OxycodoneNCT06534801
Sequential Method Determination of Oxycodone for Thoracoscope Surgery Median Effective Dose of Acute Pain Treatment
A study testing Oxycodone will be administered intravenously in the group 1 in people with Oxycodone and Thoracoscopic Lobectomy, run by Jianbo Wu.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oxycodone, Thoracoscopic Lobectomy, Acute Postoperative Pain
- What is being tested?
- Oxycodone will be administered intravenously in the group 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Oxycodone will be administered intravenously in the group 1
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone will be administered intravenously in the group 1Drug
Also called They are grouped according to age
Oxycodone will be administered intravenously 30min before the end of surgery, and Dixon sequential method will be used for the study
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 . Receives: Drug: Oxycodone will be administered intravenously in the group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median effective dose
The median effective dose of oxycodone for the treatment of acute pain after thoracoscopic lobectomy
Measured: 3 minutes after remoal of the endotracheal tube, 30minutes after remoal of the endotracheal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OxycodoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianbo Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianbo Wu, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534801
- Sponsor's protocol ID
- YXLL-KY-2024(058)
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40597587
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Method Determination of Oxycodone for Thoracoscope Surgery Median Effective Dose of Acute Pain Treatment
- ClinicalTrials.gov ID
- NCT06534801
- Acronym / sponsor ID
- YXLL-KY-2024(058)
- Conditions
- Oxycodone, Thoracoscopic Lobectomy, Acute Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jianbo WuUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I（Age < 65 years old) | Experimental | Drug: Oxycodone will be administered intravenously in the group 1We 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) | Experimental | Drug: Oxycodone will be administered intravenously in the group 1We 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 . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone will be administered intravenously in the group 1Also: They are grouped according to ageOxycodone will be administered intravenously 30min before the end of surgery, and Dixon sequential method will be used for the study | Drug | Group II(Age ≥65 years old), Group I（Age < 65 years old) |
Primary outcome
The median effective dose
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Derived from this study: PubMed 40597587Zhang 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.
- Individual participant dataSharing planned: No
Related trials for Oxycodone
Active, not recruitingPhase 4
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone will be administered intravenously in the group 1 in people with Oxycodone and Thoracoscopic Lobectomy, run by Jianbo Wu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wu Jian bo, doctorate (18560083793, jianbowu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median effective dose (time frame: 3 minutes after remoal of the endotracheal tube, 30minutes after remoal of the endotracheal tube). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06534801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.