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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• The incidence of postoperative delirium (POD) within the first 3 days after surgery [Срок оценки: postoperative days 1 through 3]

Вторичные конечные точки (8)

• Time from End of Surgery to Tracheal Extubation (Minutes) [Срок оценки: 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) [Срок оценки: From patient admission to the PACU (immediately post-surgery) until PACU discharge, assessed up to 24 hours after PACU admission.]
• Incidence of adverse events [Срок оценки: From administration of the investigational product up to 7 days postoperatively.]
• Subjective sleep quality [Срок оценки: postoperative days 1 through 3]
• NRS pain score [Срок оценки: Before discharge from the PACU and on postoperative days 1 through 3.]
• The severity of postoperative delirium [Срок оценки: postoperative days 1 through 3]
• Duration of delirium [Срок оценки: Time from delirium onset to resolution, assessed up to 7 days postoperatively.]
• Duration of Postoperative Hospital Stay (Days) [Срок оценки: From the day of surgery until formal hospital discharge, assessed up to 30 days after surgery.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07579806 · SPPH2025585

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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