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NCT07813962

Dexmedetomidine Combined With Transcutaneous Vagus Nerve Stimulation (taVNS) Can Reduce the Incidence of PTSD in Trauma Patients After Surgery

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below.

  1. Recruitment opened
    • Start date changed from estimate of Sep 6, 2026 to Sep 12, 2026
    • Study sites: 0 to 1
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

One month after surgery, the incidence rate, symptom scores, and decrease amplitude of PTSD in both groups were assessed using CAPS-5
Timeframe: One month post-surgery

Secondary (4)

Pain intensity was evaluated utilizing the Visual Analogue Scale (VAS) at 24 and 48 hours, as well as 1 month postoperatively.
The incidence rates of delirium, nausea, and pruritus were documented within the first three days post-surgery.
NRS sleep assessment 1-3 days post-surgery
BAI anxiety score 1-3 days after surgery

Arms and interventions

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

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)

Drugs: Dexmedetomidine 0.1μg/kg/h

Devices: tavns

Sites

1 site in 1 country

  • Affiliated hospital of Nantong UniversityNantong, Jiangsu, China