Does Prophylactic Ondansetron Reduce Norepinephrine Consumption in Patients Undergoing Caesarean Section With Spinal Anesthesia?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Norepinephrine consumption
研究概览
简要总结
This study evaluates the effect of prophylactic ondansetron on the incidence of spinal hypotension and vasopressor consumption in caesarean section patients using norepinephrine treatment. Half of participants receive ondansetron before spinal anesthesia while the other half receive saline.
详细描述
Spinal hypotension in cesarean section patients can occur vigorously and may lead to cardiovascular collapse. If doesn't treated precipitously, It can cause maternal hypotension, nausea and vomiting and fetal acidosis. Recently norepinephrine has been proposed for the prevention and treatment of spinal hypotension with less tendency to decrease HR and CO. It has been reported that ondansetron can be used for prophylaxis and treatment of nausea and vomiting, may also reduce the vasopressor requirement in patients undergoing caesarean section with spinal anesthesia. The aim of the present study is to assess the effect of prophylactic ondansetron on norepinephrine consumption and incidence of spinal hypotension, and side effects such as maternal nausea, vomiting and bradycardia.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA physical status I-II patients
- •Between the ages of 18 and 40 years
- •Scheduled for elective caesarean section with spinal anesthesia
排除标准
- •History of hypertension
- •History of severe hepato-renal disease,
- •sensitivity or contraindication to ondansetron,
- •Drug or alcohol abuse
- •Contraindication to regional anesthesia.
研究组 & 干预措施
Ondansetron
干预措施: Ondansetron (Drug)
Saline
干预措施: Saline (Drug)
结局指标
主要结局
Norepinephrine consumption
时间窗: During the cesarean operation
Whenever systolic arteriel pressure falls below 100 mmHg or below 20% of the preoperative baseline value in both groups norepinephrine (5 µg) will be administered intravenously and total consumption will be recorded.
次要结局
- Bradicardia(During the cesarean operation)
研究者
Feride Karacaer
Specialist doctor
Cukurova University