Auricular Vagus Nerve Stimulation to Prevent Nausea and Vomiting After Surgery in High-Risk Patients

Auricular Vagus Nerve Stimulation Guided by a Risk Prediction Model for the Prevention of Postoperative Nausea and Vomiting: A Randomized Controlled Study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600116420

Enrollment

Unknown

Registered

2026-01-09

Start date

2026-01-10

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Postoperative Nausea and Vomiting

Interventions

Auricular vagus nerve stimulation group:Auricular vagus nerve stimulation (aVNS)

Sham transcutaneous auricular stimulation:Sham stimulation

PONV prediction model development cohort:No

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Part 1: 1. Adult patients scheduled for elective surgery under general anesthesia; 2. Age >=18 years, either sex; 3. ASA physical status I–III; 4. Identified as high risk for postoperative nausea and vomiting based on a validated risk prediction model; 5. Provided written informed consent. Part 2: 1. Age > 18 years, regardless of sex; 2. American Society of Anesthesiologists (ASA) physical status I–III; 3. Scheduled for elective surgery under general anesthesia; 4. Identified as high risk for postoperative nausea and vomiting (PONV) according to the established multivariable prediction model; 5. Expected postoperative hospital stay of at least 48 hours; 6. Ability to understand the study procedures and provide written informed consent.

Exclusion criteria

Exclusion criteria: Part 1: 1. History of or current severe neurological disorders, such as stroke or epilepsy; 2. Psychiatric disorders or cognitive impairment that prevent cooperation with study procedures; 3. Severe hepatic or renal dysfunction, or significant cardiopulmonary dysfunction; 4. Pregnant or breastfeeding women; 5. Previous treatment with auricular vagus nerve stimulation; 6. Known allergy to any drugs or devices involved in this study; 7. Postoperative admission to the intensive care unit (ICU). Part 2: 1. History of or current middle or external ear diseases, ear skin lesions or dermatological conditions, or known allergy to electrode materials; 2. Presence of an implanted cardiac pacemaker or other active implantable electronic devices; 3. Psychiatric disorders or cognitive impairment preventing cooperation with study procedures or completion of subjective assessments; 4. Pregnant or breastfeeding women; 5. Intraoperative changes in anesthesia technique, surgical interruption, or postoperative admission to the intensive care unit (ICU); 6. Refusal to receive the intervention or withdrawal from the study during the trial period.

Design outcomes

Primary

Measure	Time frame
Use of rescue antiemetic medication;Number of vomiting episodes;Incidence of postoperative nausea and vomiting (PONV);Severity of nausea (VAS score);	—

Secondary

Measure	Time frame
Total postoperative analgesic consumption (MME);Sleep quality score (PSQI);Patient satisfaction;Intervention adherence and withdrawal;Gastrointestinal function recovery time;Ear-related adverse events;	—

Countries

China

Contacts

Public ContactBin Zhang

the Second Hospital of Jiaxing

zhangbin@jxey.com+86 573 8204 2341

Outcome results

None listed

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