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临床试验/CTRI/2024/07/070663
CTRI/2024/07/070663招募中2 期

Comparison Of Effects Of Trendelenburg 20 Degree, Passive Leg Raising At 45 Degree And Supine Position On The Hemodynamic Changes After Tourniquet Deflation In Orthopaedic Lower Limb Surgery Under Spinal Anaesthesia - A Prospective Parallel Controlled Study

Deen Dayal Upadhyay Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月26日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
90
试验地点
1
主要终点
to evaluate the effect of tredenlenberg 20 degree position,passive leg raise at 45 degree and supine position on mean arterial pressure and heart rate after 5 minutes of torniquet deflation

研究概览

简要总结

It is a Prospective Parallel Controlled Study to Compare the effect of Trendelenburg 20 degree position, Passive leg raising at 45 degree and Supine position on hemodynamic changes after tourniquet deflation in patients undergoing Orthopaedic lower limb surgery under Spinal Anaesthesia. Here patients will be allocated into 3 study group by block randomisation with sealed envelope system. We will prepare fifteen randomly generated treatment allocations within sealed opaque envelopes assigning T, P and C in 5 envelopes each, where T represents Trendelenburg 20degree group, P represents PLR 45 degree group and C represents control group with supine position. Once a patient will consent to enter a trial, an envelope will be opened and the patient will then be offered the allocated group. In this technique, patients will be randomised in a series of blocks of fifteen.After whic hemodynamic parameters will be monitored and recorded at baseline,0,1,2,3,4,5,10,20,30 minutes and need of vasopressors and IV fluid usuage, Torniquet inflation and Deflation time will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • ASA(American society of Anaesthesiologist) Physical status grade I/II
  • Age from 18 to 60 years and All sexes
  • Patients undergoing Orthopaedics lower limb surgeries along with use of torniquet under spinal anaesthesia
  • Patients undergoing Orthopaedics lower limb surgeries whose duration of surgery is more than 1 hour.

排除标准

  • Patients with any history of cardiovascular illness
  • Patients requiring bilateral lower limb surgery
  • Any allergy to local anaesthetic drugs
  • Any contraindication for spinal anesthesia
  • Patients undergoing lower limb vascular surgeries
  • Surgeries exceeding allowable tourniquet time
  • Intraoperative hemodynamic instability.

结局指标

主要结局

to evaluate the effect of tredenlenberg 20 degree position,passive leg raise at 45 degree and supine position on mean arterial pressure and heart rate after 5 minutes of torniquet deflation

时间窗: to evaluate the effect of tredenlenberg 20 degree position,passive leg raise at 45 degree and supine position on mean arterial pressure and heart rate after 5 minutes of torniquet deflation

次要结局

  • To compare(1. Systolic Blood Pressure (SBP) among Trendelenburg 20 degree position, Passive leg raising at 45 degree & supine position after tourniquet deflation.)

研究者

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

Dr Upasana Goswami

Deen Dayal Upadhyay Hospital

研究点 (1)

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