Study of Analgesic Effect and Individual Sensitivity Differences of Opioid Analgesics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean Pressure Pain Threshold
研究概览
简要总结
Purpose: This study aimed to find a quick and timely way to investigate the individual variation of efficacy of opioid analgesic in Chinese patients undergoing elective surgeries. Methods: 120 female patients receiving elective surgery under general anesthesia were recruited into this study. At the time of routine intravenous anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect, effects on Narco-trend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system.
详细描述
Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 20-65 years
- •Anesthesiologists (ASA) physical status I or II;
- •Within ±20% of ideal body weight;
- •Agreed to participate the research
排除标准
- •History of chronic pain;
- •Psychiatric diseases;
- •Diabetes mellitus;
- •Severe cardiovascular diseases;
- •Kidney or liver diseases;
- •Alcohol or drug abuse (according to the criteria of DSM-IV);
- •Pregnancy or at lactation period;
- •Disagree to participate to the research
结局指标
主要结局
Mean Pressure Pain Threshold
时间窗: 10 minutes after the procedure
According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics
Mean Value of Narco-trend Index
时间窗: 10 minutes after the procedure
According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state.
次要结局
- Mean Arterial Pressure(10 minutes after the procedure)
- Mean Heart Rate(10 minutes after the procedure)
- Mean Respiratory Frequency(10 minutes after the procedure)
研究者
Xianwei Zhang
Professor, MD.
Huazhong University of Science and Technology