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Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Thoracoscopic Lung Resection Patients

6 de maio de 2026 atualizado por: Peng Li, Sichuan Provincial People's Hospital

The Effect of Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Lung Resection

This clinical trial is designed to observe the effect of dexmedetomidine nasal spray on the incidence of postoperative delirium in elderly patients undergoing thoracoscopic lung resection. Eligible elderly patients scheduled for thoracoscopic lung resection will be randomly divided into two groups: the dexmedetomidine group will receive dexmedetomidine hydrochloride nasal spray, while the placebo group will be administered an equivalent volume of placebo nasal spray. The primary outcome is the incidence of postoperative delirium within 3 days after surgery. Secondary outcomes include the severity and duration of delirium, as well as postoperative pain, subjective sleep quality, and the incidence of adverse events, which will be compared between the two groups to evaluate the safety and efficacy of dexmedetomidine nasal spray.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

264

Estágio

  • Fase 4

Contactos e Locais

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Contato de estudo

Estude backup de contato

  • Nome: Shaomao Jia
  • Número de telefone: +86 13419213559
  • E-mail: 670979499@qq.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status II-III.
  • Age ≥ 65 years, with no gender restriction.
  • Patients scheduled for elective thoracoscopic lung resection under general anesthesia, with an expected operative duration of 1-4 hours.
  • Body mass index (BMI) between 18 kg/m² and 30 kg/m².

Exclusion Criteria:

  • Known hypersensitivity to dexmedetomidine hydrochloride or any of the excipients in the investigational product.
  • Pre-existing nasal conditions, nasal surgery, or nasal allergies that may significantly impair nasal drug absorption (e.g., chronic nasal congestion, rhinorrhea, epistaxis, nasal anatomical abnormalities, or mucosal pathology affecting absorption).
  • History of cranial trauma.
  • Pre-existing diagnosis or clinical suspicion of neurocognitive impairment, defined as a Mini-Mental State Examination (MMSE) score < 24.
  • History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
  • History of alcohol or substance abuse/dependence.
  • Left ventricular ejection fraction < 30%; sick sinus syndrome; severe sinus bradycardia (< 50 bpm); or second- or higher-degree atrioventricular block without permanent pacemaker implantation.
  • History of myocardial infarction, unstable angina, severe cardiac arrhythmia, or decompensated cardiac insufficiency.
  • Asthma, emphysema, chronic bronchitis, or chronic obstructive pulmonary disease (COPD) considered inappropriate for study participation by the investigator.
  • Severe hepatic impairment (Child-Pugh Class C).
  • Severe renal dysfunction requiring preoperative dialysis.
  • Inability to provide valid informed consent due to cultural background, language barrier, or cognitive impairment.
  • Refusal to sign the informed consent form.
  • Other conditions deemed inappropriate for study participation by the investigator.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: The nasal spray group (Group D) ：Dexmedetomidine hydrochloride nasal spray 100μg
In the nasal spray group (Group D), the investigational product is dexmedetomidine hydrochloride nasal spray with a strength of 25 μg per spray. Two sprays will be administered into each nostril, resulting in a total dexmedetomidine dose of 100 μg.
Medicamento: Dexmedetomidine hydrochloride nasal spray
The nasal spray group (Group D) trial medication specification is dexmedetomidine hydrochloride nasal spray at 25μg per spray. Two sprays are administered into each nostril, totalling 100μg of dexmedetomidine.
Comparador de Placebo: The control group (Group C)：Placebo nasal spray 100μg
The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.
Medicamento: Placebo
The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The incidence of postoperative delirium (POD) within the first 3 days after surgery
Prazo: postoperative days 1 through 3
Patients will be assessed twice daily using the 3-Minute Delirium Assessment Scale (3D-CAM) on postoperative days 1 through 3.
postoperative days 1 through 3

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Time from End of Surgery to Tracheal Extubation (Minutes)
Prazo: From the immediate end of surgery until successful tracheal extubation, assessed up to 2 hours after surgery completion (prior to discharge from the Post-Anesthesia Care Unit [PACU]).
The time interval, measured in minutes, between the surgeon's confirmed end of surgery (defined as completion of final wound closure) and complete removal of the tracheal tube from the patient's airway, documented via the official electronic anesthesia record.
From the immediate end of surgery until successful tracheal extubation, assessed up to 2 hours after surgery completion (prior to discharge from the Post-Anesthesia Care Unit [PACU]).
Duration of Post-Anesthesia Care Unit (PACU) Stay (Minutes)
Prazo: From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.
The time interval, measured in minutes, between two standardized, timestamped endpoints: 1. Start point: The time of patient admission to the PACU, defined as the time when the patient is transferred into the PACU and connected to standard vital sign monitoring; 2. End point: The time of patient discharge from the PACU, defined as the time when the patient physically exits the PACU after meeting institutional discharge criteria. Data is prospectively documented in the official electronic anesthesia/PACU medical record.
From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.
Incidence of adverse events
Prazo: From administration of the investigational product up to 7 days postoperatively.
Incidence of adverse events following administration of the investigational product.
From administration of the investigational product up to 7 days postoperatively.
Subjective sleep quality
Prazo: postoperative days 1 through 3
Patient-reported subjective sleep quality, assessed daily using the 11-point Numerical Rating Scale (NRS, 0 = best sleep, 10 = worst sleep) on postoperative days 1-3.
postoperative days 1 through 3
NRS pain score
Prazo: Before discharge from the PACU and on postoperative days 1 through 3.
Pain score will be assessed using the Numerical Rating Scale (NRS) before discharge from the post-anesthesia care unit (PACU) and daily on postoperative days 1-3. (0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain)
Before discharge from the PACU and on postoperative days 1 through 3.
The severity of postoperative delirium
Prazo: postoperative days 1 through 3
Delirium severity will be assessed using the Memorial Delirium Assessment Scale (MDAS) in patients with positive delirium on postoperative days 1-3. The MDAS consists of 10 items with a total score of 30; the severity of delirium is defined as the maximum MDAS score obtained during postoperative days 1-3.
postoperative days 1 through 3
Duration of delirium
Prazo: Time from delirium onset to resolution, assessed up to 7 days postoperatively.
The period commencing from the day delirium was first assessed as positive until delirium was assessed as negative or the patient was discharged.
Time from delirium onset to resolution, assessed up to 7 days postoperatively.
Duration of Postoperative Hospital Stay (Days)
Prazo: From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.
Defined as the total number of calendar days from the day of index surgery to the day of hospital discharge. Discharge is defined as the time when the patient is formally discharged and physically leaves the hospital facility, recorded in the electronic hospital medical record.
From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sichuan Provincial People's Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

23 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de maio de 2026

Primeira postagem (Real)

12 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de março de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SPPH2025585

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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