Effect of CYP2D6 on Perioperative Analgesia of Oxycodone in Elderly Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- VAS pain score during recovery period and after operation.
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 ' ).
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.
Arms & Interventions
PM group
Intervention: oxycodone (Drug)
IM group
Intervention: oxycodone (Drug)
NM group
Intervention: oxycodone (Drug)
UM group
Intervention: oxycodone (Drug)
Outcomes
Primary Outcomes
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
- 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.)