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临床试验/CTRI/2025/09/095213
CTRI/2025/09/095213尚未招募不适用

Block characteristics and hemodynamics changes in one minute delay before transitioning patient to supine, comparison of three different local anaesthetics in spinal anaesthesia

K S Hegde Medical Academy1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2025年10月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
153
试验地点
1
主要终点
Sensory and Motor block characteristics in terms of onset, maximum level acheived and duration of block following administration of 0.5% Bupivacaine or 0.5% Levobupivacaine or 0.75% Ropivacaine intrathecally

研究概览

简要总结

Spinal anaesthesia is commonly used for lower limb and lower abdominal surgeries, but immediate supine positioning may cause higher block spread and hemodynamic instability. This  study compares 0.5% hyperbaric bupivacaine, 0.5% hyperbaric levobupivacaine, 0.75% hyperbaric ropivacaine when patients are kept sitting for one minute before lying supine. The primary outcomes are sensory and motor block characteristics and secondary outcomes include hemodynamic changes and complications.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients who come under ASA 1 and ASA 2 Patients with height between 150-180cm Patients undergoing infraumbilical surgeries under subarachnoid block.

排除标准

  • Patients who refuse to participate in trail Patient who cannot comprehend, uncooperative patient Pregnant patients Patients who cannot sit Patients with any neurological deficits.

结局指标

主要结局

Sensory and Motor block characteristics in terms of onset, maximum level acheived and duration of block following administration of 0.5% Bupivacaine or 0.5% Levobupivacaine or 0.75% Ropivacaine intrathecally

时间窗: Sensory and Motor block level at baseline , 1 minute, 2 minutes,3 minutes, 4 minutes, 5 minutes, 6 minutes,7 minutes, 8 minutes , 9 minutes, 10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes after intrathecal administration of drug

次要结局

  • Hemodynamics changes such as changes in heart rate, blood pressure, blood oxygen saturation & complications such as requiring supplemental dose of analgesia, nausea & vomiting, inadequate spinal anaesthesia requiring either repeating intrathecal drug or converting to general anaesthesia(At time of drug given, 2 minutes,4 minutes,6 minutes,8 minutes, 10 minutes, 12 minutes,14 minutes, 16 minutes, 18 minutes, 20 minutes, 25 minutes,30 minutes,35 minutes, 40 minutes, 45 minutes,50 minutes,55 minutes,60 minutes after drug is given intrathecally)

研究者

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

Pachigolla Sri Sahiti

KS Hegde Medical Academy

研究点 (1)

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