Anxiety, Dexmedetomidine
Conditions
Brief summary
This randomized clinical trial aims to evaluate the effect of preoperative use of dexmedetomidine nasal spray on improving perioperative anxiety levels in patients undergoing elective supratentorial tumor resection.
Interventions
DRUGDexmedetomidine
Patients will receive dexmedetomidine nasal spray in the ward on the night before surgery (before bedtime) and on the morning of surgery (about 1 - 2 hours before anesthesia induction). When administering the drug, the patient should sit upright with the head slightly forward, shake well before use and pre-pray to activate the device. The standard dose is 100μg (2 sprays in each nostril, 4 sprays in total, 25 μg per spray). For subjects older than 60 years or weighing less than 45 kg, the dose is adjusted to 75 μg (a total of 3 sprays, alternately sprayed into both nostrils, for example, 2 sprays in the left nostril and 1 spray in the right nostril, or vice versa).
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists physical status I to III * Scheduled to undergo elective supratentorial tumor resection * Preoperative STAI-S score \>45 * Obtain written informed consent
Exclusion criteria
* Severe hepatic or renal insufficiency * Allergy to dexmedetomidine or its excipients * Severe bradycardia (heart rate \<50 bpm), sick sinus syndrome, or second-/third-degree AV block without pacemaker * Use of α2-agonists, benzodiazepines, or other sedatives/analgesics within 24 hours preoperatively * History of alcohol, drug, or psychoactive substance dependence * Diagnosed or suspected obstructive sleep apnea syndrome * Nasal anatomical abnormalities, acute rhinitis, epistaxis, or other nasal conditions affecting drug administration * Pregnancy or lactation * Communication barriers, psychiatric disorders, or cognitive impairment precluding scale completion * Visual/hearing impairment or inability to read
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in scores of the State-Trait Anxiety Inventory-State (STAI-S) | Postoperative 5 day | Difference in scores of the State-Trait Anxiety Inventory-State (STAI-S) from the preoperative baseline (1 day before surgery) to the 5th day after surgery. |
Countries
China
Contacts
CONTACTMin Zeng, MD,Ph.D
PRINCIPAL_INVESTIGATORYuming Peng, MD,Ph.D
Beijing Tiantan Hospital
Outcome results
None listed