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- Ensaio Clínico NCT00405977
The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block (MagRoc)
The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block - A Randomised Electrophysiology Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
In a previous study pre-treatment with intravenous MgSO4 60 mg kg-1 was not shown to have any impact on the onset of action of rocuronium [Kussmann et al, 1997]. Yet, in that study, MgSO4 was injected as a bolus after induction of anaesthesia, one minute only before the injection of the neuromuscular blocking agent. We suppose that magnesium needs some time to penetrate the neuromuscular endplate and to shift the Mg/Ca ratio in favor of magnesium. Thus, the particular design of the previous study may explain why magnesium had no scope to enhance the speed of onset of action of rocuronium.
The aim of our study is to investigate whether an optimised pre-treatment with magnesium (short infusion rather than bolus injection; reasonable delay between administration of magnesium and subsequent injection of the neuromuscular blocking agent) enhances the speed of onset of a standard intubation dose of rocuronium.
Preanaesthetic preparation
- Solid food and liquid intake will not be allowed for a minimum of six hours before induction
- Patients will be premedicated with 7.5 mg oral midazolam 45 min prior to induction
- Standard monitoring will consist of: ECG, SaO2, ETCO2, non-invasive blood pressure, rectal or oesophageal T°
Study drug administration
- Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group. The infusion will be given with an Infusomat during 15 minutes.
Induction and maintenance of anaesthesia
- At the end of the study drug infusion, and after a preoxygenation period of three minutes, anaesthesia will be induced with sufentanil 0.2µg kg-1 and propofol, using a Target Controlled Infusion (TCI) system (Base Primea, Fresenius-Vial, Brezins, France) and the pharmacokinetic model of Schnider et al [Schnider et al, 1999]. The initial effect site concentration will be 4 µg ml-1.
- Maintenance of anaesthesia will be with a propofol effect site
Neuromuscular monitoring
- Neuromuscular function will be monitored using the TOF Watch® SX (NV Organon) and TOF nerve stimulation. The guidelines for good clinical research practice in pharmacodynamic studies of NMBAs will be followed.
- The ulnar nerve is stimulated through surface electrodes, and the adductor pollicis muscle response is measured.
- After the stabilisation period, rocuronium 0.6 mg kg-1 (2 x ED95) will be injected intravenously during 5 seconds.
- The trachea will be intubated after a 95% depression of the first twitch
5.1. Neuromuscular measurements
- Onset time = time from beginning of injection of rocuronium until a 95% depression of the first twitch (T1).
- Duration 25% = time from beginning of injection of rocuronium until 25% T1 recovery.
- Recovery index T25-75 = time between 25% T1 recovery and 75% T1 recovery.
- Clinical recovery T25 - 0.9 = time between 25% T1 recovery and TOF ratio (T1/T4) of 0.9 (corresponding to safe extubation condition).
5.2. Haemodynamics
- Blood pressure
- Heart rate These measurements will be done before (baseline), and at 5-minute intervals during the study drug infusion. Before and immediately after tracheal intubation, haemodynamic measurements will be repeated.
5.3. Adverse events, safety
- Any minor adverse event (no need for intervention) or major adverse events will be recorded.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Canton of Geneva
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Geneva, Canton of Geneva, Suíça, 1211
- University Hospital of Geneva, Anesthesia Department
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- American Society of Anaesthesiology (ASA) status I or II
- Adults, aged 18 years to 60 years
- Scheduled for elective surgery lasting longer than 120 min without need for continuous curarisation
Exclusion Criteria:
- A history of allergy or hypersensitivity to rocuronium
- Neuromuscular disease
- Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics and anticonvulsants)
- Electrolyte abnormalities
- Hepatic or renal insufficiency
- Patients with a body mass index <19 or >28 kg m2
- Pregnant or breastfeeding women
- Expected difficult intubation or mask ventilation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Soro fisiológico
|
Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group and 1 ml per kg physiological saline.
The infusion will be given with during 15 minutes.
|
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Comparador Ativo: Magnesium sulphate
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Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group.
The infusion will be given during 15 minutes.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To study whether a pre-treatment with MgSO4, 60 mg kg-1, administered as an intravenous infusion 15 minutes prior to induction enhances the speed of onset of a standard intubation dose of rocuronium
Prazo: 1 to 5 minutes
|
Onset time ist the time in seconds from start of injection of rocuronium until 95% depression of the first twitch (T1) of the Train of four (TOF)
|
1 to 5 minutes
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
To study whether, and to what extent, pre-treatment with MgSO4 prolongs recovery characteristics of the neuromuscular block that is induced by rocuronium
Prazo: minutes to hours
|
minutes to hours
|
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To study possible haemodynamic effects of pre-treatment with MgSO4.
Prazo: hours
|
hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christoph A Czarnetzki, MD, MBA, University Hospital of Geneva, Anesthesia Department
- Cadeira de estudo: Martin Tramer, MD, PhD, University Hospital of Geneva, Anesthesia Department
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antiarrítmicos
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Anestésicos
- Moduladores de transporte de membrana
- Anticonvulsivantes
- Hormônios e Agentes Reguladores de Cálcio
- Agentes de Controle Reprodutivo
- Bloqueadores dos Canais de Cálcio
- Tocolíticos
- Sulfato de magnésio
Outros números de identificação do estudo
- CER 05-055
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