PTSD - Post Traumatic Stress DisorderNCT07813962
Dexmedetomidine Combined With Transcutaneous Vagus Nerve Stimulation (taVNS) Can Reduce the Incidence of PTSD in Trauma Patients After Surgery
A study testing Dexmedetomidine 0.1μg/kg/h and tavns in people with PTSD - Post Traumatic Stress Disorder and taVNS, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Emergency trauma surgery patients, due to the dual stress effects of sudden trauma events (such as car accidents, falls, engineering accidents) and surgical trauma, have a significantly higher incidence of post-traumatic stress disorder (PTSD) compared to the general population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, taVNS, Dexmedetomidine
- What is being tested?
- Dexmedetomidine 0.1μg/kg/h and tavns
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2026to 1 Dec 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80, of either gender, requiring emergency surgery due to trauma (such as car accidents, falls, engineering accidents, etc.).
- No confirmed PTSD before enrollment.
- The American Society of Anesthesiologists (ASA) physical status classification is divided into grades I-III (Grade I: healthy body and normal organ function; Grade II: mild comorbidities with good functional compensation; Grade III: severe comorbidities with limited mobility but able to cope with daily activities).
- Voluntarily sign the informed consent form and be able to cooperate with the 1-month postoperative follow-up assessment (including CAPS-5 interview, scale completion, etc.)
Who cannot join
- Patients with severe craniocerebral or spinal cord injury, compensatory phase of hemorrhagic shock, or severe cardiovascular and cerebrovascular issues such as second-degree or higher-degree atrioventricular block, and baseline heart rate <50 beats per minute.
- Hepatic and renal insufficiency (transaminase > 2 times the upper limit of normal, creatinine > 1.5 times the upper limit of normal), coagulation dysfunction (INR > 1.5), or history of alcohol abuse or drug dependence within the past 6 months.
- History of neuropsychiatric disorders (such as schizophrenia, bipolar disorder), previous PTSD history, or severe visual, auditory, or language impairments, making them unable to cooperate with scale assessments.
- Allergic to dexmedetomidine, or with damaged/infected skin at the tVNS stimulation site (cavity of the ear concha), or implanted with a cardiac pacemaker (contraindication to tVNS).
- Pregnant or lactating women, or those who plan to receive other PTSD interventions (such as psychotherapy, anti-anxiety medications) after surgery and may withdraw from follow-up midway.
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, 1 recruiting
- Recruiting
Affiliated hospital of Nantong University
Nantong, Jiangsu, 226001
Chao-Chao Zhong, M.D.;P.H.D, 15152460489, zhong249767626@163.com
About this study
Official title: Dexmedetomidine Combined With Transcutaneous Vagus Nerve Stimulation (taVNS) for the Prevention of Post-traumatic Stress Disorder (PTSD) in Patients Undergoing Emergency Trauma Surgery
Emergency trauma surgery patients, due to the dual stress effects of sudden trauma events (such as car accidents, falls, engineering accidents) and surgical trauma, have a significantly higher incidence of post-traumatic stress disorder (PTSD) compared to the general population. This disease, characterized by intrusive memories, avoidance behaviors, negative changes in cognitive emotions, and increased arousal, not only severely hinders patients' postoperative psychological recovery and reduces their quality of life, but may also prolong hospital stays, increase the risk of readmission, and impose a heavy medical and economic burden on families and society. Dexmedetomidine, as a highly selective α₂-adrenergic receptor agonist, possesses sedative, anxiolytic, analgesic, and sympatholytic effects. By regulating the locus coeruleus-norepinephrine system, it can alleviate perioperative stress responses, reduce postoperative anxiety and delirium incidence. In recent years, multiple studies both domestically and internationally have confirmed its potential to prevent PTSD by inhibiting the encoding and consolidation processes of trauma-related memories. In randomized clinical trials, administering dexmedetomidine during and after surgery has been shown to reduce the incidence of PTSD in trauma patients. However, when used alone, some patients still develop PTSD, indicating room for improvement in preventive efficacy. Additionally, there are risks of adverse reactions such as hypotension and bradycardia, which limit its application in certain populations.
As a non-invasive vagus nerve stimulation technique, transcutaneous vagus nerve stimulation (taVNS) exerts its effect by stimulating the vagus nerve branches in the cavum concha. It has the advantages of simple operation, high safety, and can be implemented during the perioperative period. It has been proven to regulate the stress response and emotional processing of the central nervous system, reduce stress response scores, and has the potential for perioperative analgesia. However, there is limited research on its early prevention after emergency trauma surgery, and no exploration of synergistic effects with dexmedetomidine. Currently, there is no clinical research on the use of dexmedetomidine combined with taVNS for the prevention of post-traumatic stress disorder (PTSD) in patients undergoing emergency trauma surgery at home and abroad. Existing research mostly focuses on single drugs or single neuroregulation techniques, and there are limitations such as small sample size, short follow-up time, and uncontrolled confounding factors such as perioperative pain and delirium, making it difficult to meet the clinical demand for efficient and safe PTSD prevention schemes.
- Being tested
- Dexmedetomidine 0.1μg/kg/h, tavns
- Keywords
- PTSD, tavns, Dexmedetomidine
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.1μg/kg/hDrug
During the period from the commencement of anesthesia to the conclusion of surgery, Group A received dexmedetomidine (specification: 200μg/2mL, diluted with normal saline to 50mL, resulting in a final concentration of 4μg/mL) administered intravenously at a maintenance dose of 0.1μg/kg/h
tavnsDevice
On the basis of the identical dexmedetomidine medication as Group A, Group B received additional taVNS intervention: after cleaning the skin of the cavum concha tympanicum of the subjects by trained and qualified medical staff, electrodes were pasted, and stimulation parameters were set at a frequency of 20Hz and a pulse width of 250μs, with fixed intensity stimulation (if the electrode fell off, it was re-pasted to make up for the duration; if the subject could not tolerate it, the intervention was terminated)
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Comparator: control group (Dexmedetomidine group) | Sham comparator | During the period from the commencement of anesthesia to the conclusion of surgery, Group A received dexmedetomidine (specification: 200μg/2mL, diluted with normal saline to 50mL, resulting in a final concentration of 4μg/mL) administered intravenously at a maintenance dose of 0.1μg/kg/h Receives: Drug: Dexmedetomidine 0.1μg/kg/h |
| Experimental: Case group (Dexmedetomidine combined with taVNS group) | Experimental | On the basis of the identical dexmedetomidine medication as Group A, Group B received additional taVNS intervention: after cleaning the skin of the cavum concha tympanicum of the subjects by trained and qualified medical staff, electrodes were pasted, and stimulation parameters were set at a frequency of 20Hz and a pulse width of 250μs, with fixed intensity stimulation (if the electrode fell off, it was re-pasted to make up for the duration; if the subject could not tolerate it, the intervention was terminated) Receives: Device: tavns |
What is being measured
The primary outcome is the main question the study is designed to answer.
One month after surgery, the incidence rate, symptom scores, and decrease amplitude of PTSD in both groups were assessed using CAPS-5
One month after surgery, a blinded evaluator assessed the incidence of PTSD in both groups using the CAPS-5 scale (based on DSM-5 criteria) (requiring the presence of 1 intrusion item + 1 avoidance item + 2 cognitive and emotional negative alterations + 2 arousal reaction symptoms, lasting for ≥1 month and affecting function). The CAPS-5 score (0-80 points, with higher scores indicating more severe symptoms) and the decrease in score compared to the preoperative baseline (less than 20 points, indicating no symptoms) were simultaneously recorded.
Measured: One month post-surgery
Secondary outcomes (4)
Pain intensity was evaluated utilizing the Visual Analogue Scale (VAS) at 24 and 48 hours, as well as 1 month postoperatively.
Measured: At 24/48 hours and 1 month post-surgery
The incidence rates of delirium, nausea, and pruritus were documented within the first three days post-surgery.
Measured: Within the first 3 days post-surgery
NRS sleep assessment 1-3 days post-surgery
Measured: Days 1-3 postoperatively
BAI anxiety score 1-3 days after surgery
Measured: Postoperative days 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start12 Sep 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaochao Zhong, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813962
- Sponsor's protocol ID
- 2026-K102-02
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Combined With Transcutaneous Vagus Nerve Stimulation (taVNS) for the Prevention of Post-traumatic Stress Disorder (PTSD) in Patients Undergoing Emergency Trauma Surgery
- ClinicalTrials.gov ID
- NCT07813962
- Acronym / sponsor ID
- 2026-K102-02
- Keywords
- PTSD, tavns, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 12 Sep 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 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.
Emergency trauma surgery patients, due to the dual stress effects of sudden trauma events (such as car accidents, falls, engineering accidents) and surgical trauma, have a significantly higher incidence of post-traumatic stress disorder (PTSD) compared to the general population. This disease, characterized by intrusive memories, avoidance behaviors, negative changes in cognitive emotions, and increased arousal, not only severely hinders patients' postoperative psychological recovery and reduces their quality of life, but may also prolong hospital stays, increase the risk of readmission, and impose a heavy medical and economic burden on families and society. Dexmedetomidine, as a highly selective α₂-adrenergic receptor agonist, possesses sedative, anxiolytic, analgesic, and sympatholytic effects. By regulating the locus coeruleus-norepinephrine system, it can alleviate perioperative stress responses, reduce postoperative anxiety and delirium incidence. In recent years, multiple studies both domestically and internationally have confirmed its potential to prevent PTSD by inhibiting the encoding and consolidation processes of trauma-related memories. In randomized clinical trials, administering dexmedetomidine during and after surgery has been shown to reduce the incidence of PTSD in trauma patients. However, when used alone, some patients still develop PTSD, indicating room for improvement in preventive efficacy. Additionally, there are risks of adverse reactions such as hypotension and bradycardia, which limit its application in certain populations.
As a non-invasive vagus nerve stimulation technique, transcutaneous vagus nerve stimulation (taVNS) exerts its effect by stimulating the vagus nerve branches in the cavum concha. It has the advantages of simple operation, high safety, and can be implemented during the perioperative period. It has been proven to regulate the stress response and emotional processing of the central nervous system, reduce stress response scores, and has the potential for perioperative analgesia. However, there is limited research on its early prevention after emergency trauma surgery, and no exploration of synergistic effects with dexmedetomidine. Currently, there is no clinical research on the use of dexmedetomidine combined with taVNS for the prevention of post-traumatic stress disorder (PTSD) in patients undergoing emergency trauma surgery at home and abroad. Existing research mostly focuses on single drugs or single neuroregulation techniques, and there are limitations such as small sample size, short follow-up time, and uncontrolled confounding factors such as perioperative pain and delirium, making it difficult to meet the clinical demand for efficient and safe PTSD prevention schemes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Comparator: control group (Dexmedetomidine group) | Sham comparator | Drug: Dexmedetomidine 0.1μg/kg/hDuring the period from the commencement of anesthesia to the conclusion of surgery, Group A received dexmedetomidine (specification: 200μg/2mL, diluted with normal saline to 50mL, resulting in a final concentration of 4μg/mL) administered intravenously at a maintenance dose of 0.1μg/kg/h |
| Experimental: Case group (Dexmedetomidine combined with taVNS group) | Experimental | Device: tavnsOn the basis of the identical dexmedetomidine medication as Group A, Group B received additional taVNS intervention: after cleaning the skin of the cavum concha tympanicum of the subjects by trained and qualified medical staff, electrodes were pasted, and stimulation parameters were set at a frequency of 20Hz and a pulse width of 250μs, with fixed intensity stimulation (if the electrode fell off, it was re-pasted to make up for the duration; if the subject could not tolerate it, the intervention was terminated) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-80, of either gender, requiring emergency surgery due to trauma (such as car accidents, falls, engineering accidents, etc.).
- No confirmed PTSD before enrollment.
- The American Society of Anesthesiologists (ASA) physical status classification is divided into grades I-III (Grade I: healthy body and normal organ function; Grade II: mild comorbidities with good functional compensation; Grade III: severe comorbidities with limited mobility but able to cope with daily activities).
- Voluntarily sign the informed consent form and be able to cooperate with the 1-month postoperative follow-up assessment (including CAPS-5 interview, scale completion, etc.)
Key exclusion criteria (5 listed)
- Patients with severe craniocerebral or spinal cord injury, compensatory phase of hemorrhagic shock, or severe cardiovascular and cerebrovascular issues such as second-degree or higher-degree atrioventricular block, and baseline heart rate <50 beats per minute.
- Hepatic and renal insufficiency (transaminase > 2 times the upper limit of normal, creatinine > 1.5 times the upper limit of normal), coagulation dysfunction (INR > 1.5), or history of alcohol abuse or drug dependence within the past 6 months.
- History of neuropsychiatric disorders (such as schizophrenia, bipolar disorder), previous PTSD history, or severe visual, auditory, or language impairments, making them unable to cooperate with scale assessments.
- Allergic to dexmedetomidine, or with damaged/infected skin at the tVNS stimulation site (cavity of the ear concha), or implanted with a cardiac pacemaker (contraindication to tVNS).
- Pregnant or lactating women, or those who plan to receive other PTSD interventions (such as psychotherapy, anti-anxiety medications) after surgery and may withdraw from follow-up midway.
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 |
|---|---|---|
| Dexmedetomidine 0.1μg/kg/hDuring the period from the commencement of anesthesia to the conclusion of surgery, Group A received dexmedetomidine (specification: 200μg/2mL, diluted with normal saline to 50mL, resulting in a final concentration of 4μg/mL) administered intravenously at a maintenance dose of 0.1μg/kg/h | Drug | Dexmedetomidine Comparator: control group (Dexmedetomidine group) |
| tavnsOn the basis of the identical dexmedetomidine medication as Group A, Group B received additional taVNS intervention: after cleaning the skin of the cavum concha tympanicum of the subjects by trained and qualified medical staff, electrodes were pasted, and stimulation parameters were set at a frequency of 20Hz and a pulse width of 250μs, with fixed intensity stimulation (if the electrode fell off, it was re-pasted to make up for the duration; if the subject could not tolerate it, the intervention was terminated) | Device | Experimental: Case group (Dexmedetomidine combined with taVNS group) |
Primary outcome
One month after surgery, the incidence rate, symptom scores, and decrease amplitude of PTSD in both groups were assessed using CAPS-5
Time frame: One month post-surgery
One month after surgery, a blinded evaluator assessed the incidence of PTSD in both groups using the CAPS-5 scale (based on DSM-5 criteria) (requiring the presence of 1 intrusion item + 1 avoidance item + 2 cognitive and emotional negative alterations + 2 arousal reaction symptoms, lasting for ≥1 month and affecting function). The CAPS-5 score (0-80 points, with higher scores indicating more severe symptoms) and the decrease in score compared to the preoperative baseline (less than 20 points, indicating no symptoms) were simultaneously recorded.
4 secondary outcomes
Pain intensity was evaluated utilizing the Visual Analogue Scale (VAS) at 24 and 48 hours, as well as 1 month postoperatively.
Time frame: At 24/48 hours and 1 month post-surgery
The incidence rates of delirium, nausea, and pruritus were documented within the first three days post-surgery.
Time frame: Within the first 3 days post-surgery
NRS sleep assessment 1-3 days post-surgery
Time frame: Days 1-3 postoperatively
BAI anxiety score 1-3 days after surgery
Time frame: Postoperative days 1-3
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 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 0.1μg/kg/h and tavns in people with PTSD - Post Traumatic Stress Disorder and taVNS, run by Affiliated Hospital of Nantong University 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 5 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: looking for participants now, as of the sponsor's last update on 17 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. Some participants in this study may receive a placebo. 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 chaochao zhong, Doctor of Medicine (15152460489, zhong249767626@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One month after surgery, the incidence rate, symptom scores, and decrease amplitude of PTSD in both groups were assessed using CAPS-5 (time frame: One month post-surgery). 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 17 Sep 2026.