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- Ensaio Clínico NCT02845375
Effect of Neuromuscular Blockade and Reversal on Breathing (BREATH)
Effect of Neuromuscular Blockade and Reversal by Sugammadex Versus Neostigmine on Breathing When Hypoxic or Hypercapnic in Volunteers
In this study the investigators will assess (i) the effect of partial neuromuscular blockade (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers.
Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The carotid bodies, located at the bifurcation of the common carotid artery, play a crucial and life-saving role in the control of breathing in humans. The carotid bodies contain type 1 cells that are primarily sensitive to low oxygen concentrations in arterial blood. In response to low oxygen the carotid bodies send information to the brainstem respiratory centers and a brisk hyperventilatory response will be initiated ensuring an increase in uptake of oxygen via the lungs. Following surgery, a rapid return of the carotid body function is vital and persistent loss of carotid body function may result in respiratory complications that occur independent of the effects of anesthetics (incl. muscle relaxants) on respiratory muscles. Respiratory complications that are related to the loss of carotid body function include the inability to respond properly to hypoxia as well the inability to overcome upper airway obstruction. The latter is especially important in patients with sleep disordered-breathing and obese patients. These patients rely on the optimal function of their carotid bodies in response to hypoxia or upper airway closure.
Important neurotransmitters involved in the carotid body response to hypoxia include acetylcholine, which acts through local nicotinergic acetylcholine receptors. Apart from the observation that muscle relaxants (which are blockers of the acetylcholine receptors) affect the proper functioning of the carotid bodies, the investigators have no knowledge on the dynamic effects of muscle relaxants on carotid body function over time or on the relationship between carotid body function and Train-of-Four (TOF) ratio over time. Additionally, there is no data on the link between the use of NMB antagonists and return of carotid body function. Linking TOF ratio to carotid body function is of clinical importance as a possible relationship will allow clinicians to predict carotid body function from the TOF ratio. The latter is highly relevant as the investigators show in a previous trial that a large proportion of patients is extubated at TOF ratio's < 0.7.
Apart from the carotid bodies, chemoreceptors in the brainstem exist that are sensitive to hypercapnia. This response system is not under control of cholinergic neurotransmission. Since the investigators may assume that the hypercapnic ventilatory response is not influenced by muscle relaxants the investigators can use this response to calibrate the hypoxic ventilatory response as both responses are equally affected by the effect of muscle relaxants on muscle function.
As stated there is data on the effect of muscle relaxants on carotid body function at one fixed TOF ratio (TOF ratio fixed at 0.7). No data are available on:
- Dynamic effect of carotid body function as measured by the hypoxic ventilatory response at TOF ratio's slowly changing from 0.6 to 1.0;
- Dynamic effect of reversal of NMB by sugammadex versus neostigmine. Sugammadex and neostigmine are both reversal agents of neuromuscular blockade. At their institution the investigators use both agents in clinical practice but remain without knowledge on their effects on carotid body function. The current proposal is designed to study items 1 and 2 in healthy awake volunteers.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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ZH
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Leiden, ZH, Holanda, 2333 ZA
- Leiden University Medical Center
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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:
- male gender
- age 18 years and older
- body mass index < 30 kg/m2.
Exclusion Criteria:
- Known or suspected neuromuscular disorders impairing neuromuscular function;
- allergies to muscle relaxants, anesthetics or narcotics;
- a (family) history of malignant hyperthermia or any other muscle disease;
- any medical, neurological or psychiatric illness (including a history of anxiety).
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 |
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Comparador de Placebo: PLACEBO
Placebo (normal saline) will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
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Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
Outros nomes:
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Outro: NEOSTIGMINE
intravenous neostigmine will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
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Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
Outros nomes:
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Experimental: SUGAMMADEX
intravenous sugammade will be administered following a period of muscle relaxation after which respiratory measurements will be obtained.
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Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
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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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Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
Prazo: during the 1-2 hours following reversal
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The change in breathing response to a decrease in inspired oxygen concentration, which equals the isocapnic ventilatory response to hypoxia.
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during the 1-2 hours following reversal
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Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
Prazo: 0-10 minutes following reversal
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The ventilatory response to a decrease in oxygen saturaytion of 80%
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0-10 minutes following reversal
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Eriksson LI, Sato M, Severinghaus JW. Effect of a vecuronium-induced partial neuromuscular block on hypoxic ventilatory response. Anesthesiology. 1993 Apr;78(4):693-9. doi: 10.1097/00000542-199304000-00012.
- Eriksson LI, Lennmarken C, Wyon N, Johnson A. Attenuated ventilatory response to hypoxaemia at vecuronium-induced partial neuromuscular block. Acta Anaesthesiol Scand. 1992 Oct;36(7):710-5. doi: 10.1111/j.1399-6576.1992.tb03550.x.
- Dahan A, Nieuwenhuijs D, Teppema L. Plasticity of central chemoreceptors: effect of bilateral carotid body resection on central CO2 sensitivity. PLoS Med. 2007 Jul 24;4(7):e239. doi: 10.1371/journal.pmed.0040239.
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 (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
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Distúrbios Respiratórios
- Insuficiência Respiratória
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Agentes colinérgicos
- Inibidores Enzimáticos
- Inibidores da colinesterase
- Parassimpaticomiméticos
- Neostigmina
Outros números de identificação do estudo
- P16.025
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
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Ensaios clínicos em Placebo
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University of OxfordHospital General Universitario Gregorio Marañon; Charite University, Berlin,... e outros colaboradoresAinda não está recrutandoPsicose | Psicose Resistente ao TratamentoEspanha, Reino Unido, Alemanha, Israel, Grécia, Itália, Holanda, Suíça