Metadona Oral em Cirurgia Cardíaca (OMICS)
The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
Minnesota
-
Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
• Undergoing elective cardiac surgery
Exclusion Criteria:
- Chronic pain requiring opioid medications as an outpatient
- Opioid use disorder on medication assistance treatment
- Prolonged QTc >500ms
- Chronic kidney disease with eGFR < 30mL/min
- Documented cirrhosis
- Intolerance to methadone
- Admitted inpatient in an intensive care unit (ICU) immediately prior to surgery
- Pregnancy at the time of surgery
- Subsequent surgeries after index surgery
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Intravenous methadone intraoperatively
Subjects in the IV methadone arm will receive methadone intravenously during cardiac surgery |
Patients will receive 0.3mg/kg methadone intravenously after induction of general anesthesia |
|
Experimental: Oral methadone, immediately prior to transport
Subjects in the oral methadone arm will receive methadone orally prior to cardiac surgery |
Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Amount of opioid medication used 72 hours post-extubation
Prazo: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
|
Opioid medication used at 72 hours post-extubation will be reported in morphine milligram equivalents |
From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Amount of opioid medication used 24 hours post-extubation
Prazo: From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
|
Opioid medication used at 24 hours post-extubation will be reported in morphine milligram equivalents |
From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
|
|
Amount of opioid medication used 48 hours post-extubation
Prazo: From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
|
Opioid medication used at 48 hours post-extubation will be reported in morphine milligram equivalents |
From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
|
|
Amount of opioid medication required throughout hospitalization
Prazo: From the time the patient is extubated until the time the patient leaves the hospital, approximately 10 days. Safety to leave the hospital is determined by the cardiac surgery team and can be several days after surgery or longer.
|
Opioid medication required from extubation until hospital discharge will be reported in morphine milligram equivalents |
From the time the patient is extubated until the time the patient leaves the hospital, approximately 10 days. Safety to leave the hospital is determined by the cardiac surgery team and can be several days after surgery or longer.
|
|
Amount of opioid medication required prior to extubation
Prazo: From arrival in the ICU until extubation, approximately 6 hours. Safety of extubation is determined by the intensive care unit team and usually occurs within several hours of ICU arrival, although this can be variable.
|
Opioid medication required between the end of surgery and extubation will be documented in morphine milligram equivalents. |
From arrival in the ICU until extubation, approximately 6 hours. Safety of extubation is determined by the intensive care unit team and usually occurs within several hours of ICU arrival, although this can be variable.
|
|
Pain scores after extubation
Prazo: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation
|
Pain will be assessed by nursing staff using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable. |
6 hours, 12 hours, 24 hours, 48 hours, and 72 hours after extubation
|
|
Time to extubation
Prazo: From the time the patient arrives in the ICU intubated until the time they are successfully extubated, approximately 12 hours. Safety of extubation is determined by the ICU team and usually occurs within several hours, although this can be variable.
|
This outcome will monitor the time in minutes from when a patient arrives in the ICU to the time the breathing tube is removed (extubation). |
From the time the patient arrives in the ICU intubated until the time they are successfully extubated, approximately 12 hours. Safety of extubation is determined by the ICU team and usually occurs within several hours, although this can be variable.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Krishnan Ramanujan, M.D., Mayo Clinic
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 25-007292
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