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Not yet recruitingNCT06534801Updated Aug 2, 2024

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

An interventional study of Oxycodone will be administered intravenously in the group 1 in Oxycodone, Thoracoscopic Lobectomy and Acute Postoperative Pain, sponsored by Jianbo Wu. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Jianbo Wu · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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

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Conditions studied

  • Oxycodone
  • Thoracoscopic Lobectomy
  • Acute Postoperative Pain
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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Jianbo Wu is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugOxycodone 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

    Also known as: They are grouped according to age

06

What researchers measure

Primary outcomes

  1. The median effective dose

    The median effective dose of oxycodone for the treatment of acute pain after thoracoscopic lobectomy

    Time frame: 3 minutes after remoal of the endotracheal tube, 30minutes after remoal of the endotracheal tube

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06534801
Lead sponsor
Jianbo Wu
Responsible party
Jianbo Wu (Chief Physician, Qianfoshan Hospital) — Sponsor-investigator
First posted
Aug 2, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Jul 1, 2025 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Aug 2, 2024

Study contacts

Wu Jian bo, doctorate
Contact
jianbowu@126.com
18560083793
Zhang min, master
Contact
ZM18364183909@163.com
18364183909

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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