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

NCT06534801 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2024(058)
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Oxycodone; Thoracoscopic Lobectomy; Acute Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I（Age < 65 years old)

EXPERIMENTAL

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

Group II(Age ≥65 years old)

EXPERIMENTAL

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

Interventions

Oxycodone will be administered intravenously in the group 1 DRUG

Oxycodone will be administered intravenously 30min before the end of surgery, and Dixon sequential method will be used for the study

Also known as: They are grouped according to age

Group II(Age ≥65 years old); Group I（Age < 65 years old)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jianbo Wu: lead

Related Publications (1)

• Zhang M, Liu Y, Cao J, Liu M, Gao X, Guo N, Wei C, Zhu Y, Sun Y, Wu J. The median effective dose of oxycodone for acute postoperative pain after thoracoscopic pulmonary surgery with intercostal nerve blockin in patients of different ages: a dose-finding study protocol. BMC Anesthesiol. 2025 Jul 1;25(1):323. doi: 10.1186/s12871-025-03198-5.

  PMID: 40597587 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Wu Jian bo, doctorate

CONTACT

18560083793; jianbowu@126.com

Zhang min, master

CONTACT

18364183909; ZM18364183909@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share