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临床试验/CTRI/2024/02/062572
CTRI/2024/02/062572已完成4 期

Comparison of thoracic segmental spinal anaesthesia with standard general anaesthesia in open cholecystectomy: A Parallel Arm Randomized Clinical Trial

Uttar Pradesh University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年2月19日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
46
试验地点
1
主要终点
Hemodynamic parameters

研究概览

简要总结

Regional anesthesia is considered a favorable modality with significant potential in selected patients and is becoming more popular day by day . Regional anesthesia techniques can attenuate surgical stress response and provide better analgesia with reduction in postoperative opioid consumption.

This study aims to compare Thoracic Segmental Spinal Anaesthesia and Spinal Anaesthesia in patients undergoing open Cholecystectomy.

The patients will be divided into 2 groups of 23 each.

Group A: Patients who will receive Thoracic Segmental Spinal Anaesthesia with 0.75%  isobaric Ropivacaine in a dose of 1ml + 20µg of fentanyl

Group B: Patients who receive Standard General Anaesthesia

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I and II
  • Patients with body mass index between 18-
  • Patients undergoing open cholecystectomy.

排除标准

  • Patient refusal
  • Any contraindication to spinal anaesthesia
  • Patient having allergy with any of the drugs used in the study.
  • Patients with physical or mental problems leading to inability to comprehend scoring system to be employed.
  • Opioid tolerance or dependence.

结局指标

主要结局

Hemodynamic parameters

时间窗: 5, 10, 15, 30, 45 and 60min

次要结局

  • Patient satisfaction measured by 5-point Likert scale.(after 6hrs of surgery.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shuchi Nigam

Uttar Pradesh University of Medical Sciences, Saifai

研究点 (1)

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