Effect of CYP2D6*10 Gene Mutation on Perioperative Precision Analgesia of Oxycodone in Elderly Patients

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pulmonary Nodules; Oxycodone
• Intervention / Treatment: Drug: oxycodone

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

During the trial period, patients who needed thoracoscopic lung surgery in Henan Provincial People 's Hospital were older than 60 years old.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PM group	Drug: oxycodone; 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 ).
IM group	Drug: oxycodone; 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 ).
NM group	Drug: oxycodone; 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 ).
UM group	Drug: oxycodone; 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 ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 .	Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.
Awakening time		The time from the end of surgery to extubation.
Extubation time.		Patients with muscle strength, consciousness, breathing has been restored time.
The amount of opioids was added during the recovery period.		The patient stayed in the recovery room.

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Multiple Pulmonary Nodules; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Oxycodone
• Other Study ID Numbers: Henan-CPP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No