PainNCT07484867
Effect of CYP2D6*10 Gene Mutation on Perioperative Precision Analgesia of Oxycodone in Elderly Patients
An observational study of Pain and Pulmonary Nodules, run by Henan Provincial People's Hospital at 1 site in China.
Trial summary
The purpose of this prospective study was to determine the effect of CYP2D6 gene polymorphism on perioperative analgesia of oxycodone in elderly patients, and to assign the CYP2D6 phenotype according to the genotype, and to use inhibitors for pain control of phenotype conversion. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Pulmonary Nodules, Oxycodone
- What is being tested?
- oxycodone
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Observational
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: During the trial period, patients who needed thoracoscopic lung surgery in Henan Provincial People 's Hospital were older than 60 years old.
Who may be able to join
- ( 1 ) Age ≥ 60 years old ; ( 2 ) ASA grade I ~ II ; ( 3 ) Receiving radical resection of lung cancer ; ( 4 ) BMI was 18.5 ~ 29.9 kg / m2 [ BMI = weight ( Kg ) / height ( m ) 2 ] ( 2013 US ' Adult Overweight and Obesity Management Guidelines ' ).
- -
Who cannot join
- ( 1 ) Patients with severe liver and kidney dysfunction ( severe liver dysfunction : ALT, AST, ALP, total bilirubin, etc. One of them > 2 times the upper limit of normal value. Severe renal dysfunction : creatinine > 2 times the upper limit of normal ) ; ( 2 ) Identify / suspect abuse or long-term use of narcotic sedative analgesics ; ( 3 ) Reoperation within 3 months ; ( 4 ) Patients with contraindications or allergies to test drugs and other narcotic drugs ; ( 5 ) CYP2D6 inhibitors or inducers were used within 30 days ; ( 6 ) Have a history of smoking, heavy drinking or drug use.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of CYP2D6 on Perioperative Analgesia of Oxycodone in Elderly Patients
The purpose of this prospective study was to determine the effect of CYP2D6 gene polymorphism on perioperative analgesia of oxycodone in elderly patients, and to assign the CYP2D6 phenotype according to the genotype, and to use inhibitors for pain control of phenotype conversion. The significance is to accurately guide the perioperative analgesia of oxycodone in elderly patients, and to more effectively avoid toxicity and adverse reactions.
Read the detailed description
CYP2D6 is a subfamily of P450, and its gene is highly polymorphic, which can affect the conversion of enzyme activity. CYP2D6 is involved in the metabolism of opioid drugs such as morphine, tramadol, codeine, oxycodone and so on. According to allele mutation, CYP2D6 individuals are predicted to have different phenotypes : weak metabolizer ( PM ), intermediate metabolizer ( IM ), normal metabolizer ( NM ) and ultra-fast metabolizer ( UM ).The data from this study support the potential benefits of CYP2D6-guided pain treatment, using inhibitors to reduce CYP2D6 metabolic activity, reduce the production of excessive metabolites, and avoid toxicity and adverse reactions. Oxycodone is a μ-opioid receptor agonist. A number of studies have found that significant genetic variations in CYP2D6 activity affect the conversion of oxycodone. Gene polymorphism significantly affects the metabolism and elimination of oxycodone by affecting the enzyme activity of CYP2D6, thus affecting its analgesic effect.
- Conditions
- Pain, Pulmonary Nodules, Oxycodone
- Being tested
- oxycodone
- Medical subject headings
- Pain, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxycodoneDrug
All patients undergoing thoracic surgery were given oxycodone 0.07 mg / kg for bridging analgesia 20 minutes before the end of surgery. Patient-controlled intravenous analgesia pump was connected within 5 minutes after operation ( formula : oxycodone 0.5 mg / kg + dexmedetomidine 3 μg / kg + tropisetron 0.3 mg / kg = 150 ml ).
| Study group | Role | What they receive |
|---|---|---|
| PM group | Not described Receives: Drug: oxycodone | |
| IM group | Not described Receives: Drug: oxycodone | |
| NM group | Not described Receives: Drug: oxycodone | |
| UM group | Not described Receives: Drug: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain score during recovery period and after operation.
VAS pain score : 0 : painless ; 1-3 points : mild pain ; 4-6 points : moderate pain ; 7-10 points : severe pain.
Measured: Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.
Secondary outcomes (5)
Ricker sedation-agitation score during recovery period.
Ricker sedation-agitation score : The higher the score, the more restless the patient is, the lower the score, the more calm and sleep the patient is.
Measured: Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.
MOAA / S sedation score during recovery period and after operation.
MOAA / S score : the higher the score ( 5 points ), the more awake the patient ; the lower the score ( 0 ), the deeper the patient 's sedation .
Measured: Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.
Awakening time
Measured: The time from the end of surgery to extubation.
Extubation time.
Measured: Patients with muscle strength, consciousness, breathing has been restored time.
The amount of opioids was added during the recovery period.
Measured: The patient stayed in the recovery room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Jan 2025
- Primary completion15 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484867
- Sponsor's protocol ID
- Henan-CPP
- Status last verified
- Mar 2026
- First submitted
- 4 Jun 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CYP2D6 on Perioperative Analgesia of Oxycodone in Elderly Patients
- ClinicalTrials.gov ID
- NCT07484867
- Acronym / sponsor ID
- Henan-CPP
- Conditions
- Pain, Pulmonary Nodules, Oxycodone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 20 Mar 2026 (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 purpose of this prospective study was to determine the effect of CYP2D6 gene polymorphism on perioperative analgesia of oxycodone in elderly patients, and to assign the CYP2D6 phenotype according to the genotype, and to use inhibitors for pain control of phenotype conversion. The significance is to accurately guide the perioperative analgesia of oxycodone in elderly patients, and to more effectively avoid toxicity and adverse reactions.
Detailed description
CYP2D6 is a subfamily of P450, and its gene is highly polymorphic, which can affect the conversion of enzyme activity. CYP2D6 is involved in the metabolism of opioid drugs such as morphine, tramadol, codeine, oxycodone and so on. According to allele mutation, CYP2D6 individuals are predicted to have different phenotypes : weak metabolizer ( PM ), intermediate metabolizer ( IM ), normal metabolizer ( NM ) and ultra-fast metabolizer ( UM ).The data from this study support the potential benefits of CYP2D6-guided pain treatment, using inhibitors to reduce CYP2D6 metabolic activity, reduce the production of excessive metabolites, and avoid toxicity and adverse reactions. Oxycodone is a μ-opioid receptor agonist. A number of studies have found that significant genetic variations in CYP2D6 activity affect the conversion of oxycodone. Gene polymorphism significantly affects the metabolism and elimination of oxycodone by affecting the enzyme activity of CYP2D6, thus affecting its analgesic effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PM group | – | Drug: oxycodone |
| IM group | – | Drug: oxycodone |
| NM group | – | Drug: oxycodone |
| UM group | – | Drug: oxycodone |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- During the trial period, patients who needed thoracoscopic lung surgery in Henan Provincial People 's Hospital were older than 60 years old.
Key inclusion criteria (2 listed)
- ( 1 ) Age ≥ 60 years old ; ( 2 ) ASA grade I ~ II ; ( 3 ) Receiving radical resection of lung cancer ; ( 4 ) BMI was 18.5 ~ 29.9 kg / m2 [ BMI = weight ( Kg ) / height ( m ) 2 ] ( 2013 US ' Adult Overweight and Obesity Management Guidelines ' ).
- -
Key exclusion criteria (2 listed)
- ( 1 ) Patients with severe liver and kidney dysfunction ( severe liver dysfunction : ALT, AST, ALP, total bilirubin, etc. One of them > 2 times the upper limit of normal value. Severe renal dysfunction : creatinine > 2 times the upper limit of normal ) ; ( 2 ) Identify / suspect abuse or long-term use of narcotic sedative analgesics ; ( 3 ) Reoperation within 3 months ; ( 4 ) Patients with contraindications or allergies to test drugs and other narcotic drugs ; ( 5 ) CYP2D6 inhibitors or inducers were used within 30 days ; ( 6 ) Have a history of smoking, heavy drinking or drug use.
- -
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 |
|---|---|---|
| oxycodoneAll patients undergoing thoracic surgery were given oxycodone 0.07 mg / kg for bridging analgesia 20 minutes before the end of surgery. Patient-controlled intravenous analgesia pump was connected within 5 minutes after operation ( formula : oxycodone 0.5 mg / kg + dexmedetomidine 3 μg / kg + tropisetron 0.3 mg / kg = 150 ml ). | Drug | IM group, NM group, PM group, UM group |
Primary outcome
VAS pain score during recovery period and after operation.
Time frame: Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.
VAS pain score : 0 : painless ; 1-3 points : mild pain ; 4-6 points : moderate pain ; 7-10 points : severe pain.
5 secondary outcomes
Ricker sedation-agitation score during recovery period.
Time frame: Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.
MOAA / S sedation score during recovery period and after operation.
Time frame: Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.
Awakening time
Time frame: The time from the end of surgery to extubation.
Extubation time.
Time frame: Patients with muscle strength, consciousness, breathing has been restored time.
The amount of opioids was added during the recovery period.
Time frame: The patient stayed in the recovery room.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Pulmonary Nodules, run by Henan Provincial People's Hospital at 1 site in China.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain score during recovery period and after operation. (time frame: Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.