Sequential Method Determination of Oxycodone for Thoracoscope Surgery Median Effective Dose of Acute Pain Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- The median effective dose
研究概览
简要总结
The goal of this clinical trial is to measure the median effective dose of oxycodone for the treatment of acute pain after thoracoscopic lobectomy. This clinical trial was divided into two groups based on age, Group I (Age < 65 years old) and Group II (Age ≥65 years old). We used the sequential allocation designed by Dixon. The initial oxycodone dose was set to 0.1 mg/kg.A satisfactory or an unsatisfactory analgesic response of the previous patient determined, respectively, the relative 10% decrease or increase in the dose of oxycodone the next patient received in the same group. The patient before the first crossover point was included as the first case for ED50 estimation in each group.The study was conducted until 7 crossover points were collected
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The first unilateral thoracoscopic lobectomy was performed under general anesthesia
- •age 18- 80 years old
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Sign the informed consent of the patients
排除标准
- •Moderate to severe obesity (i.e., BMI > 30kg/m2)
- •Allergic or hypersensitive reaction to oxycodon
- •A history of chronic pain
- •Patients with significant heart, pulmonary, liver or renal disease
研究组 & 干预措施
Group I（Age < 65 years old)
We will use the sequential allocation designed by Dixon. Oxycodone will be administered intravenously 30min before the end of surgery. The initial oxycodone dose will be set to 0.1 mg/kg. A satisfactory or an unsatisfactory analgesic response of the previous patient determined, respectively, the relative 10% decrease or increase in the dose of oxycodone the next patient received in the same group. The patient before the first crossover point will be included as the first case for ED50 estimation in each group. The study will conducted until 7 crossover points have be collected .
干预措施: Oxycodone will be administered intravenously in the group 1 (Drug)
Group II(Age ≥65 years old)
We will use the sequential allocation designed by Dixon. Oxycodone will be administered intravenously 30min before the end of surgery. The initial oxycodone dose will be set to 0.1 mg/kg. A satisfactory or an unsatisfactory analgesic response of the previous patient determined, respectively, the relative 10% decrease or increase in the dose of oxycodone the next patient received in the same group. The patient before the first crossover point will be included as the first case for ED50 estimation in each group. The study will conducted until 7 crossover points have be collected .
干预措施: Oxycodone will be administered intravenously in the group 1 (Drug)
结局指标
主要结局
The median effective dose
时间窗: 3 minutes after remoal of the endotracheal tube, 30minutes after remoal of the endotracheal tube
The median effective dose of oxycodone for the treatment of acute pain after thoracoscopic lobectomy
次要结局
未报告次要终点
研究者
Jianbo Wu
Chief Physician
Qianfoshan Hospital