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临床试验/CTRI/2025/08/093696
CTRI/2025/08/093696尚未招募不适用

Comparison of limb occlusion pressure determined by ultrasound doppler versus the conventional technique for lower limb surgeries under tourniquet: A Randomized controlled study

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2025年9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
38
试验地点
1
主要终点
Mean limb occlusion pressure to achieve a hemostasis score of less than 4

研究概览

简要总结

Double blind, Randomized controlled study of 38 patients undergoing tourniquet assisted lower limb surgeries under central neuraxial block. This study compares the 2 groups for limb occlusion pressure. Group UG determines limb occlusion pressure by using ultrasound doppler and Group SG in which limb occlusion pressure is set according to the preoperative systolic blood pressure. Primary outcome is the mean limb occlusion pressure to achieve hemostasis score of less than 4. Secondary outcomes are Intraoperative hemostasis score, Tourniquet related complications at 6, 12, 24, 48 hours, Limb circumference measurement at 24 hours and 48 hours., Surgeon’s satisfaction score at 24 hours post operatively and Quality of recovery at 48 hours post operatively.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 to 70 years with American Society of Anesthesiologists (ASA) physical status I to III.

排除标准

  • Peripheral vascular conditions including varicose veins and arterial occlusive vasculitis, History of deep vein thrombosis in last 3 months, Hematological disorders such as sickle cell anemia and Patients taking Antiplatelet drugs preoperatively.

结局指标

主要结局

Mean limb occlusion pressure to achieve a hemostasis score of less than 4

时间窗: Pre operatively measured i.e. Baseline

次要结局

  • Intraoperative hemostasis score
  • Tourniquet related complications(6,12,24,48 hours after surgery)
  • Limb circumference measurement(24 and 48 hours after surgery)
  • Surgeons satisfaction score(24 hours post operatively)
  • Quality of recovery(48 hours post operative)

研究者

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

Garima Singh

Maulana Azad Medical College

研究点 (1)

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