Association Between Clinical Effect of Continuous Morphine Administration After Surgery and Pharmacogenetics
Association Between Clinical Effect of Continuous Morphine Administration in Patients After Major Surgery and Pharmacogenetics: Perspective Observational Clinical Study
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Kontakter og plasseringer
Studiesteder
-
-
-
Pavia, Italia, 27100
- Fondazione IRCCS Policlinico San Matteo
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion criteria:
- Males and females over 18 years, under 75 years, scheduled for postoperative pain control with continuous 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Group A
Homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene
|
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 continuous infusion for 48h with morphine chlorhydrate 0,02 mg/kg/h. Moreover, a rescue dose therapy will be prescribed with ketoprofen 160 mg or ketorolac 30mg (in case of allergy acetaminophene 1g) if NRS<4 maximum x 3 daily. Postoperative analgesic treatment is lasting 48h for each patient (between starting of the infusion (T0) and the following 48h).
Andre navn:
|
|
Group B
Both homozygous and heterozygous patients for the less frequent allele of the polymorphism A118G of OPRM1 gene
|
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 continuous infusion for 48h with morphine chlorhydrate 0,02 mg/kg/h. Moreover, a rescue dose therapy will be prescribed with ketoprofen 160 mg or ketorolac 30mg (in case of allergy acetaminophene 1g) if NRS<4 maximum x 3 daily. Postoperative analgesic treatment is lasting 48h for each patient (between starting of the infusion (T0) and the following 48h).
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of the rescue doses 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
Tidsramme: first 24 h after surgery
|
Valuation of the rescue doses 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%).
|
first 24 h after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Varianter på loki OPRM1, COMT, UGT, ESR1, mot median smertemål
Tidsramme: i løpet av 24 timer etter operasjonen
|
Frekvens av variantene ved loki OPRM1, COMT, UGTs, ESR1, både hos pasienter med NRS ≤4 og hos de som har NRS >4 minst én gang i løpet av 24 timer.
|
i løpet av 24 timer etter operasjonen
|
|
Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure
Tidsramme: period between 24 - 48 h postsurgery
|
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 the period between 24-48 hours postsurgery.
|
period between 24 - 48 h postsurgery
|
|
Pharmacokinetics of morphine during continuous administration after surgery
Tidsramme: 48 h after surgery
|
Pharmacokinetic study of both morphine and its principal active and/or toxic metabolites (M3G and M6G).
|
48 h after surgery
|
|
Detection of the possible side effects.
Tidsramme: 72 h postopratively
|
Detection of the possible side effects after continuous morphine administration
|
72 h postopratively
|
|
Detection of the association between M3G/M6G ratio and polymorphisms of UGTs
Tidsramme: within 72 h postoperatively
|
Detection of the association between M3G/M6G ratio and polymorphisms of UGTs and its possible side effects.
|
within 72 h postoperatively
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Massimo Allegri, MD, IRCCS Policlinico San Matteo
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PT-SM-08-MorfinaContinua-Gene
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .