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临床试验/CTRI/2024/07/070609
CTRI/2024/07/070609尚未招募2/3 期

comparison of intrathecal hyperbaric levobupivacaine and hyperbaric ropivacaine in elective caesarean section: A randomized controlled double blinded study

All India Institute of Medical Sciences Raebarel1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月25日最近更新:
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试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1.To compare onset, regression and duration of sensory block between the groups
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, double blind trial comparing efficacy of intrathecal hyperbaric levobupivacaine and hyperbaric ropivacaine in patients planned for elective caesarean section at AIIMS, Raebareli. The primary outcome is to compare onset, regression and duration of sensory and motor block and hemodynamic differences between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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

  • •1.Elective caesarean delivery, having a gestational age of more than 37 weeks, 2.ASA Class I or II.
  • •3.BMI of 18-30.

排除标准

  • •1.Refuse regional anaesthesia 2.Individuals with spinal deformity or known hypersensitivity to local anaesthetics 3.Those with placental or fetal abnormalities 4.Individuals with a body weight exceeding 100 kg, 5.Individuals with extreme heights (less than 150 cm or more than 180 cm) 6.Individuals with gestational or pregnancy-induced hypertension,.

结局指标

主要结局

1.To compare onset, regression and duration of sensory block between the groups

时间窗: 24hrs

2.To compare onset, regression and duration of motor block between the groups

时间窗: 24hrs

3.To compare duration of analgesisa between the groups

时间窗: 24hrs

次要结局

  • To compare hemodynamic effects between the groups(24 hrs)

研究者

发起方
All India Institute of Medical Sciences Raebarel
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Surendra Kumar Jangid

All India Institute of Medical Sciences

研究点 (1)

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