Reduction in Spinal-induced Hypotension With Ondansetron in Parturients Undergoing Caesarean Section: A Double-blind Randomised, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Hypotension
研究概览
简要总结
Subarachnoid block is the preferred method of anaesthesia for caesarean section, but is associated with hypotension and bradycardia, which may be deleterious to both parturient and baby. Animal studies suggest that in the presence of decreased blood volume, 5-HT may be an important factor inducing the Bezold Jarisch reflex via 5-HT3 receptors located in intracardiac vagal nerve endings. In this study, the investigators evaluated the effect of ondansetron, as a 5-HT3 receptor antagonist, on the haemodynamic response following subarachnoid block in parturients undergoing elective caesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing an elective lower segment caesarean section.
排除标准
- •Patients with contraindications to subarachnoid block (patient refusal, unstable haemodynamics, coagulation abnormality),
- •History of hypersensitivity to ondansetron or local anaesthetic agents,
- •Hypertensive disorders of pregnancy,
- •Cardiovascular insufficiency,
- •Receiving selective serotonin reuptake inhibitors or migraine medications.
研究组 & 干预措施
Ondansetron
Intravenous Ondansetron 4 mg diluted in 10 mL of normal saline over 1 min, 5 min before spinal anaesthesia
干预措施: Ondansetron (Drug)
control
Normal Saline 10 mL over 1 min, 5 min before spinal anaesthesia
干预措施: Normal saline (Drug)
结局指标
主要结局
Hypotension
时间窗: intraoperative
Systolic BP \<90 mmHg or Diastolic BP \<60 mmHg
次要结局
- Bradycardia(intraoperative)
研究者
Mostafa Samy Abbas
lecturer of anesthesia and ICU, Assiut University,Assiut, Egypt
Assiut University