Dexmedetomidine Nasal Spray on Postoperative Delirium in Elderly Thoracoscopic Lung Resection Patients
6 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
264
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Peng LI
- Número de teléfono: +86 13668169590
- Correo electrónico: lipengmazui@163.com
Copia de seguridad de contactos de estudio
- Nombre: Shaomao Jia
- Número de teléfono: +86 13419213559
- Correo electrónico: 670979499@qq.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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 placebos: 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.
|
The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The incidence of postoperative delirium (POD) within the first 3 days after surgery
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time from End of Surgery to Tracheal Extubation (Minutes)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
23 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de mayo de 2026
Última verificación
1 de marzo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SPPH2025585
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .