Postoperative Delirium (POD)
Conditions
Keywords
Dexmedetomidine Nasal Spray, Elderly (people aged 65 or more), Video-assisted thoracoscopic surgery (VATS), Lung resection procedures, Postoperative Delirium (POD)
Brief summary
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.
Interventions
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.
DRUGPlacebo
The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo.
Sponsors
Sichuan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative delirium (POD) within the first 3 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from End of Surgery to Tracheal Extubation (Minutes) | 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. |
| Duration of Post-Anesthesia Care Unit (PACU) Stay (Minutes) | 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. |
| Incidence of adverse events | From administration of the investigational product up to 7 days postoperatively. | Incidence of adverse events following administration of the investigational product. |
| Subjective sleep quality | 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. |
| NRS pain score | 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) |
| The severity of postoperative delirium | 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. |
| Duration of delirium | 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. |
| Duration of Postoperative Hospital Stay (Days) | 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. |
Contacts
CONTACTPeng LI
CONTACTShaomao Jia
Outcome results
None listed