Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries
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
- VAS ratings of pain
研究概览
简要总结
Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.
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 physical status I-II
- •Selective laparoscopic surgeries
排除标准
- •Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- •Participants younger than 18 years, older than 45 years or pregnancy was eliminated
- •Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study
- •Those who were not willing to or could not finish the whole study at any time
研究组 & 干预措施
1
Fentanyl delivered for controlling awaking pain
干预措施: Fentanyl citrate (Drug)
2
Sufentanil delivered for controlling awaking pain
干预措施: Sufentanil citrate (Drug)
3
Butorphanol delivered for controlling awaking pain
干预措施: Butorphanol tartrate (Drug)
结局指标
主要结局
VAS ratings of pain
时间窗: 0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia
次要结局
- Hemodynamics of patients(30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation)
- Sedative ratings with VAS system(0,5,10,15,25,45 and 60min after awake from anesthesia)
- Overall VAS satisfaction ratings(1 h after operation)
- Blood cortisol and β-endorphin levels(0, 10min before the end of surgeries, 10min, 1h and 6h after operation)
- Side effects(1 h after operation)