- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01233219
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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Pavia, Italien, 27100
- Fondazione IRCCS Policlinico San Matteo
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Group A
Homozygous patients for the more frequent allele of the polymorphism A118G of OPRM1 gene
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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 navne:
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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 navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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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%).
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first 24 h after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Varianter ved loci OPRM1, COMT, UGT'er, ESR1, mod median smertemåling
Tidsramme: i løbet af 24 timer efter operationen
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Frekvensen af varianterne ved loci OPRM1, COMT, UGT'er, ESR1, både hos patienter med NRS ≤4 og hos dem, der har NRS >4 mindst én gang i løbet af 24 timer.
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i løbet af 24 timer efter operationen
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Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure
Tidsramme: period between 24 - 48 h postsurgery
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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.
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period between 24 - 48 h postsurgery
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Pharmacokinetics of morphine during continuous administration after surgery
Tidsramme: 48 h after surgery
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Pharmacokinetic study of both morphine and its principal active and/or toxic metabolites (M3G and M6G).
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48 h after surgery
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Detection of the possible side effects.
Tidsramme: 72 h postopratively
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Detection of the possible side effects after continuous morphine administration
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72 h postopratively
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Detection of the association between M3G/M6G ratio and polymorphisms of UGTs
Tidsramme: within 72 h postoperatively
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Detection of the association between M3G/M6G ratio and polymorphisms of UGTs and its possible side effects.
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within 72 h postoperatively
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Massimo Allegri, MD, IRCCS Policlinico San Matteo
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PT-SM-08-MorfinaContinua-Gene
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