Sequential Method Determination of Oxycodone for Thoracoscope Surgery Median Effective Dose of Acute Pain Treatment

Jianbo Wu

Status: Not yet enrolling

Conditions: Oxycodone; Acute Postoperative Pain; Thoracoscopic Lobectomy

Treatments: Drug: Oxycodone will be administered intravenously in the group 1

Study type: Interventional

Funder types: Other

Identifiers

NCT06534801

YXLL-KY-2024(058)

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The first unilateral thoracoscopic lobectomy was performed under general anesthesia
2. age 18- 80 years old
3. American Society of Anesthesiologists (ASA) physical status I-III
4. Sign the informed consent of the patients

Exclusion criteria

1. Moderate to severe obesity (i.e., BMI > 30kg/m2)
2. Allergic or hypersensitive reaction to oxycodon
3. A history of chronic pain
4. Patients with significant heart, pulmonary, liver or renal disease

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Group I（Age < 65 years old)

Experimental group

Description:

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 .

Treatment:

Drug: Oxycodone will be administered intravenously in the group 1

Group II(Age ≥65 years old)

Experimental group

Description:

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 .

Treatment:

Drug: Oxycodone will be administered intravenously in the group 1