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Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients. (Vnstep)

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Capital Medical University

Status

Enrolling

Conditions

Vagus Nerve Stimulation

Treatments

Device: Transauricular Vagal Nerve Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06421051
HX-B-2024016

Details and patient eligibility

About

Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients.

Enrollment

164 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing non-craniocerebral surgery under elective general anesthesia
  • Age ≥65 years old
  • American society of Aneshesiologists Grade I to III
  • Sign informed consent

Exclusion criteria

  • Patients who are expected to retain tracheal intubation after surgery
  • Disturbance of consciousness, mental disorder, inability to cooperate
  • Expected survival < 3 months
  • The estimated operation time is < 2 hours
  • The expected postoperative hospital stay is < 5 days

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

164 participants in 2 patient groups, including a placebo group

high-frequency vagus nerve electrical stimulation
Experimental group
Treatment:
Device: Transauricular Vagal Nerve Stimulation
low-frequency vagus nerve electrical stimulation
Placebo Comparator group
Treatment:
Device: Transauricular Vagal Nerve Stimulation

Trial contacts and locations

1

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Central trial contact

Ruquan Han, MD

Data sourced from clinicaltrials.gov

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