Comparison of Postoperative Pain of Sevoflurane, Propofol, and Sevoflurane Plus Propofol in Maintenance of Anaesthesia for Gynaecological Laparoscopic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Post operative pain determined by NRS at 0.5h after surgery
研究概览
简要总结
Postoperative pain may be affected by general anaesthetics. The effect of propofol and sevoflurane on postoperative pain in chinese female patients has not been demonstrated before. This study compared the postoperative pain score in patients under general anaesthesia maintained with propofol,sevoflurane, or sevoflurane+propofol.
详细描述
After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of female patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I or II, suffering from infertilities, and undergoing selective gynaecological laparoscopic and hysteroscopic surgery. All the patients were randomly assigned to receive propofol,sevoflurane,or sevoflurane+propofol for anaesthesia maintenance. The primary outcome measure was the level of postoperative pain assessed by Numerical Analogue Scale (NAS) at rest 0.5 hour after the operation. The secondary outcomes were postoperative pain assessed by Numerical Analogue Scale (NAS) at rest 1 and 24 hour after the operation, the incidence of postoperative nausea and vomiting, the incidence of shiver, and quality of recovery determined by QOR40 in the first 24 h after surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status class 1 or 2
- •Aged >=18 years and =<40 years old
- •Suffering from infertilities
- •Under elective gynaecological laparoscopic and hysteroscopic surgery
排除标准
- •ASA-PS>=III
- •Aged under 18 yrs or above 40 yrs old
- •Body mass index (BMI) >30
- •Respiratory or Neurologic disease
- •Chronic antidepressants and Anticonvulsant drugs
- •Chronic analgesics intake
- •A known allergy to the drugs being used
- •History of substance abuse
- •Participating in the investigation of another experimental agent
- •Participating in the investigation of another study
研究组 & 干预措施
Propofol
anesthesia maintenance with propofol and remifentanil
干预措施: Propofol for maintenance (Drug)
Sevoflurane
Sevoflurane and Remifentanil for anesthesia maintenance
干预措施: Sevoflurane (Drug)
Sevoflurane+Propofol
Sevoflurane+Propofol for anesthesia maintenance
干预措施: Sevoflurane+Propofol (Drug)
结局指标
主要结局
Post operative pain determined by NRS at 0.5h after surgery
时间窗: at 0.5h after the surgery
The level of postoperative pain was assessed by Numerical Analogue Scale (NAS) at rest at 0.5 hour after the surgery.
次要结局
- Postoperative delirium(24 hours postoperatively)
- PONV(24 hours postoperatively)
- QOR(24 hours post operatively)
- Post operative pain determined by NRS at 1h and 24h after surgery(at 1h and 24h after surgery)
- Incidence of shivering in the first postoperative day.(follow up at 24 h after the surgery)
研究者
Wei Mei
Associate Professor
Huazhong University of Science and Technology