ED50 of Sufentanil with Dexmedetomidine Analgesia During Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The rate of the IOC2 target a reachment
研究概览
简要总结
- Sufentanil as an strong analgesic is used widespreadly during laparoscopic cholecystectomy.
- Lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect.
- The investigator are planning use the most classical method for determining the ED50 or half effective concentration of sufentanil facilitated with dexmedetomidine using sequential method, which is also called" up and down method" and" ladder method".
详细描述
The concordance of the current research is that lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect through operation. However, the dosages of sufentanil used in various researches vary greatly of operations. Previous studies have shown that the amount of sufentanil required for intraoperative analgesia is smaller than that required while dexmedetomindine facilitated. Although the appropriate dosage of sufentanil required for operation can ensure the analgesic effect of operation, excessive dosage can cause severe choking during intubation, postoperative nausea and vomiting, hyperalgesia, and chronic postoperative pain. The investigator planning use the most classical method for determining the ED50 or half effective concentration of sufentainl combined with dexmedetomidine using sequential method, which is also called " up and down method" and " ladder method".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I ~ II level;
- •BMI22-30kg/m2;
- •Those who intend to undergo laparoscopic cholecystectomy;
- •Age 18~65 years.
排除标准
- •Has been allergic to the drugs used in this study;
- •Patients with a history of chronic use of alcohol, smoke or other sedative drugs;
- •Patients took opioids and other analgesics before surgery;
- •Emergency operation;
- •Stress, anxiety resulting in secretion of catecholamine;
- •Patients with neuropsychiatric disorders, coma, depression, cognitive impairment and Alzheimer's disease;
- •Patients with epilepsy, autonomic nervous dysfunction and other diseases with abnormal EEG results;
- •SBP< 85 mmHg or HR< 45 次/min;
- •Has implanted pacemaker;
- •Patients were unwilling or disable to finish whole study;
- •Patients with acute upper respiratory infections, liver or kidney failure and severe cardiopulmonary dysfunction.
结局指标
主要结局
The rate of the IOC2 target a reachment
时间窗: through study completion, an average of 1 day
The primary endpoint of the study was the attainment rate of the IOC2 target during operation
次要结局
- visual analog scale score(12 hours and 24hours after surgery)
- The ratio of vomiting(0 day, 1 day, 2 day after operation)
- Systolic Blood Pressure(0 day)
- Dystolic Blood Pressure(0 day)
- Mean Blood Pressure(0 day)
- Heart rate(0 day)