satisfaction(within 2 weeks from intervention)

研究者

申办方类型
Other

研究点 (2)

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