Sequential Method Determination of Oxycodone for Thoracoscope Surgery Median Effective Dose of Acute Pain Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- The median effective dose
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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 .
Intervention: 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 .
Intervention: Oxycodone will be administered intravenously in the group 1 (Drug)
Outcomes
Primary Outcomes
The median effective dose
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Jianbo Wu
Chief Physician
Qianfoshan Hospital