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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The nasal spray group (Group D) :Dexmedetomidine hydrochloride nasal spray 100μg | Experimental | 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 control group (Group C):Placebo nasal spray 100μg | Placebo Comparator | The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine hydrochloride nasal spray | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative delirium (POD) within the first 3 days after surgery | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time from End of Surgery to Tracheal Extubation (Minutes) | 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]). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng LI | Contact | +86 13668169590 | lipengmazui@163.com | |
| Shaomao Jia | Contact | +86 13419213559 | 670979499@qq.com |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| Placebo | Drug | The control group (Group C) received a placebo as the test drug, administered as two sprays into each nostril, totalling 100 μg of placebo. |
|
| Duration of Post-Anesthesia Care Unit (PACU) Stay (Minutes) | 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 | Incidence of adverse events following administration of the investigational product. | From administration of the investigational product up to 7 days postoperatively. |
| Subjective sleep quality | 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 | 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 | 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 | 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) | 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. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |