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临床试验/NCT02878512
NCT02878512已完成4 期

Comparative Evaluation of General Anesthesia (SEA) Using 0.5% Bupivacaine and Segmental Epidural Anesthesia (GA) for Percutaneous Nephro Lithotomy - A Retrospective Analysis

Maharashtra University of Health Sciences0 个研究点目标入组 60 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
60
主要终点
Hemodynamic parameters; change in Mean arterial pressures in mm Hg from baseline

研究概览

简要总结

Management of nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive endoscopic technique and is used for the fragmentation and removal of stones of size more than 20 to 30 mm, staghorn stones or multiple stones resistant to ESWL. Anaesthesia for PCNL is a challenge because of the disease, surgical procedure, positioning, hypothermia,and the possibility of fluid absorption, dilutional anaemia and blood loss. General anaesthesia is the gold standard for this surgery.The advent of new drugs has refined the technique of general anaesthesia. However there are several issues related to prone position still to be addressed like accidental extubation and difficult reintubation, nerve injuries and post operative respiratory complications.

Combined spinal epidural(CSE) and only epidural anaesthesia (EA) is a well established technique of anaesthesia for upper abdomen and lower thoracic surgeries. It use has also been reported in PCNL surgeries.Segmental epidural can selectively blocks pain fibres from the surgical site. This not only allows to limit the dose of the local anaesthetics, but also limit motor and sympathetic blockade. Selective sympathetic block is associated with respiratory, cardiac, gastrointestinal and metabolic benefits. This formed the basis of our current study. In the present study the investigators aimed to evaluate the efficacy of segmental epidural for PCNL and compared it with standard technique i.e. GA.

详细描述

To evaluate efficacy the investigators compared intraoperative haemodynamics, surgical clearance of stones, post operative pain, surgeon's and Patient's satisfaction scores and postoperative complications and side effects in 60 ASA I and II patients undergoing PCNL surgery who received either General anesthesia or Segmental epidural Anesthesia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age - 18 years to 60 years
  • Either sex
  • BMI < 30

排除标准

  • Unwilling for consent
  • Obesity with BMI >
  • Contraindications for Epidural Anaesthesia
  • Undilated pelvicalyceal system

结局指标

主要结局

Hemodynamic parameters; change in Mean arterial pressures in mm Hg from baseline

时间窗: Hemodynamic parameters Change in Mean Arterial Pressure in mm Hg Every 15 minutes for 2 hours and then every hourly till 24 hours

change in mean arterial pressure from baseline

Hemodynamic parameters: Change in heart rate per minute from baseline

时间窗: Every 15 minutes for 2 hours and then every hourly till 24 hours

Change in heart rate per minute from baseline

Postoperative Pain using VAS

时间窗: Postoperatively every hourly for 24 hours

Post operative pain was studied using VAS

次要结局

  • Surgeon satisfaction score(10 minutes Postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shakuntala Basantwani

Associate Professor

Maharashtra University of Health Sciences

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