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NCT Number: NCT07484867

Effect of CYP2D6*10 Gene Mutation on Perioperative Precision 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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

( 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 ' ).

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Exclusion criteria

( 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.

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Treatment and study plan

Oxycodone

Drug

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 ).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Ricker sedation-agitation score during recovery period.

    Time frame: Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.

    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.

  2. 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.

    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 .

  3. Awakening time

    Time frame: The time from the end of surgery to extubation.

  4. Extubation time.

    Time frame: Patients with muscle strength, consciousness, breathing has been restored time.

  5. The amount of opioids was added during the recovery period.

    Time frame: The patient stayed in the recovery room.

Sponsors and collaborators

Lead sponsor

Henan Provincial People's Hospital

Other

Registry information

Official study title

Effect of CYP2D6 on Perioperative Analgesia of Oxycodone in Elderly Patients

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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