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

NCT07484867 | Completed

• 1 other identifier: Henan-CPP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. The significance is to accurately guide the perioperative analgesia of oxycodone in elderly patients, and to more effectively avoid toxicity and adverse reactions.

Conditions

Pain; Pulmonary Nodules; Oxycodone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Ricker sedation-agitation score during recovery period.

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

• MOAA / S sedation score during recovery period and after operation.

  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.

Study Arms (4)

PM group

Drug: oxycodone

IM group

Drug: oxycodone

NM group

Drug: oxycodone

UM group

Drug: oxycodone

Interventions

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 ).

IM group; NM group; PM group; UM group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ( 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 ' ).

You may not qualify if:

• ( 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Pain; Multiple Pulmonary Nodules

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: March 20, 2026
• Study Start: January 1, 2025
• Primary Completion: June 15, 2025
• Study Completion: September 30, 2025
• Last Updated: May 12, 2026

Record last verified: 2026-03

Locations

CN (1)