Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft: Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The incidence of postoperative shivering
研究概览
简要总结
This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG.
详细描述
Shivering is a common complication in the postoperative period. The incidence of shivering has been reported to range from 5% to 65% under general anesthesia and as 33% during epidural anesthesia. Shivering can increase perioperative risk in patients. Both dexmedetomidine and meperidine are effective agents for the prevention of postanesthetic shivering. However, few studies have compared the anti-shivering effects of different agents following coronary artery bypass graft (CABG). This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged between 18 and 75 years, (2) undergoing elective CABG, (3) ASA grade of II-IV, and (4) in accordance with ethical guidelines, patients must voluntarily participate in the trial and sign the informed consent for the clinical study.
排除标准
- •(1) patients with neurological or psychiatric disorders, (2) hepatic and renal dysfunction, (3) severe hyperthyroidism or hypothyroidism, (4) a body temperature greater than 38 °C or less than 36 °C, (5) postoperative hemodynamic instability, (6) preoperative use of a left ventricular assistance device, (7) pa severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, diabetic nephropathy), (8) participation in other clinical studies within the past 3 months, (9) acute or chronic pain, (10) addiction to opioids, (11) drug abuse, (12) pain management, and (13) neuromuscular disease, (14) on-pump CABG.
研究组 & 干预措施
Control group
干预措施: Placeb (Drug)
Dexmedetomidine group
干预措施: Dexmedetomidine (Drug)
Meperidine group
干预措施: Meperidine (Drug)
结局指标
主要结局
The incidence of postoperative shivering
时间窗: Within postoperative 24 hours
The incidence and severity of postoperative shivering and the rescue treatment
次要结局
- Times of postoperative rescue drugs used(Within postoperative 24 hours)
- The incidence of postoperative hypotension and bradycardia(From the administration of experimental drugs to postoperative 24 hours)
- Length of stay in the ICU(The length of stay in ICU within postoperative 30 days)
- The incidence and severity of postoperative PONV(Within postoperative 3 days)
- The incidence of postoperative arrhythmias(Within postoperative 24 hours)
- Length of stay(The first day after surgery to discharge)
- The rate of all-cause death of participants(Within postoperative 30 days)
- Ramsay sedation score(Within postoperative 3 days)
- Postoperative extubation time(The time of extubation)
- The incidence of postoperative delirium(Within postoperative 7 days)
研究者
Lili Cao
Professor
Qianfoshan Hospital