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

Not Applicable

Not yet recruiting

• Conditions: Acute Postoperative Pain; Oxycodone; Thoracoscopic Lobectomy
• Interventions: Drug: Oxycodone will be administered intravenously in the group 1

• Registration Number: NCT06534801
• Lead Sponsor: Jianbo Wu

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-02
• Last Update Posted: 2024-08-02
• Study Start: 2024-09-01
• Primary Completion: 2025-07-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I（Age < 65 years old)	Oxycodone will be administered intravenously in the group 1	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 .
Group II(Age ≥65 years old)	Oxycodone will be administered intravenously in the group 1	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 .

Primary Outcome Measures

Name	Time	Method
The median effective dose	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