跳至主要内容
临床试验/CTRI/2024/01/062119
CTRI/2024/01/062119尚未招募不适用

A randomised comparative study for the efficacy of 0.5% hyperbaric Levo bupivacaine versus 0.75% hyperbaric ropivacaine in parturients undergoing lower segment caesarean section under spinal anaesthesia

SMS Medical College and hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年2月5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
96
试验地点
1
主要终点
To assess and compare mean time of onset of sensory and motor blockade between the study groups,level of sensory blockade at different time intervals until the highest level achieved,time duration of sensory and motor block,requirement of first rescue analgesia in post operative period between the study groups.

研究概览

简要总结

In this study we will compare the efficacy of hyperbaric bupivacaine and hyperbaric ropivacaine in parturients undergoing LSCS under spinal anaesthesia and requirement of first rescue analgesia.

In this study we will assess and compare mean time onset of sensory and motor blockade , level  of sensory blockade at different time intervals until highest level achieved,time duration of sensory and motor block,requirement of first dose of rescue analgesia in post operative period,hemodynamic variables (pulse rate,SBP,DBP,MAPAND SPO2) at different time intervals.

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 40.00 Year(s)(—)
性别
Female

入选标准

  • Parturients willing to participate in the study undergoing LSCS under subarachnoid block with age group of 18 to 40 years and ASA grade II.

排除标准

  • Parturient should not be a part of other study,non co-operative parturient,history of allergy or hypersensitivity to any drug of study,any deformity or local sepsis in spinal lumbar region,severe hypovolemia,any bleeding or coagulation abnormalities,parturients receiving tranquillisers,phenothiazines or other CNS depressants including alcohol,any major pre-existing comorbidities such as COPD,neurological,cardiovascular,metabolic,hepatic,respiratory or renal disease.

结局指标

主要结局

To assess and compare mean time of onset of sensory and motor blockade between the study groups,level of sensory blockade at different time intervals until the highest level achieved,time duration of sensory and motor block,requirement of first rescue analgesia in post operative period between the study groups.

时间窗: 1,2,3,5,10,15,20,25,30,40,50,60 minutes

次要结局

  • To assess and compare hemodynamic variables at different time intervals such as SBP,DBP,MAP and SPO2,frequency of side effects if any(1,2,3,5,10,15,20,25,30,40,50,60 minutes)

研究者

发起方
SMS Medical College and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Chandrashekhar Chatterjee

Sawai man Singh medical college, Jaipur

研究点 (1)

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