Ondansetron for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Overall stability of systolic blood pressure control versus baseline
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.
详细描述
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Ondansetron have been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. However, whether ondansetron could further reduction the incidence of post-spinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-40 years
- •Primipara or multipara
- •Singleton pregnancy ≥ 37 weeks
- •American Society of Anesthesiologists physical status classification I to II
- •Scheduled for elective cesarean section under spinal anesthesia
排除标准
- •Body height < 150 cm
- •Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- •Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
- •Hemoglobin < 7g/dl
- •Fetal distress, or known fetal developmental anomaly
研究组 & 干预措施
Control group
A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.
干预措施: normal saline (Drug)
Ondansetron 4 mg
A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.
干预措施: Ondansetron 4 mg (Drug)
Ondansetron 8 mg
A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.
干预措施: Ondansetron 8 mg (Drug)
结局指标
主要结局
Overall stability of systolic blood pressure control versus baseline
时间窗: 1-15 minutes after spinal anesthesia
Evaluated by performance error (PE)
The incidence of post-spinal anesthesia hypotension
时间窗: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) \< 80% of the baseline
次要结局
- pH(Immediately after delivery)
- APGAR score(5 min after delivery)
- Base excess(Immediately after delivery)
- Partial pressure of oxygen(Immediately after delivery)
- Overall stability of heart rate control versus baseline(1-15 minutes after spinal anesthesia)
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia)
- The incidence of hypertension(1-15 minutes after spinal anesthesia)
- The incidence of severe post-spinal anesthesia hypotension(1-15 minutes after spinal anesthesia)
- The incidence of bradycardia.(1-15 minutes after spinal anesthesia)