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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Contactos e Locais
Locais de estudo
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Pavia, Itália, 27100
- Fondazione IRCCS Policlinico San Matteo
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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).
Outros nomes:
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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).
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Variantes nos loci OPRM1, COMT, UGTs, ESR1, em relação à medida mediana da dor
Prazo: durante 24 h pós-cirurgia
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Frequência das variantes nos loci OPRM1, COMT, UGTs, ESR1, tanto em pacientes com NRS ≤4 como naqueles com NRS >4 pelo menos uma vez durante 24 horas.
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durante 24 h pós-cirurgia
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Variants at the loci OPRM1, COMT, UGTs, ESR1,towards median pain measure
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Massimo Allegri, MD, IRCCS Policlinico San Matteo
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PT-SM-08-MorfinaContinua-Gene
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