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

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07801014
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Dexmedetomidine

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexmedetomidine — DRUG
    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 Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Dexmedetomidine nasal spray combined with routine perioperative management
    Patients in this group will receive dexmedetomidine nasal spray in the ward on the night before surgery and on the morning of surgery.The standard dose is 100μg. For subjects older than 60 years or weighing less than 45 kg, the dose is adjusted to 75 μg. Patients also receive the same routine perioperative management as the control group.
  • No Intervention: Routine perioperative management
    Patients in this group do not receive any nasal spray intervention. Patients receive routine perioperative management.

Primary Outcome Measure

Difference in scores of the State-Trait Anxiety Inventory-State (STAI-S) [ Time Frame: Postoperative 5 day ]

Central Contacts

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