Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Intraoperative awareness
研究概览
简要总结
Uterine curettage is usually performed under the anesthesia of propofol-fentanyl or para-cervical block,of which generally has significant incidence of respiratory depression which increases the demand on intraoperative monitoring, or has unavoidable insufficient blockade which results in intraoperative suffering of pain. Butorphanol is an analgesic with combined effects on mu and kappa opioid receptors leading to a role as analgesia and sedation. The investigators hypothesized that combined propofol with butorphanol during uterine curettage would produce optimal effectiveness of these two drugs by adding sedative and analgesic effects together. In addition, it would decrease the intraoperative consumption of propofol without increase the incidence of side effects. Furthermore, such combination would alleviate postoperative pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA status I-II;
- •Performing abortion operation (medical- or drug-induced);
- •Requiring painless abortion;
排除标准
- •< 19yrs, and >= 45yrs;
- •History of central active drugs administration;
- •Drug abuse;
- •Hypertension;
- •Diabetes;
- •Any other chronic diseases;
- •Allergy to the study drugs;
- •Habit of over-volume alcohol drinking;
- •Records of history of centrally active drug use and psychiatry;
- •Any organic disorders.
研究组 & 干预措施
1
Propofol-fentanyl combined anesthesia
干预措施: Fentanyl Citrate (Drug)
2
Propofol-butorphanol combined anesthesia
干预措施: Butorphanol Tartrate (Drug)
结局指标
主要结局
Intraoperative awareness
时间窗: During the whole process of anesthesia
次要结局
- Bispectral Index (BIS) value(During the whole process of anesthesia)
- Anesthetic consumptions(From the start of operation to the end of surgical procedures)
- Postoperative pain(Since the end of the operation to 48 h follow-up.)
- Postoperative bleeding(Since the end of operation to 48 h follow-up)