Sleep disturbances
Conditions
Interventions
tVNS group:Intraoperative transcutaneous electrical stimulation of the vagus nerve was performed.
Control group:Sham stimulation
Sponsors
The First Hospital Of Jiaxing
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~65 years old. 2. ASA level I-III; 3. Receive general anesthesia maintained only by sevoflurane and remifentanil. 4. Elective surgery with an expected operation time of 1-4 hours. 5. Preoperative PSQI score <=5 points (normal sleep quality). 6. Abdominal surgery or orthopedic surgery; 7. Signed informed consent form;
Exclusion criteria
Exclusion criteria: 1. Vagus neuropathy (diabetic autonomic neuropathy, history of vagus nerve sect); 2. Central nervous system diseases (such as epilepsy, sequelae of stroke, Parkinson's disease); 3. Sleep-related movement disorders (such as restless legs syndrome, periodic limb movement disorder); 4. Suffering from uncontrolled major mental disorders (such as major depression, bipolar disorder, schizophrenia); 5. Patients with suspected or suffering from sleep apnea syndrome. 6. Severe arrhythmias (such as atrial fibrillation, sinus brady=8); 9. Those who use sedatives, hypnotics or sleep-promoting drugs (including but not limited to benzodiazepines, zolpidem, melatonin and their receptor agonists) within one month before surgery. 10. Patients who have undergone surgery in the past month. 11. Emergency surgery; 12. Anatomical deformity of the ear (concha defect); 13. Chronic otitis media/ear skin breakage; 14. Those with cognitive dysfunction (Mini-Mental State Examination MMSE <24 points), or clinically diagnosed with mild cognitive impairment (MCI)/dementia; 15. Those who have been diagnosed with delirium by the Confusion Assessment Method (CAM). 16. Pregnancy/lactation; 17. Those who cannot complete the research evaluation due to < 6 years of formal education.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Richards-Campbell Sleep Questionnaire,RCSQ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively.;Types and measurement of analgesic drugs;Numeric Rating Scale, NRS;Anxiety and depression scores;Delirium, adverse reactions, nausea and vomiting, etc;Epworth Sleepiness Scale; | — |
Countries
China
Contacts
Public ContactTong Wu
The First Hospital of Jiaxing, Affiliated Hospital of JiaXing University
Outcome results
None listed