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临床试验/CTRI/2024/07/069822
CTRI/2024/07/069822尚未招募4 期

Efficacy of continuous spinal anaesthesia versus single shot spinal anaesthesia in elective lower segment cesarean section in terms of incidence and severity of hypotension

Dr Rupal Gupta1 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15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
100
试验地点
1
主要终点
Incidence of hypotension

研究概览

简要总结

The thesis title Efficacy of continuous spinal anaesthesia versus single shot spinal anaesthesia for elective lower segment cesarean section in terms of incidence and severity of hypotension. A interventional study will be conducted in the department of anaesthesiology and pain medicine, Pt. J.N.M. Medical College and DR. B.R.A.M. Hospital Raipur (C.G.) after approval from institutional scientific and ethics committee.

A total of 100 (50 patients in each group) patients under age group of 20-45 years female of ASA grade II and III and undergoing elective lower segment cesearian section with a height of 140-170cm and weight of 40-60kg will be included in this study.

All the enrolled parturients will be randomly placed into two groups to receive either continuous spinal anaesthesia (Group A) or single shot spinal anaesthesia (Group B) with the help of sealed envelope.

In CSA Group Group A, subarachnoid space will be accessed through 18 Gauge Tuoh’s epidural needle at L4-L5 interspace after getting free flow of cerebrospinal fluid, 20 gauge epidural catheter will be inserted and advanced 2cm into the subarachnoid space. Epidural needle will be removed carefully and epidural catheter will be fixed and thereafter patient will be allowed to lie supine.

After confirmation of cerebrospinal fluid through the catheter, 1 ml of 0.5% bupivacaine heavy will be injected into the subarachnoid space and flush with 0.5 ml normal saline. After 10 minutes if the sensory block level will not reach upto T4 dermatome level then 2^nd aliquot of 0.3ml of 0.5% bupivacaine heavy will be injected and flushed with 0.5 ml normal saline.

If block level not reach upto T4 dermatome level in 3 doses then it will be considered as failure.

At the end of surgery fentanyl 25mcg will be injected with a flush of 0.5ml normal saline. After completion of surgery epidural catheter will be removed.

In SSSA Group Group B subarachnoid space will be accessed through 25 gauge Quinke’s spinal needle at L4-L5 interspace. After confirmation of aspiration of cerebrospinal fluid through the needle in the syringe a 2ml of single shot 0.5% bupivacaine heavy will be injected into the subarachnoid space and needle will be removed and patient allowed to lie in supine position and check the desired T5- T6 dermatome level to proceed the surgery.

After the injection in both the groups Heart Rate, Systolic Blood Pressure, Dystolic Blood Pressure, Mean Artrial Pressure, Severity and Incidence of Hypotension to be monitered every 3 minute upto 15 minute, and every 5 minute till completion of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • ASA grade II.
  • III Age: 20-45/ female Height:140-170 cm Weight: 40-60 kg Patient undergoing elective LSCS.

排除标准

  • Refusing to be enrolled.
  • Any contraindication to spinal anaesthesia Central nervous system disorder.
  • Bleeding and coagulation disorder.
  • Cardio respiratory disorder.
  • Any spinal deformity.

结局指标

主要结局

Incidence of hypotension

时间窗: 12 hours

Severity of hypotension

时间窗: 12 hours

次要结局

  • Total dose & number of boluses of mephenteramine required to manage hypotension(Time required to achieve block height up to T4)

研究者

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

Dr Rupal Gupta

Pt J N M medical college raipur cg

研究点 (1)

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