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Effect of Transcutaneous Vagus Nerve Stimulation on Postoperative Nausea and Vomiting in Patients Undergoing Gynecological Laparoscopic Surgery

Effect of Transcutaneous Vagus Nerve Stimulation on Postoperative Nausea and Vomiting in Patients Undergoing Gynecological Laparoscopic Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117517
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-01-28
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Postoperation Nausea and Vomiting

Interventions

The Real stimulation group (The intervention group):Using the gammacore (ElectroCore, LLC) instrument, a single 120-second vagus nerve stimulation was performed on the cervical branch of the internal
The sham stimulation group (The control group):Using the same instrument, after placing it in the correct position, start the stimulation. Use a stimulus intensity of less than 3 to stimulate the righ

Sponsors

Beijing Shijitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for gynecological laparoscopic surgery under general anesthesia; 2. Age 18-65; 3. American Society of Anesthesiologists (ASA) class I–III; 4. High risk for postoperative nausea and vomiting, score 3-4; 5. Voluntarily participate in the study and sign the informed consent form. Exclusion criteria.

Exclusion criteria

Exclusion criteria: 1. Presence of nVNS contraindications (having implanted medical devices or metal devices in or near the neck) or injury at the stimulation site; 2. Preoperative sinus bradycardia (100 bpm); 3. Long-term use of long-acting antiemetics, emetics, opioids, or glucocorticoids; 4. Pregnancy or breastfeeding; 5. Presence of other conditions that may cause nausea or vomiting, such as hepatitis or gastric ulcers, or occurrence within the past week; 6. Patients whose nausea and vomiting symptoms have not resolved; 7. History of prior vagus nerve surgery; 8. Uncontrolled hypertension or hypotension; 9. Severe cardiovascular, hepatic, or renal disease, or mental or neurological disorders preventing participation in the study; 10. Hearing or speech impairments; 11. Refusal to cooperate with the experiment; 12. Preoperative gastric emptying disorders (persistent postprandial fullness and nausea due to poor long-term blood sugar control; sleeve gastrectomy; multiple sclerosis; scleroderma; taking medications such as semaglutide that delay gastric emptying).

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative nausea and vomiting within 24 hours in both groups;

Secondary

MeasureTime frame
The incidence rates of postoperative nausea and postoperative vomiting (dry vomiting) within 0-6 hours and 6-24 hours after the operation;The number of patients who experienced varying degrees of postoperative nausea, postoperative vomiting, and postoperative retching within 24 hours after the operation;The number of patients requiring emergency antiemetic drugs within 24 hours after surgery and the amount of rescue medication used;The number of patients requiring emergency analgesics within 24 hours after surgery and the details of their medication usage;Postoperative 24-hour Numerical Rating Scale (NRS) pain score;The time of the first postoperative expulsion of gas and defecation for the two groups;The heart rate variability indicators before and after the first stimulation and the heart rate variability indicators before and after the second stimulation;The levels of serum IL-6, IL-1ß, TNF-a and IL-10 in the venous blood collected in the morning before the operation and on the first day after the operation;The Bang blindness index (BBI) of the two groups;

Countries

China

Contacts

Public ContactMiao Huihui

Beijing Shijitan Hospital, Capital Medical University

iverymhh@hotmail.com+86 158 0121 3581

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026