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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Dexmedetomidine Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

Difference in scores of the State-Trait Anxiety Inventory-State (STAI-S)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Zeng, MD,Ph.D

CONTACT

[email protected]

8610-59976658

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Sep 2, 2026
Registry last updated: Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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