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临床试验/CTRI/2025/10/096092
CTRI/2025/10/096092尚未招募不适用

COMPARISON OF GRADUAL AND RAPID TOURNIQUET DEFLATION ON INTRACRANIAL PRESSURE MEASURED BY OPTIC NERVE SHEATH DIAMETER IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERY UNDER SPINAL ANAESTHESIA

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: 2025年10月30日最近更新:

试验速览

阶段
不适用
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 effect of rapid and gradual tourniquet deflation on increase in intracranial pressure changes,measured by optic nerve sheath diameter in patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia.

研究概览

简要总结

This is a prospective, comparative, randomized and interventional study comparing gradual and rapid tourniquet deflation on intracranial pressure measured by optic nerve sheath diameter in patient undergoing lower limb orthopaedic surgery under spinal anaesthesia.The primary outcome  will be calculated by increase in intracranial pressure change measured by ultrasound assessment of ONSD and also end tidal CO2 and blood pressure and heart rate

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

  • Adult patient (18-65 years) ASA GRADE 1/2 UNDERGOING ELECTIVE LOWER LIMB ORTHOPEDIC SURGERIES USING TOURNIQUET UNDER SPINAL ANAESTHESIA.

排除标准

  • Patients with pre-existing neurological disorder such as brain tumour, hydrocephalus etc.
  • Cardiopulmonary disease influencing cerebral haemodyanamic such as uncontrolled hypertension, heart failure etc.
  • Patients with eye disease: external trauma to eye, optic neuritis, optic nerve trauma, previous eye surgery 4.Coagulopathy or patient on anticoagulant therapy, local site infection contraindicating spinal anaesthesia.

结局指标

主要结局

To compare the effect of rapid and gradual tourniquet deflation on increase in intracranial pressure changes,measured by optic nerve sheath diameter in patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia.

时间窗: ONSD measurement at 15 minutes before spinal anaesthesia,before tourniquet deflation, and at 1 min 5 min 10 min and 15 min after deflation

次要结局

  • To compare the effect of rapid & gradual tourniquet deflation on end tidal CO2 in patient undergoing lower limb orthopedic surgery under spinal anaesthesia(Before tourniquet deflation, 1 min, 5 mins, 10 mins & 15 mins after deflation)
  • Effect of rapid & gradual tourniquet deflation on blood pressure (SBP,DBP,MAP) & heart rate(Before spinal anaesthesia, at 1 min, 5 mins,10 mins,15 mins after tourniquet deflation)

研究者

发起方
Vardhman Mahavir Medical College and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Subhajit Gayen

Vardhman Mahavir Medical College and Safdarjung Hospital

研究点 (1)

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