The Preventive Effect of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The presence of nausea and vomiting
研究概览
简要总结
This is a randomized, placebo-controlled trail, the objective of this study is observation the effect of sub hypnotic dose of propofol for prevention of nausea and vomiting induced by hemabate during spinal anesthesia for elective cesarean section. The primary outcome is the presence of post-delivery intra-operative nausea and vomiting in parturients. The patients demographic characteristics, blood pressure, sensory block level, and the medications will be collected.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20-40 years;
- •American Standards Association status I-II.
排除标准
- •Patients with allergy or hypersensitivity to propofol, lipid emulsion, or granisetron;
- •History of nausea or vomiting within 24h before cesarean delivery;
- •History of gastrointestinal or psychiatric disease, motion sickness, smoking, postoperative nausea and vomiting;
- •Morbid obesity;
- •Consumption of drugs such as opioids, antiemetics , H2 antagonists, phenothiazines and/or corticosteroids within 24h before the study period;
- •Any chronic medical or surgical disorders complicating the pregnancy;
- •Conditions contraindicating regional anesthesia.
研究组 & 干预措施
propofol group
first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump
干预措施: Propofol (Drug)
control group
first dose 0.03ml/Kg normal saline, then 0.1ml/Kg/hr micro-pump
干预措施: Normal saline (Drug)
结局指标
主要结局
The presence of nausea and vomiting
时间窗: 24 hours
the patients were not asked directly about nausea during the course of the surgery, but its incidence was recorded when spontaneously reported vomiting was recorded as observed by investigator
次要结局
未报告次要终点
研究者
Yanmei-Bi
Principal Investigator
West China Second University Hospital