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临床试验/NCT01361516
NCT01361516Unknown不适用

Comparison of General Anaesthesia and Sedation on the Stone Fragmentation Efficacy of the Third Generation Lithotriptor

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
试验地点
2
主要终点
Measurement of stone fragmentation during lithotripsy treatment under general anesthesia and sedation

研究概览

简要总结

The aim of the study is to compare the impact intravenous sedation versus general anesthesia on the efficacy of stone fragmentation in extracorporeal shock wave lithotripsy treatment.

详细描述

The newer lithotriptors were reported to be less efficacious than the Dornier HM3 lithotriptor; and it is not clear the reason why there is decrease in efficacy of the new lithotriptors. Is it due to their small focal point or to increased patient movement while under intravenous sedation.When the patients get sedated then it will be difficult to control their respiratory movements. Retrospective comparisons suggest that intravenous may facilitate earlier discharge if no manipulation of the airway was done; but they are often associated with pain, hypoxemic respiratory episodes and disruptive movements during lithotripsy Instead of intravenous sedation, general anesthesia offer pain free procedures, no movement of the patient and controlled movement of the respiration leads to stable position of the urinary stones and receives persistent shock wave energy on to the stone bringing about better and early fragmentation. Hence we work on the hypothesis that the new generation shock wave lithotripters have a small focal point, every movement of the stone during the respiration or patient movement, will take the stone out of the focus and there results in loss of shocks leading to lithotripsy failure and use of more fluoroscopy for refocusing the stone.

Thus we think the proper choice of anesthetic technique will improve the efficacy of stone fragmentation in shock wave lithotripsy treatment at least in those who are obese and suffers from occult sleep- apnoea syndrome

研究设计

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

入排标准

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

入选标准

  • Renal or upper ureteral stone of less than 2cm
  • A.S.A Grade 1.2.3
  • Age above 18 years

排除标准

  • Mid or lower ureteral stones
  • Bilateral renal stones
  • Multiple stones
  • Use of regional anesthesia
  • Coagulopathies (thrombocytopenia, anticoagulation drugs)
  • Suspected or documented difficult intubation
  • History of chronic opioid abuse

结局指标

主要结局

Measurement of stone fragmentation during lithotripsy treatment under general anesthesia and sedation

时间窗: One year

Stone fragmentation is measured as disappearence of the stone on flouroscopic monitoring and number of shocks utilised to break the stone during the lithotripsy treatment under general anesthesia (controlled ventilation) or with intravenous sedation(spontaneous ventilation)will be compared in this study.

次要结局

  • Anesthesia complications(One year)

研究者

申办方类型
Other

研究点 (2)

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