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临床试验/CTRI/2025/11/097710
CTRI/2025/11/097710尚未招募不适用

Efficacy of two doses of Intravenous Ondansetron on spinal anaesthesia induced hypotension and bradycardia in patients undergoing LSCS: A Comparative study

Sapthagiri Institute of Medical Sciences and Research Centre Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年12月15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
Incidence of hypotension SBP less than 90mmhg or morethan 20 percent decrease from baseline and bradycardia HR less than 60bpm

研究概览

简要总结

A Comparative study evaluated the efficacy of two intravenous doses of ondansetron in preventing spinal anaesthesia-induced hypotension and bradycardia in parturients undergoing elective LSCS. Ondansetron, administered before spinal anaesthesia, significantly reduced the incidence of hypotension, bradycardia, and vasopressor requirement compared to control, with no adverse maternal or neonatal effects. The higher dose showed slightly better haemodynamic stability. Ondansetron also decreased intraoperative nausea and vomiting. Thus, prophylactic ondansetron is a safe and effective measure to attenuate haemodynamic disturbances during spinal anaesthesia for caesarean section.

研究设计

研究类型
Interventional
分配方式
Na
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

  • 1 Parturients scheduled for elective cesarean section under spinal anaesthesia 2 Aged 18 to 40 years 3 ASA physical statusII 4 Written informed consent.

排除标准

  • 1 Allergy to study drugs 2 Pregnancy-induced hypertension (PIH) 3 Presence of any other comorbid conditions.

结局指标

主要结局

Incidence of hypotension SBP less than 90mmhg or morethan 20 percent decrease from baseline and bradycardia HR less than 60bpm

时间窗: Incidence of hypotension SBP less than 90mmhg or morethan 20 percent decrease from baseline and bradycardia HR less than 60bpm

次要结局

  • Vasopressor requirement and incidence of shivering(From induction of spinal anaesthesia to 120 minutes)

研究者

发起方
Sapthagiri Institute of Medical Sciences and Research Centre Department of Anaesthesia
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR Harshitha KR

Sapthagiri Institute of Medical Sciences and Research Centre

研究点 (1)

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