- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03406403
A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.
Visão geral do estudo
Status
Condições
Descrição detalhada
Rapid recovery from neuroanesthesia and early neurological examination are desirable in most cases.(1)Although, Systemic and cerebral hemodynamic changes caused by extubation and emergence from anesthesia may endanger neurosurgical patients and increase the risk of postoperative intracranial hemorrhage and cerebral edema and may even result in the requirement of reoperation.(2) During this phase, heart rate and arterial blood pressure increase leading to increases in cerebral blood flow and intracranial pressure.(3) Some studies have reported such hemodynamic effects in up to 50% of patients after supratentorial craniotomy.(4,5) Replacing the endotracheal tube (ETT) with laryngeal mask airway (LMA) prior to emergence from anesthesia is safe and effectively reduces the cardiovascular response.(6) The potential protective benefit of this approach has not yet been demonstrated for awakening neurosurgery patients, however.
Magnesium is the forth most abundant cation in the body and the second most abundant intracellular cation. It activates many of the enzyme systems.(7) Magnesium sulphate inhibits catecholamines release from adrenergic nerve terminals and from adrenal medulla, through blocking N-type of Ca-channel at peripheral sympathetic nerve ending so it is used to decrease the adverse cardiovascular effects during larygeoscopy and endotracheal intubation.(8) But its role in attenuating stress response during extubation is not well studied and need more research.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Cairo, Egito, 11451
- Ahmed Abdalla Mohamed
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- ASA physical status I, II.
- Ages between 18 and 60 years.
- Body mass index (BMI) < 30.
- Elective surgery
Exclusion Criteria:
- Patients have cardiovascular, pulmonary, renal, hepatic and endocrine diseases.
- Patients have any degree of disturbed conscious level.
- Ages <18 or >60 years.
- BMI >30.
- Patients have history of allergy to Magnesium sulphate.
- Patients have uncontrolled hypertension during preoperative assessment.
- Patients have risk of aspiration (eg. hiatus hernia)
- Patients have difficult airway management during intubation with direct laryngoscope or time of intubation >30 seconds.
- Failed ventilation with LMA.
- Emergency surgery.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Laryngeal mask airway group
20 slips of papers will be taken and labeled as group L (LMA) These slips will be placed in an envelope and one slip will be raised for each patient.
|
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
|
Comparador Ativo: Magensium sulphate group
20 slips of papers will be taken and labeled as group M (Mgso4) These slips will be placed in an envelope and one slip will be raised for each patient
|
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
|
Comparador Ativo: Control group (closure of anesthetics)
20 slips of papers will be taken and labeled as group C (Control) These slips will be placed in an envelope and one slip will be raised for each patient.
|
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Mean arterial blood presure
Prazo: 5 minutes from closure of anesthetics until 15 minutes after extubation
|
Total dose of nitroglycerin needed in each group to maintain mean blood pressure within 20 % of basal line.
|
5 minutes from closure of anesthetics until 15 minutes after extubation
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Intracranial pressure Measurement
Prazo: 1 and 10 minutes after extubation.
|
Intracranial pressure will be measured at these moments: basal line preinduction, end of surgery, before extubation and 1, 10 minutes after extubation.
|
1 and 10 minutes after extubation.
|
Quality of extubation
Prazo: Time Onset of cough immediately after extubation
|
Qualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale
|
Time Onset of cough immediately after extubation
|
Level of consciousness
Prazo: 5 and 15 minutes after extubation
|
consciousness level will be recorded based on Ramasy score scale at 5 and 15 minutes after extubation, using the following indices
|
5 and 15 minutes after extubation
|
End of surgery and extubation
Prazo: intraoperative
|
Time interval between end of surgery and extubation in each group
|
intraoperative
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hamed Fathy, M.S, Cairo University
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
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Neoplasias
- Neoplasias por local
- Neoplasias Cerebrais
- Neoplasias do Sistema Nervoso Central
- Neoplasias do Sistema Nervoso
- Neoplasias Supratentoriais
- Efeitos Fisiológicos das Drogas
- Depressores do Sistema Nervoso Central
- Anestésicos
Outros números de identificação do estudo
- N-102-2017
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Laryngeal mask airway
-
Ann & Robert H Lurie Children's Hospital of ChicagoConcluídoCriançasEstados Unidos
-
Zonguldak Bulent Ecevit UniversityConcluídoAumento da pressão intracraniana | Dispositivo de Via Aérea Supraglótica | Diâmetro da bainha do nervo ópticoPeru
-
Dokuz Eylul UniversityConcluído
-
Krankenhaus BruneckMedical University InnsbruckConcluídoParada cardiopulmonarItália
-
Bezmialem Vakif UniversityConcluídoComplicação das Vias Aéreas da Anestesia | Aspiração das Vias Aéreas | Complicação da Anestesia | Lesão do Esôfago | Eficiência das Vias Aéreas Supraglóticas | Ergonomia Endoscópica | CPRE Gestão das Vias AéreasPeru
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Concluído
-
National University Hospital, SingaporeConcluído
-
China Medical University HospitalDesconhecido
-
Johnson & Johnson Vision Care, Inc.Rescindido