Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery: a Randomised Non-inferiority Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Core temperature change
研究概览
简要总结
It is not known which is better for intraoperative temperature protection, warming matress or preoperative oral functional drinks in elective cesarean section. We plan to conduct a non inferiority randomized trial to clarify this problem.
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
- None
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
- •Women pregnant with a single fetus;
- •American Society of Anesthesiologists (ASA) physical status II;
- •Willingness to undergo elective cesarean delivery under CSEA;
- •An age of 20-40 years;
- •A body mass index (BMI) of 19-30 kg·m-2;
- •A gestational age of 38-40 weeks.
排除标准
- •Contraindications for CSEA;
- •A diagnosis of delayed gastric emptying, hyperemesis gravidarum until late pregnancy, or consumption of drugs that affect gastrointestinal motility within 3 days before surgery;
- •Preoperative body temperature >38°C or <36°C or the use of drugs that affect body temperature;
- •Pregnancy combined with diabetes, hypertension, or metabolic disorders (eg, hypothyroidism or hyperthyroidism);
- •Ear diseases (eg, otitis media, tympanic membrane perforation, etc) affecting measurement of ear temperature .
- •Patients who were simultaneously undergoing other operations (eg, removal of uterine fibroids and ovarian cysts) or had a surgical time >1.5 hours;
- •Patients with blood transfusion or autologous blood transfusion intraoperatively;
- •Patients who did not receive the anesthetic specified in the protocol;
- •Patients who failed to drink adequate energy drinks as prescribed before surgery.
研究组 & 干预措施
warming matress group
From the end of anesthesia, warming matriss at 40 ℃ was used for insulation until the end of surgery.
干预措施: Warming matress (Device)
oral functional drinks group
Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.
干预措施: Oral energy drinks (Other)
结局指标
主要结局
Core temperature change
时间窗: Before the operation, and every 10 minutes during the operation until the end of the operation.
The minimum value of intraoperative ear temperature minus the preoperative baseline ear temperature.
次要结局
- The incidence of nausea in pregnant women(Intraoperative)
- hypotension(Intraoperative)
- Umbilical artery blood base excess(30sec after delivery)
- Skin temperature changes(Before the operation, and every 10 minutes during the operation until the end of the operation.)
- The incidence of vomiting in pregnant women(Intraoperative)
- The incidence of shivering in pregnant women(Intraoperative)
研究者
Yi Feng, MD
Head of anesthesiology
Peking University People's Hospital