ClinicalTrials.gg
Not yet recruitingNCT07801014Updated Sep 2, 2026

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

An interventional study of Dexmedetomidine in Anxiety and Dexmedetomidine, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Anxiety
  • Dexmedetomidine

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03

In context

Anxiety Disorders Unverified

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 114 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 490 studies on the registry; 294 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • physical status I to III
  • Scheduled to undergo elective supratentorial tumor resection
  • Preoperative STAI-S score >45
  • Obtain written

Exclusion criteria

Exclusion Criteria:

  • Severe hepatic or renal insufficiency
  • Allergy to dexmedetomidine or its
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
114 participants (estimated)

Study 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.

    Drug: Dexmedetomidine

  • No intervention
    Routine perioperative management

    Patients in this group do not receive any nasal spray intervention. Patients receive routine perioperative management.

Interventions

  • 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).

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Postoperative 5 day

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for May 2028, 20 months later.

Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 20 months is above that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2026
First posted
Sep 2, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
May 31, 2028
CompletionEst.
May 31, 2028
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07801014
Responsible party
Yuming Peng (Deputy chief of Department of Anesthesiology, Beijing Tiantan Hospital) — Principal investigator
First posted
Sep 2, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
May 31, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Min Zeng, MD,Ph.D
Contact
fly800727@163.com
8610-59976658
Yuming Peng, MD,Ph.D
principal investigator · Beijing Tiantan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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