跳至主要内容
临床试验/CTRI/2025/02/080677
CTRI/2025/02/080677尚未招募4 期

Comparative study of hyperbaric ropivacaine vs hyperbaric levobupivacaine for spinal anesthesia in Caesarean section : A prospective randomized double blind clinical study

Government medical College Baroda1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
116
试验地点
1
主要终点
Pulse rate in both the groups will be compared

研究概览

简要总结

Generally, spinal anaesthesia is performed with hyperbaric racemic bupivacaine. Levobupivacaine and Ropivacaine are two new long acting local anesthetics ( pure S enantiomers of bupivacaine) that have been developed as an alternative to bupivacaine after evidence of its severe toxicity. In the present study, we would like to compare the hemodynamic stability and block characteristics of two pure S enantiomers of bupivacaine - hyperbaric Levobupivacaine (0.5%) and hyperbaric ropivacaine (0.75%) in patients undergoing elective Caesarean Section

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

  • 18-40 years
  • ASA physical status 2
  • Elective Caesarean Section
  • Singleton Full Term Pregnancy.

排除标准

  • Patient refusal
  • Patient on anti coagulant therapy
  • Patient with allergy to local anesthetics
  • Increased Intra cranial pressure
  • Severe hypovolemia
  • Height less than or equal to 150 centimetres
  • BMI greater than or equal to 30.

结局指标

主要结局

Pulse rate in both the groups will be compared

时间窗: before spinal anesthesia, immediately after spinal anestheia, every 5 minutes for the first half hour and every 15 minutes for the rest of the surgery

次要结局

  • 1. Time required to reach sensory block up to T6(2. Time required to reach Maximum (peak) level of sensory block)

研究者

发起方
Government medical College Baroda
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sreenidhi Shukla

Government Medical College, Baroda

研究点 (1)

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