AnxietyNCT07801014
The Impact of Dexmedetomidine Nasal Spray on Perioperative Anxiety in Neurosurgical Patients
A study testing Dexmedetomidine in people with Anxiety and Dexmedetomidine, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anxiety, Dexmedetomidine
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
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.
- Conditions
- Anxiety, Dexmedetomidine
- Being tested
- Dexmedetomidine
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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 group | Role | What they receive |
|---|---|---|
| Dexmedetomidine nasal spray combined with routine perioperative management | Active comparator | 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. Receives: Drug: Dexmedetomidine |
| Routine perioperative management | No intervention | Patients in this group do not receive any nasal spray intervention. Patients receive routine perioperative management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Yuming Peng, MD,Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801014
- Sponsor's protocol ID
- 20260828
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dexmedetomidine Nasal Spray on Perioperative Anxiety in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT07801014
- Acronym / sponsor ID
- 20260828
- Conditions
- Anxiety, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine nasal spray combined with routine perioperative management | Active comparator | Drug: DexmedetomidinePatients 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. |
| Routine perioperative management | No intervention | –Patients in this group do not receive any nasal spray intervention. Patients receive routine perioperative management. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatients 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). | Drug | Dexmedetomidine nasal spray combined with routine perioperative management |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuming Peng, MD,Ph.D principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Anxiety and Dexmedetomidine, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Zeng, MD,Ph.D (8610-59976658, fly800727@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in scores of the State-Trait Anxiety Inventory-State (STAI-S) (time frame: Postoperative 5 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.