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临床试验/CTRI/2024/02/063036
CTRI/2024/02/063036尚未招募不适用

Clinical efficacy and safety of intrathecal anaesthesia for percutaneous nephrolithotomy - A prospective observational study

Sri Venkateswara Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Intraoperative hemodynamic stability will be assessed by observing the number of

研究概览

简要总结

We will be evaluating the clinical efficacy and safety of intrathecal anaesthesia in patients undergoing percutaneous nephrolithotomy in our institution. We will be recruiting 100 consecutive patients of age greater than 18 years and will be administering spinal anaesthesia. Following this we will be monitoring vitals throughout the procedure. We will also make a note of patient’s discomfort, satisfaction, any injuries to lung and pleura during the follow up postoperatively.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All adult patients above 18 years scheduled for elective PCNL.

排除标准

  • Patients who are not willing to participate in the study.
  • Patients with general contraindications to Spinal anesthesia.
  • Pregnant women and lactating mothers.

结局指标

主要结局

Intraoperative hemodynamic stability will be assessed by observing the number of

时间窗: At baseline, during the procedure, before shifting to recovery room

episodes of hypotension (systolic blood pressure below 90 mmhg), hypertension (systolic

时间窗: At baseline, during the procedure, before shifting to recovery room

blood pressure more than 20% from baseline), bradycardia (absolute decrease in heart

时间窗: At baseline, during the procedure, before shifting to recovery room

rate below 60 beats per minute) and tachycardia (heart rate more than 100 beats per

时间窗: At baseline, during the procedure, before shifting to recovery room

minute).

时间窗: At baseline, during the procedure, before shifting to recovery room

次要结局

  • (1) To find out conversion rate to general anaesthesia or supplementation to spinal anaesthesia((2) To find out patient discomfort at the end of surgery (before making the patient supine from prone position) on a likert type scale for discomfort)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Aloka Samantaray

Sri Venkateswara Institute of Medical Sciences

研究点 (1)

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