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临床试验/CTRI/2025/07/090208
CTRI/2025/07/090208尚未招募4 期

Safety and efficacy of intrathecal hyperbaric Ropivacaine 0.75 percent vs Bupivacaine 0.5 percent in elective lower segment caesarean section A prospective randomised study

D Y Patil Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年7月31日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
160
试验地点
1
主要终点
To evaluate the effect of ropivacaine and bupivacaine on hemodynamic changes in pregnant patients undergoing caesarean section.

研究概览

简要总结

Spinal Anaesthesia with drug hyperbaric ropivacaine 0.75 percent and hyperbaric bupivacaine 0.5 percent in pregnant patient undergoing elective caesarean sections will be used. hemodynamic parameters like blood pressure and pulse rate will be assessed at every 2 minute interval till 30 minutes and then every 10 minutes till the end of surgery to compare both the drugs. Sensory and Motor blockade will also be assessed with Bromage’s scale at same time intervals.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • ASA grade 2 Gestational age between 37 to 42 weeks Giving consent.

排除标准

  • Patient height less than 150cms Spinal deformity Allergy to drug ASA grade3 and above Refused for consent.

结局指标

主要结局

To evaluate the effect of ropivacaine and bupivacaine on hemodynamic changes in pregnant patients undergoing caesarean section.

时间窗: Baseline and every 2 minutes till 30 minutes then every 10 minutes till the end of surgery

次要结局

  • To measure the onset of sensory and motor block and duration of sensory and motor blockade(Baseline and every 2 minutes till 30 minutes then every 10 minutes till the end of surgery)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Surekha patil

D Y Patil Hospital

研究点 (1)

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