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临床试验/CTRI/2025/08/093209
CTRI/2025/08/093209尚未招募4 期

Comparison of the effect of different doses of ondansetron on spinal anesthesia induced hypotension in lower segment caesarean section: A double blinded randomized controlled study.

Department of anesthesiology TRIHMS1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年9月1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
180
试验地点
1
主要终点
To determine effect of different doses of ondansetron in reducing incidence of spinal anesthesia induced hypotension during cesarean section.

研究概览

简要总结

Subarachnoid block (spinal anesthesia) is the preferred anesthetic technique for elective lower segment cesarean section (LSCS) due to its rapid onset, reliability, and safety profile. However, it is frequently associated with significant hemodynamic disturbances, primarily hypotension and bradycardia, resulting from sympathetic blockade and decreased venous return.  These changes can adversely affect both maternal and fetal outcomes by reducing uteroplacental perfusion. Ondansetron, a selective 5-HT3 receptor antagonist commonly used as an antiemetic, has been shown to modulate the Bezold–Jarisch reflex-a vagally mediated cardiovascular reflex implicated in spinal anesthesia-induced hypotension and bradycardia . Some  studies suggest that intravenous ondansetron administered prior to spinal anesthesia at different time interval has shown a variable hemodynamic changes, reducing the incidence and severity of hypotension and bradycardia in patients undergoing cesarean section. The onset of sympathectomy after spinal anaesthesia and onset of intravenous ondansetron are almost similar that is 1-5 minutes and its peak effect around 10-15 minutes. Therefore, we will be conducting study to assess haemodynamic changes with simultaneous administration of intraveneous ondansetron during subarachnoid block.

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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • surgery under spinal anaesthesia.
  • elective lower section caesarian section.
  • ASA physical status II.

排除标准

  • patient refusal
  • multiple pregnancy.
  • history of drug allergy
  • with history of cardiac disease.
  • presented with PIH and Gestational diabetes.

结局指标

主要结局

To determine effect of different doses of ondansetron in reducing incidence of spinal anesthesia induced hypotension during cesarean section.

时间窗: Baseline, every 5 minutes till closure of abdominal wound

次要结局

未报告次要终点

研究者

发起方
Department of anesthesiology TRIHMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Kenjom padu

Tomo riba institute of health and medical sciences

研究点 (1)

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