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- Ensaio Clínico NCT07569614
Comparative Effects of Remimazolam Tosylate and Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Surgery.
Comparative Effects of Remimazolam Tosylate and Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial
Postoperative delirium (POD) is a common acute brain dysfunction in the perioperative period, characterized by acute fluctuations in attention, consciousness, and cognition, typically occurring early after surgery. POD is closely associated with prolonged hospital stay, increased complications, delayed recovery, and higher mortality .
POD has multifactorial risk factors spanning preoperative, intraoperative, and postoperative phases. Its pathophysiology involves neuroinflammation, oxidative stress, blood-brain barrier dysfunction, and neurotransmitter imbalance . Advanced age, baseline cognitive impairment, infection, and malnutrition increase POD risk . Intraoperative hypotension, benzodiazepine exposure, and other anesthetic factors may also contribute .
Elderly patients have higher anesthesia risk due to age-related physiological decline. Cardiovascular reserve decreases with age, causing hemodynamic instability, especially during one-lung ventilation in thoracoscopic surgery . Among patients over 70 undergoing thoracoscopic lobectomy, 35.7% develop pulmonary complications; ASA grade ≥III, one-lung ventilation time, smoking history, and COPD are independent risk factors . Additionally, reduced hepatic and renal function slow anesthetic metabolism, increasing drug accumulation and delayed emergence .
Video-assisted thoracoscopic surgery (VATS) offers reduced trauma, faster recovery, and lower complication rates compared to open surgery . VATS shows clinical value in lung cancer and mediastinal tumors . Uniportal VATS allows faster recovery of pulmonary function (VC, FVC, TLC) and lower inflammatory markers (CRP, PCT, TNF-α) . However, caution is needed in elderly patients .
Despite reduced surgical trauma, elderly VATS patients may still develop POD. Anesthetic drugs, surgical stress, poor pain management, and neuroinflammation are key contributing factors . Therefore, optimizing perioperative anesthesia, maintaining hemodynamic stability, and reducing unnecessary sedative-analgesic loads are important strategies to lower POD risk.
Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with advantages in sedation, analgesia, and neuroprotection . It activates central α2-receptors, causing hyperpolarization of noradrenergic neurons and reducing norepinephrine release, producing sympatholytic effects without significant respiratory depression . It also has anti-inflammatory properties that may help prevent POD . Perioperative dexmedetomidine may reduce POD risk by alleviating stress, improving sleep-like sedation, and reducing opioid requirements . However, it can cause hypotension and bradycardia, requiring careful dosing in elderly patients .
Remimazolam tosilate is a newer ultra-short-acting benzodiazepine with rapid onset, fast metabolism, and mild circulatory depression. Its potential advantages in elderly and hemodynamically compromised patients are increasingly recognized, but its effect on POD remains inconclusive.
In summary, elderly VATS patients are at high risk for POD. Dexmedetomidine has preventive evidence but is limited by hypotension and bradycardia. Remimazolam may offer a smoother sedation alternative, but direct comparative evidence is lacking. This study aims to compare remimazolam versus dexmedetomidine on POD and perioperative recovery, providing evidence for individualized anesthesia management in elderly VATS patients.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Yunnan
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Kunming, Yunnan, China, 6500000
- First Affiliated Hospital of Kunming Medical University Kunming
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age ≥ 60 years;
- BMI: 18.5-23.9 kg/m²;
- ASA grade II-III;
- Preoperative MMSE score ≥ 25;
- Signed informed consent before surgery.
Exclusion Criteria:
- Recent history of sedative, analgesic, or opioid use;
- Severe hypertension or significant hepatic or renal insufficiency;
- Allergy to the study medications;
- Alzheimer's disease or acute phase of mental illness;
- History of chronic pain or receipt of analgesic therapy;
- Hearing/visual impairment with communication difficulties.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Dexmedetomidine grop(Group D):
received a loading dose of dexmedetomidine at 0.67 μg/kg 10 minutes before surgery, followed by continuous infusion at 0.4 μg/kg/h until 30 minutes before the end of surgery.
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Dexmedetomidine grop(Group D):received a loading dose of dexmedetomidine at 0.67 μg/kg 10 minutes before surgery, followed by continuous infusion at 0.4 μg/kg/h until 30 minutes before the end of surgery.
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Experimental: Remimazolam besylate grop (Group R)
received remimazolam besylate at 0.2 mg/kg during the induction of anesthesia, followed by continuous infusion at 0.3-0.5 mg/kg/h until 30 minutes before the end of surgery.
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Remimazolam besylate grop (Group R):received remimazolam besylate at 0.2 mg/kg during the induction of anesthesia, followed by continuous infusion at 0.3-0.5 mg/kg/h until 30 minutes before the end of surger
|
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Comparador Ativo: Normal Saline Group(Group N)
received an equivalent volume of normal saline.
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Normal Saline Group (Group N) received an equivalent volume of normal saline.
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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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Incidence of delirium at 30 minutes postoperatively and on postoperative days 1-3
Prazo: 30 minutes postoperatively and on postoperative days 1-3
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POD assessed with the 3-minute Diagnostic Interview for CAM (3D-CAM) at 30 min after surgery and on postoperative days 1-3.
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30 minutes postoperatively and on postoperative days 1-3
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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
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Complicações pós-operatórias
- Processos Patológicos
- Confusão
- Manifestações Neurocomportamentais
- Distúrbios Neurocognitivos
- Delírio
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Delírio de emergência
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Preparações farmacêuticas
- Azoles
- Imidazoles
- Soluções cristalóides
- Soluções isotônicas
- Soluções
- Dexmedetomidina
- Solução salina
Outros números de identificação do estudo
- (2025)Ethical Review L No.80
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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