Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Opioid Consumption in Patients Undergoing Major Abdominal Surgery
NCT ID: NCT07260266
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
108 participants
INTERVENTIONAL
2026-01-01
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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transcutaneous vagus nerve stimulation(taVNS)
Patients received taVNS treatment immediately upon entering the AICU, with sessions occurring every 2 hours. A specialized taVNS stimulator device was used, and the left ear was cleaned with an alcohol swab or wet tissue before inserting an earplug with electrode contacts into the left ear, ensuring a snug fit. A second earplug was inserted into the right ear. The stimulation parameters were set as follows: continuous wave, frequency 20 Hz, pulse width 200 μs. Each treatment session lasted for 30 minutes.
Transcutaneous auricular vagus nerve stimulation
Patients received taVNS treatment immediately upon entering the AICU, with sessions occurring every 2 hours. A specialized taVNS stimulator device was used, and the left auricle was cleaned with an alcohol swab or wet tissue before inserting an earplug with electrode contacts into the left ear, ensuring a snug fit. A second earplug was inserted into the right ear. The stimulation parameters were set as follows: continuous wave, frequency of 20 Hz, and pulse width of 200 μs. Each treatment session lasted for 30 minutes.
Sham-stimulation
The treatment protocol was identical to that of the taVNS group. Electrodes were placed on the left auricle. After the device was activated, it either did not deliver any current or only emitted a brief sub-threshold current to simulate the sensation of device activation, without producing continuous neural stimulation.
Sham Transcutaneous auricular vagus nerve stimulation
The treatment protocol was identical to that of the taVNS group. Electrodes were placed on the left auricle. After the device was turned on, it either did not output any current or only delivered a brief sub-threshold current to simulate the sensation of the device being activated, without producing continuous neural stimulation.
Interventions
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Transcutaneous auricular vagus nerve stimulation
Patients received taVNS treatment immediately upon entering the AICU, with sessions occurring every 2 hours. A specialized taVNS stimulator device was used, and the left auricle was cleaned with an alcohol swab or wet tissue before inserting an earplug with electrode contacts into the left ear, ensuring a snug fit. A second earplug was inserted into the right ear. The stimulation parameters were set as follows: continuous wave, frequency of 20 Hz, and pulse width of 200 μs. Each treatment session lasted for 30 minutes.
Sham Transcutaneous auricular vagus nerve stimulation
The treatment protocol was identical to that of the taVNS group. Electrodes were placed on the left auricle. After the device was turned on, it either did not output any current or only delivered a brief sub-threshold current to simulate the sensation of the device being activated, without producing continuous neural stimulation.
Eligibility Criteria
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Inclusion Criteria
* ASA physical status classification I-III
* Scheduled for elective major abdominal surgery under general anesthesia, with postoperative admission to the AICU for monitoring
* Anticipated duration of stay in the AICU is approximately 24 hours
Exclusion Criteria
* Severe arrhythmias or implanted electronic devices such as pacemakers;
* Skin lesions, infections, or deformities at the site of external ear stimulation;
* Long-term preoperative use of opioid medications or sedatives;
* Allergy to study-related medications;
18 Years
85 Years
ALL
No
Sponsors
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Affiliated Hospital of Jiaxing University
OTHER
Responsible Party
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Qing-he Zhou
Clinical Professor
Central Contacts
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Other Identifiers
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2025-LP-778
Identifier Type: -
Identifier Source: org_study_id