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临床试验/CTRI/2024/06/069444
CTRI/2024/06/069444尚未招募4 期

Comparison of incidence of hypotension in height adjusted dose vs fixed dose of bupivacaine in spinal anesthesia in cesarean section: A randomised controlled trial

Dr SN medical college Jodhpur1 个研究点 分布在 1 个国家目标入组 50 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
50
试验地点
1
主要终点
Incidence of hypotension in height adjusted dose of 0.5% heavy bupivacaine (0.06mg/cm) in cesarean section under spinal anaesthesia compared to fixed dose 2ml(10mg) 0.5% heavy bupivacaine in cesarean section under spinal anaesthesia in control group

研究概览

简要总结

The aim of this study is to compare incidence of hypotension in one group receiving height adjusted dose of heavy bupivacaine 0.5%(0.06mg/cm) with other group receiving fixed dose of heavy bupivacaine 0.5% in parturients for cesarean section under spinal anaesthesia.

Following is also compared in each group:

Incidence of nausea and vomiting

Intraoperative fluid requirement

Cumulative dose of vasopressor used

Extent of surgical anaesthesia

Other complications if any (bradycardia,dyspnea)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Age more than 18 yrs ASA1,2 Elective cesarean section Singleton pregnancy more than 37weeks Uncomplicated pregnancy.

排除标准

  • Presenting with any systemic illness Emergent surgery and labouring parturients Multiple or twin pregnancy.

结局指标

主要结局

Incidence of hypotension in height adjusted dose of 0.5% heavy bupivacaine (0.06mg/cm) in cesarean section under spinal anaesthesia compared to fixed dose 2ml(10mg) 0.5% heavy bupivacaine in cesarean section under spinal anaesthesia in control group

时间窗: Blood pressure reading will be monitored once before spinal anaesthesia then after spinal anaesthesia every 1 min for 10 mins, every 5mins till 30 mins then every 10 mins till end of surgery.

次要结局

  • Incidence of nausea and vomiting in each group(After spinal anaesthesia till end of surgery)
  • Intraoperative fluid requirement(After spinal anaesthesia till end of surgery)
  • Cumulative dose of vasopressor(ephedrine) required(After spinal anaesthesia till the end of surgery)
  • Extent of surgical anaesthesia in each group(Time to achieve T6 level of sensory block and highest level of sensory block will be noted after administration of drug.)
  • Other complications if any(After intrathecal drug administration in each group)

研究者

发起方
Dr SN medical college Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Pratima

Dr SN Medical college, Jodhpur

研究点 (1)

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