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

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 Overview

• Status: Not yet recruiting
• Conditions: Acute Postoperative Pain; Oxycodone; Thoracoscopic Lobectomy
• Intervention / Treatment: Drug: Oxycodone will be administered intravenously in the group 1

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wu Jian bo, doctorate; Phone Number: 18560083793; Email: jianbowu@126.com
• Study Contact Backup: Name: Zhang min, master; Phone Number: 18364183909; Email: ZM18364183909@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 .	Drug: Oxycodone will be administered intravenously in the group 1; Oxycodone will be administered intravenously 30min before the end of surgery, and Dixon sequential method will be used for the study; Other Names: They are grouped according to age
Experimental: 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 .	Drug: Oxycodone will be administered intravenously in the group 1; Oxycodone will be administered intravenously 30min before the end of surgery, and Dixon sequential method will be used for the study; Other Names: They are grouped according to age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The median effective dose	The median effective dose of oxycodone for the treatment of acute pain after thoracoscopic lobectomy	3 minutes after remoal of the endotracheal tube, 30minutes after remoal of the endotracheal tube

Collaborators and Investigators

• Sponsor: Jianbo Wu

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: YXLL-KY-2024(058)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No