Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 4:00 AM
Study NCT ID:
NCT07484867
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of CYP2D6 on Perioperative Analgesia of Oxycodone in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D055613', 'term': 'Multiple Pulmonary Nodules'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS pain score during recovery period and after operation.', 'timeFrame': 'Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.', 'description': 'VAS pain score : 0 : painless ; 1-3 points : mild pain ; 4-6 points : moderate pain ; 7-10 points : severe pain.'}], 'secondaryOutcomes': [{'measure': 'Ricker sedation-agitation score during recovery period.', 'timeFrame': 'Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.', 'description': '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.'}, {'measure': 'MOAA / S sedation score during recovery period and after operation.', 'timeFrame': 'Wake up for 30 minutes and 1 day, 2 days, 3 days after operation.', 'description': "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 ."}, {'measure': 'Awakening time', 'timeFrame': 'The time from the end of surgery to extubation.'}, {'measure': 'Extubation time.', 'timeFrame': 'Patients with muscle strength, consciousness, breathing has been restored time.'}, {'measure': 'The amount of opioids was added during the recovery period.', 'timeFrame': 'The patient stayed in the recovery room.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Pulmonary Nodules', 'Oxycodone']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "During the trial period, patients who needed thoracoscopic lung surgery in Henan Provincial People 's Hospital were older than 60 years old.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n( 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 ' ).\n\n\\-\n\nExclusion Criteria:\n\n( 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.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT07484867', 'briefTitle': 'Effect of CYP2D6 on Perioperative Analgesia of Oxycodone in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': "Henan Provincial People's Hospital"}, 'officialTitle': 'Effect of CYP2D6 on Perioperative Analgesia of Oxycodone in Elderly Patients', 'orgStudyIdInfo': {'id': 'Henan-CPP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PM group', 'interventionNames': ['Drug: oxycodone']}, {'label': 'IM group', 'interventionNames': ['Drug: oxycodone']}, {'label': 'NM group', 'interventionNames': ['Drug: oxycodone']}, {'label': 'UM group', 'interventionNames': ['Drug: oxycodone']}], 'interventions': [{'name': 'oxycodone', 'type': 'DRUG', 'description': '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 ).', 'armGroupLabels': ['IM group', 'NM group', 'PM group', 'UM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}