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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Kontakte und Standorte
Studienorte
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Pavia, Italien, 27100
- Fondazione IRCCS Policlinico San Matteo
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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).
Andere Namen:
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Group B
Both homozygous and heterozygous patients for the less 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).
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Varianten an den Loci OPRM1, COMT, UGTs, ESR1, in Richtung des mittleren Schmerzmaßes
Zeitfenster: während 24 Stunden nach der Operation
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Häufigkeit der Varianten an den Loci OPRM1, COMT, UGTs, ESR1, sowohl bei Patienten mit NRS ≤4 als auch bei Patienten mit NRS >4 mindestens einmal innerhalb von 24 Stunden.
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während 24 Stunden nach der Operation
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Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Massimo Allegri, MD, IRCCS Policlinico San Matteo
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PT-SM-08-MorfinaContinua-Gene
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