- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03559504
Comparing EEG Patterns in Different Age Groups During General Anesthesia With Sevoflurane
Visão geral do estudo
Descrição detalhada
EEG is a powerful tool that refers to the recording of the brain's spontaneous electrical activity along the scalp and it can be used to measure voltage fluctuations which result from ionic current flows within neurons found in the brain.The electroencephalogram is increasingly used to measure anesthetic drug effect on the central nervous system.The use of electroencephalographic monitors has been proven to decrease drug consumption during anesthesia and to lead to a faster recovery from anesthesia. Recently, the use of the Bispectral Index® (BIS®) monitor (Aspect Medical Systems, Newton, MA) has been shown to decrease the incidence of intraoperative awareness. Depth of anesthesia is frequently assessed using electroencephalogram processing systems, such as BIS and M-Entropy® (Datex-Ohmeda, Helsinki, Finland). The use of these monitors has been claimed to allow more accurate drug administration which has the theoretical benefit of avoiding phases of too light or too profound anesthesia and the associated risks of hemodynamic instability. Inadequate general anesthesia caused by under dosage causes intraoperative awareness whereas prolonged anesthesia increases the risk of postoperative complications because of over dosage. The most important factor that contributes to the inadequate general anesthesia is the current limited ability to determine the level of awareness. In this study, the investigators want to analyze the raw EEG waves under general anesthesia using sevoflurane of MAC 1.0 for different age groups from 0 to 80 years old. The relation between concentration of 1.0 MAC sevoflurane and raw EEG states in different age groups is relatively unstudied. In this prospective randomized study the investigators want to know if there is any correlation of brain waves under general anesthesia in different age groups. Given that the brain rapidly develops and undergoes significant changes from childbirth into adulthood, anesthesia induced EEG oscillations in children might differ from those of adults, and could vary significantly with age. Characterizing the structure of the EEG in relation to age would help establish the foundations for age-appropriate monitoring of brain states during general anesthesia and sedation in children. The investigators aimed to examine the effects of age on the EEG during general anesthesia, with sevoflurane as the sole hypnotic agent.
After arrival in the operating room, an intravenous line will be inserted into a large forearm vein, and standard monitors will be applied. Each patient will be continuously monitored by a 3-lead electrocardiogram, noninvasive arterial pressure, pulse oximetry, and end-tidal carbon dioxide concentration.
The induction of anesthesia will be the same in all age groups and will consist of sufentanil 0.2-0.3mcg/kg or fentanyl 1-2 mcg/kg before intubation and 0.2 mg/kg cisatracurium to facilitate intubation. Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration. After tracheal intubation, patients will be ventilated with a tidal volume of 6-8 ml/kg and the respiratory rate will be adapted to obtain an end-tidal carbon dioxide concentration of 30-35 mmHg.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Zhejiang
-
Zhejiang, Zhejiang, China, 325027
- The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University and Yuying Children's Hospital of Wenzhou Medical University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients age between 0 to 80 years old
- American Society of Anesthesiologists (ASA) I or II scheduled for minor surgeries under general anesthesia lasting less than 2 hours each.
Exclusion Criteria:
- Potential subjects with any neurological or psychiatric disease
- Relative or absolute contraindication to sevoflurane including pregnancy by patient self-report
- Any recent prescription or illicit medication use will be excluded
- Patients with a history of any disabling central nervous or cerebrovascular disease
- Patients who had received central nervous system-active drugs
- Patients with poor quality data, most likely because of poor electrode contact.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Caso-somente
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Group 1
Infant period: 1 month-1 year old
|
Anesthesia will be induced by sevoflurane inhalation only with a tight-fitting facemask and a 4-l airflow of 100% oxygen.
Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration
|
Group 2
Toddler period:1-3 years old
|
Anesthesia will be induced by sevoflurane inhalation only with a tight-fitting facemask and a 4-l airflow of 100% oxygen.
Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration
|
Group 3
Preschool age period:3-6 years old
|
Anesthesia will be induced by sevoflurane inhalation only with a tight-fitting facemask and a 4-l airflow of 100% oxygen.
Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration
|
Group 4
School age period:7-18 years old
|
Anesthesia will be induced by sevoflurane inhalation only with a tight-fitting facemask and a 4-l airflow of 100% oxygen.
Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration
|
Group 5
Adults:18-65 years old
|
Anesthesia will be induced by sevoflurane inhalation only with a tight-fitting facemask and a 4-l airflow of 100% oxygen.
Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration
|
Group 6
Elderly:65-80 years old
|
Anesthesia will be induced by sevoflurane inhalation only with a tight-fitting facemask and a 4-l airflow of 100% oxygen.
Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Electroencephalography among various ages.
Prazo: The experiment will be carried out for 10 mins after induction of anesthesia and before beginning of the surgery.
|
Monitoring the raw EEG changes among various ages.
The raw EEG waves of each patient will be analyzed and the results will be compared among the groups.
The investigators want to see if there is any difference of the EEG wave among the 6 groups under 1.0 MAC sevoflurane.
|
The experiment will be carried out for 10 mins after induction of anesthesia and before beginning of the surgery.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Morphology of electroencephalogram during 1.0 (MAC) Minimum Alveolar Concentration sevoflurane
Prazo: While the raw EEG wave is being recorded for a period of 10 mins, the investigators will adjust the concentration of sevoflurane bringing it to 1.0 MAC.
|
The investigators will analyze raw EEG waves from 0 year old to 80 years old.
The subjects will be divided into 6 groups according to their respective age.
Sevoflurane will be maintained at 1.0 MAC for each age groups.
|
While the raw EEG wave is being recorded for a period of 10 mins, the investigators will adjust the concentration of sevoflurane bringing it to 1.0 MAC.
|
Colaboradores e Investigadores
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SAHoWMU-CR2017-03-216
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
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 Sevoflurane Inhal Soln
-
Uptown Eye SpecialistsDesconhecidoPterígio | Hemorragia subconjuntival
-
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical...Concluído
-
American University of Beirut Medical CenterConcluídoMiastenia grave | Ocular Miastenia GravisLíbano
-
University of the Incarnate WordGuardion Health Sciences, Inc.RetiradoGlaucoma | Glaucoma de Ângulo Aberto | Olho GlaucomaEstados Unidos
-
Yan LaiConcluído
-
Uptown Eye SpecialistsConcluídoCirurgia de catarata | Hemorragia subconjuntivalCanadá
-
Wills EyeRecrutamentoDescolamento Retiniano Regmatogênico | Vitreorretinopatia proliferativaEstados Unidos
-
University of Southern CaliforniaRescindidoFusão da Coluna, Região LombarEstados Unidos
-
XiaoXi LinDesconhecidoHemangioma InfantilChina