Association Between Clinical Effect of Morphine With PCA After Surgery and Pharmacogenetics
Information source: IRCCS Policlinico S. Matteo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia; Surgery
Intervention: morphine chlorhydrate (Drug)
Phase: N/A
Status: Completed
Sponsored by: IRCCS Policlinico S. Matteo Official(s) and/or principal investigator(s): Massimo Allegri, MD, Principal Investigator, Affiliation: IRCCS Policlinico San Matteo
Summary
Identification of the genetic polymorphisms that could be correlated either with a better
clinical response or with a major predisposition of patients to develop tolerance and/or
side effects to the treatment with morphine.
Clinical Details
Official title: Association Between Clinical Effect of Morphine in Patients With PCA After Major Surgery and Pharmacogenetics: Prospective Observational Clinical Study.
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Assessment of the medium morphine dose (mg/kg/die)in the two groups homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene; group B: both homozygous and heterozygous patients for the less frequent allele
Secondary outcome: Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measureDetection of the medium morphine dose Pharmacokinetics of morphine with PCA after surgery Variants frequency at loci OPRM1, COMT, UGTs, ESR1 Detection of the possible side effects. Detection of the association between M3G/M6G ratio and polymorphisms of UGTs (and possible side effects).
Detailed description:
Valuation of the medium morphine dose (mg/kg/die) necessary to maintain NRS<4 in the first
24 hours post-surgery in the two groups of patients, A e B. Group A: homozygous patients for
the more frequent allele of the polymorphism A118G of OPRM1 gene (about 80%); group B: both
homozygous and heterozygous patients for the less frequent allele (about 20%).
In order to avoid the bias related to alterations in metabolism, patients with Cmax and AUC
of morphine (and metabolites M6G and M3G) >2 standard deviation higher than expected
population curve ("outliers") will be excluded for the primary purpose.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Males and females over 18 years, under 75 years, scheduled for postoperative pain
control by PCA morphine administration
- HIV negative
- Classification American Society of Anesthesiologists (ASA) I: without systemic
disease
- Classification ASA II or III (mild systemic disease or severe systemic disease that
limits the activity without invalidity).
- Undergoing abdominal and urologic major surgery (neither urgent nor emergency
surgery)
- Signed informed consent
Exclusion criteria:
- Usual assumption of analgesic opioids
- Cognitive alterations nor mental retardation
- Severe hepatic/renal insufficiency (cholinesterase <3000 mU/ml, total bilirubinaemia
<2 mg/dl and creatininaemia <1. 2 mg/dl)
- Inpatients in intensive therapy, either with sedation and/or mechanic ventilation.
- Allergies to morphine and derivates
Locations and Contacts
Azienda Ospedaliera San Gerardo, Monza 20052, Italy
Fondazione IRCCS Policlinico San Matteo, Pavia 27100, Italy
Additional Information
Starting date: July 2010
Last updated: July 18, 2013
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