Dexmedetomidine with taVNS to see if PTSD after trauma surgery can be reduced

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults aged 18-80 undergoing emergency trauma surgery to test a combination therapy of dexmedetomidine and transcutaneous vagus nerve stimulation (taVNS). Participants receive a dexmedetomidine infusion at 0.1 μg/kg/h alongside taVNS, with follow-up assessing PTSD symptoms up to one month postoperatively. The goal is to see if this approach dampens perioperative stress responses and reduces PTSD incidence compared with standard care. Outcomes will focus on PTSD-related measures, safety, and recovery parameters in the immediate postoperative period. The study is conducted at the Affiliated Hospital of Nantong University in Nantong, Jiangsu, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affiliated hospital of Nantong University
  Nantong, Jiangsu, China Recruiting

Study contacts

• Study coordinator: chaochao zhong, Doctor of Medicine
• Email: zhong249767626@163.com
• Phone: 15152460489

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.