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The Impact of Dexmedetomidine Nasal Spray on Perioperative Anxiety in Neurosurgical Patients

NCT07801014 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-09-15
Last updated
2026-09-02

Condition(s) studied

AnxietyDexmedetomidine

Investigational drug(s) / intervention(s)

Dexmedetomidine →

Dexmedetomidine: 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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Beijing Tian Tan Hospital, Capital Medical University Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07801014 on ClinicalTrials.gov ↗ ← All trials in China