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Effect of perioperative transcutaneous auricular vagus nerve stimulation on postoperative sleep quality in elderly patients -- a prospective, randomized, controlled study

Effect of perioperative transcutaneous auricular vagus nerve stimulation on postoperative sleep quality in elderly patients -- a prospective, randomized, controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098678
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-03-16
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative sleep disturbance

Interventions

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 60~85 years old, diagnosed with gastric and colorectal tumors, gender is not limited; 2. Patients undergoing endotracheal intubation laparoscopic abdominal tumor resection under general anesthesia (stomach, colon, rectum); 3. The duration of the operation < 6 hours 4. The operation is expected to end before 6 p.m.; 5.18 kg/m^2<=BMI <=30 kg/m2 (body mass index = weight (kg) / height (m^2); 6. ASA classification (American Society of Anesthesiologists classification) I-III; 7. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Local skin infection and skin damage in the earnail area; 2. Patients who are illiterate or have severe visual or hearing impairment and are unable to communicate with physicians; 3. History of previous apnea or moderate to severe obstructive apnea syndrome; 4. Previous history of chronic insomnia or preoperative Pittsburgh Sleep Quality Index (PSQI) >=7 and/or Athens Insomnia Scale (AIS) >= 6; 5. Preoperative Mini- Mental State Examination (MMSE) score <= 23 points; 6. Patients with preoperative pain, using central analgesic drugs, opioid addiction and dependence; 7. Patients with a history of cognitive dysfunction or psychiatric disorder, or dementia or Parkinson's disease; 8. History of psychotropic drug abuse; 9. Patients with severe liver and kidney dysfunction; 10. Patients with pacemakers or patients with definite cardiac electrical conduction dysfunction.

Design outcomes

Primary

MeasureTime frame
Total sleep time of the night after operation(refer to the patient's sleep diary and the total sleep time recorded on the actigraphy);

Secondary

MeasureTime frame
Postoperative Pittsburgh sleep quality index (PSQI) score;Postoperative Athens Insomnia Scale (AIS) score;Sleep related indicators recorded by actigraphy after surgery;Postoperative Hamilton Depression Scale (HAMD) score;Postoperative Hamilton Anxiety Scale (HAMA) score;Postoperative recovery of gastrointestinal function;Postoperative pain;Postoperative nausea and vomiting;Intraoperative anesthesia related parameters;Health economic indicators;Postoperative inflammatory index;The number of patients in each group who received benzodiazepines and other hypnotics because insomnia after aperation;

Countries

China

Contacts

Public ContactLixin An

Beijing Friendship Hospital, Capital Medical University

anlixin8120@163.com+86 138 1024 8120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026