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Report for Clinical Trial NCT01233752

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Association Between Clinical Effect of Morphine in Patients With PCA After Major Surgery and Pharmacogenetics: Prospective Observational Clinical Study.

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.

NCT01233752 Anesthesia Surgery

1 Interventions

Name: morphine chlorhydrate

Description: The drug will be administrated by a bolus 45 minutes before the end of the surgery, with the following modalities: bolus with morphine chlorhydrate 0.15 mg/kg ± 20%. Also acetaminophene 1g and ketoprofen 160 mg (ketorolac 30mg) will be administrated during the operation. At the exit of the operative compartment patients will have an electronic pump (PCA) for 48h with morphine chlorhydrate to be used in boluses by 1 mg with a lock out of 5 mins, max dose 20 mg in 4 hours. Moreover, ketoprofen will be prescribed 160 mg x 2 per day (ketorolac 30mg x 2) (in case of allergy acetaminophene 1g x 3 daily). Postoperative analgesic treatment is lasting 48h for each patient (between starting of the PCA infusion (T0) and the following 48h).
Type: Drug
Group Labels: 2

Group A Group B


Primary Outcomes

Description: Valutation 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%).

Measure: 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

Time: first 24 h after surgery

Secondary Outcomes

Description: Frequency of the variants at the loci OPRM1, COMT, UGTs, ESR1, both in patients with NRS ≤4 and in those having NRS >4 at least once during 24 hours.

Measure: Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure

Time: during 24 h postsurgery

Description: Detection of the medium morphine dose (mg/kg/die) necessary to maintain NRS<4 though the first 48 hours after surgery.

Measure: Detection of the medium morphine dose

Time: First 24 h after surgery

Description: Pharmacokinetic study of both morphine and its principal active and/or toxic metabolites (M3G and M6G).

Measure: Pharmacokinetics of morphine with PCA after surgery

Time: 48 h after surgery

Description: Variants frequency at loci OPRM1, COMT, UGTs, ESR1 in the patients with Cmax and AUC of both morphine and M3G-M6G metabolites >2 standard deviations higher than expected population curve ("outliers").

Measure: Variants frequency at loci OPRM1, COMT, UGTs, ESR1

Time: Within 48h after surgery

Measure: Detection of the possible side effects.

Time: 72 h postopratively

Measure: Detection of the association between M3G/M6G ratio and polymorphisms of UGTs (and possible side effects).

Time: within 72 h postoperatively

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 A118G

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. --- A118G ---

Valutation 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%).. Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure. --- A118G ---

- Allergies to morphine and derivates Anesthesia Surgery 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%). --- A118G ---



HPO Nodes