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临床试验/CTRI/2024/12/077557
CTRI/2024/12/077557尚未招募不适用

A Prospective Randomised Comparative Study of 0.5 percent Hyperbaric Levobupivacaine with Fentanyl and 0.5 percent Hyperbaric Bupivacaine with Fentanyl for spinal anesthesia for Caesarean section.

Dr Manisha Vaghela1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年9月18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
90
试验地点
1
主要终点
To compare haemodynamic changes

研究概览

简要总结

A bolus  spinal injection of local anaesthetic drug using a suitable spinal needle - Quincke Babcock 23G, is the most popular used procedure for painless and comfortable casarean section for both patient  and the surgeon.

Although Bupivacaine is most commonly used local anesthetic agent in obstetric practice, levobupivacaine is gaining popularity that has almost same onset of sensory blockade with shorter motor blockade band more satisfactory haemodynamics and less use of inotropes intraoperatively.

The current  will compare hyperbaric levobupivacaine with fentanyl and hyperbaric bupivacaine with fentanyl for spinal anesthesia for caesarean section.. to compare haemodynamics as primary outcome.

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
20.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • 1.Valid informed and written consent 2.Pregnant mothers with height between 145-165 cms.
  • 3.Pregnant mothers with weight between 50-70kgs 4.Singleton pregnancy with term gestation for elective caserean section.

排除标准

  • 1.Patient refusal 2.Short statured mothers 3.Patients belopnging to ASA class-3.

结局指标

主要结局

To compare haemodynamic changes

时间窗: Baseline, 2min,4min, 6min, 9min,12min,15min, 30min 45min and 60min

次要结局

  • onset, duration, regression of motor & sensory block(request for analgesia)

研究者

发起方
Dr Manisha Vaghela
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Manisha vaghela

District hospital ballari

研究点 (1)

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