Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery
Concordance Between Acceleromyography and Electromyography for Assessment of Neuromuscular Recovery at the End of Surgery
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Quantitative neuromuscular monitoring is recommended to reduce the incidence of residual neuromuscular blockade and its associated postoperative complications. Although electromyography is considered the current clinical reference method for objective neuromuscular monitoring, acceleromyography remains the most commonly used technique in routine clinical practice because of its availability, lower cost, and ease of use. However, acceleromyography may overestimate neuromuscular recovery, particularly when baseline normalization is not performed.
This prospective observational diagnostic agreement study will enroll adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia requiring administration of non-depolarizing neuromuscular blocking agents. At the end of surgery, before administration of neuromuscular blockade reversal agents, simultaneous train-of-four (TOF) ratio measurements will be obtained using acceleromyography and electromyography. Acceleromyography will be performed according to routine clinical practice without baseline normalization, while electromyography will serve as the reference method.
The primary objective is to evaluate the agreement between acceleromyography and electromyography measurements obtained at the end of surgery. Secondary objectives include estimating the mean bias between methods, calculating the 95% limits of agreement using Bland-Altman analysis, evaluating proportional bias, and determining the proportion of patients in whom acceleromyography indicates adequate neuromuscular recovery (TOF ≥0.9) while electromyography demonstrates residual neuromuscular blockade (TOF <0.9).
Demographic, clinical, and anesthetic variables will also be collected. Approximately 70 participants are expected to be enrolled.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 8431657
- Clínica Dávila
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Contato:
- Alejandra Rivera, MsC Epidemiology
- Número de telefone: 930363776
- E-mail: alejandra.rivera@davila.cl
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Adults aged 18 years or older.
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
- Administration of non-depolarizing neuromuscular blocking agents.
- Written informed consent provided.
Exclusion Criteria:
- Pre-existing neuromuscular disease.
- Upper extremity abnormalities preventing neuromuscular monitoring.
- Contraindications to neuromuscular monitoring.
- Refusal or inability to provide informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Adults Undergoing Elective Laparoscopic Cholecystectomy
Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade.
Simultaneous train-of-four (TOF) ratio measurements will be obtained at the end of surgery using acceleromyography and electromyography before administration of neuromuscular blockade reversal agents.
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Simultaneous quantitative neuromuscular monitoring using acceleromyography and electromyography to measure the train-of-four (TOF) ratio at the end of surgery before administration of neuromuscular blockade reversal agents.
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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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Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios
Prazo: At the end of surgery, before administration of neuromuscular blockade reversal agents
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Agreement between the train-of-four (TOF) ratios measured simultaneously by acceleromyography and electromyography at the end of surgery.
Agreement between the two measurement methods will be evaluated using Bland-Altman analysis.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Mean Bias Between Acceleromyography and Electromyography TOF Ratios
Prazo: At the end of surgery, before administration of neuromuscular blockade reversal agents
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Mean difference between the TOF ratio measured by acceleromyography and the TOF ratio measured by electromyography.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods
Prazo: At the end of surgery, before administration of neuromuscular blockade reversal agents
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Upper and lower 95% limits of agreement for the difference between acceleromyography and electromyography TOF ratio measurements, calculated using Bland-Altman analysis.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Proportional Bias Between Acceleromyography and Electromyography TOF Ratios
Prazo: At the end of surgery, before administration of neuromuscular blockade reversal agents
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Presence and magnitude of proportional bias between the two monitoring methods, evaluated by assessing the relationship between the difference in TOF ratios and the mean TOF ratio obtained by acceleromyography and electromyography.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography
Prazo: At the end of surgery, before administration of neuromuscular blockade reversal agents
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Proportion of participants in whom acceleromyography indicates adequate neuromuscular recovery, defined as a TOF ratio greater than or equal to 0.90, while electromyography indicates residual neuromuscular blockade, defined as a TOF ratio below 0.90.
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At the end of surgery, before administration of neuromuscular blockade reversal agents
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dagoberto Ojeda, MD, Clínica Dávila
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Palavras-chave
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Outros números de identificação do estudo
- CD2026/16
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