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.
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
Kenjom padu
Tomo riba institute of health and medical sciences
