Can a sedative plus ear stimulation stop PTSD before it starts?
NCT ID NCT07813962
First seen Sep 10, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
People who need emergency surgery after a traumatic event like a car crash or fall face a higher risk of developing post-traumatic stress disorder. This trial tests whether giving the sedative dexmedetomidine during surgery, with or without adding a non-invasive ear stimulation called taVNS, can lower that risk. Researchers will enroll 300 adults and check for PTSD symptoms one month later, along with pain, sleep, and anxiety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexmedetomidine combined with transcutaneous vagus nerve stimulation (taVNS)
- What this could lead to
- If it works, this could offer a way to prevent PTSD in people who have just been through a traumatic injury and emergency surgery.
- What could go wrong
- The trial is early and the combination has not been tested together before, so it may not prevent PTSD better than existing approaches. Dexmedetomidine can cause low blood pressure and slow heart rate, and taVNS may not add benefit.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18-80, of either gender, requiring emergency surgery due to trauma (such as car accidents, falls, engineering accidents, etc.). 2. No confirmed PTSD before enrollment. 3. 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). 4. 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.) Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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). 5. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated hospital of Nantong University
RECRUITINGNantong, Jiangsu, 226001, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Mini-Dose drug combo rescue Post-Surgery sleep for sleep apnea patients?
- Can a nasal spray calm nerves before brain surgery?
- Could a common sedative shield aging brains from Post-Surgery delirium?
- Can a single day of brain stimulation plus a drug ease PTSD?
- One-Day brain zaps plus antibiotic could rewire PTSD in first responders
- Virtual reality could open doors to trauma therapy