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临床试验/CTRI/2023/11/059920
CTRI/2023/11/059920尚未招募Phase 3 4

Comparison of spinal block characteristics and intraoperative haemodynamic parameters in ten degree reverse Trendelenburg position and supine position in patients undergoing lower limb arthroscopic surgery.

Vardhman Mahavir medical college and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年11月28日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare the number of spinal segments blocked above T12 dermatomal level after administration of drug into subarachnoid space in patients undergoing lower limb surgery in ten-degree reverse Trendelenburg position and supine position.

研究概览

简要总结

This study is a prospective, interventional, comparative randomized study To compare the spinal block characteristics and intraoperative haemodynamic parameters in ten degree reverse Trendelenburg position and supine position in patients undergoing lower limb arthroscopic surgery. In supine (S) group, immediately after the administration of drug into the subarachnoid space the patient will be put into supine position with the operating table parallel to the floor. In reverse Trendelenburg (RT) group, immediately after the administration of drug into the subarachnoid space the patient will be put into supine position with the operating table tilted ten degrees upwards with respect to the floor. The level of spinal block will be assessed bilaterally in the midclavicular line using the cold touch method with an alcohol swab every 30 seconds until onset of sensory block. Maximal level of sensory block defined as number of spinal segments blocked above T12 at 20 min after administration of drug into subarachnoid space. Surgical intervention will begin after adequate level of sensory block is achieved for the surgical procedure. Patients will be monitored throughout the surgery and readings of heart rate, systolic, diastolic and mean arterial pressure and oxygen saturation will be noted at time of spinal block, at 2 mins, 5 mins ,10 mins, 20 mins and 30 mins, thereafter every 15 mins till the end of surgery. Any episode of bradycardia or hypotension will be noted and managed accordingly. Intra operative blood loss, requirement of IV fluids

and blood products will be monitored.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • 1.Patients aged 18 to 65 years 2.Belonging to American Society of Anesthesiologists (ASA) physical status class I or II 3.Undergoing lower limb surgery of expected duration less than two hours under spinal anaesthesia.

排除标准

  • 1.Patients who are pregnant 2.Obese (BMI > 30 kg/m2) 3.Height <165 cms and >180 cms 4.Known spinal anomaly 5.Local infection 6.Coagulopathies 7.On anticoagulant medication 8.Any contraindication to spinal anaesthesia.

结局指标

主要结局

To compare the number of spinal segments blocked above T12 dermatomal level after administration of drug into subarachnoid space in patients undergoing lower limb surgery in ten-degree reverse Trendelenburg position and supine position.

时间窗: To compare the number of spinal segments blocked above T12 dermatomal level at 20 mins after administration of drug into subarachnoid space in patients undergoing lower limb surgery in ten-degree reverse Trendelenburg position and supine position.

次要结局

  • 1.To compare the incidence of hypotension & vasopressor requirement.(2.To compare the time taken for regression of spinal block till T12 dermatome level.)

研究者

发起方
Vardhman Mahavir medical college and Safdarjung Hospital
申办方类型
Government medical college

研究点 (1)

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