taVNS plus dexmedetomidine to reduce postoperative nausea and vomiting after laparoscopic surgery

The Effect of Dexmedetomidine Combined With Percutaneous Auricular Vagus Nerve Stimulation on Postoperative Nausea and Vomiting in Female Laparoscopic Patients: A Randomized Controlled Trial

We will see if adding noninvasive ear (taVNS) stimulation to the sedative dexmedetomidine reduces postoperative nausea and vomiting in women having elective laparoscopic surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Affiliated Hospital of Nantong University (Academic / other)
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT07271147 on ClinicalTrials.gov

What this trial studies

Women aged 18–65 scheduled for elective laparoscopic surgery are recruited a week before surgery, consented, and randomized 1:1 to receive either real transcutaneous auricular vagus nerve stimulation (taVNS) or a sham procedure in addition to dexmedetomidine. The taVNS intervention starts 30 minutes before anesthesia induction and continues until the end of surgery, stopping after extubation in the PACU, with the intervention and postoperative follow-up performed by different blinded researchers. The trial collects postoperative nausea and vomiting incidence and related clinical measures and will explore physiological markers to suggest possible mechanisms for any observed effect. Randomization is double-blind to participants and the researchers who perform follow-up assessments.

Who should consider this trial

Good fit: Adult women (18–65 years) with ASA physical status I–II who are scheduled for elective laparoscopic surgery under general anesthesia and can provide informed consent are the ideal candidates.

Not a fit: Patients with ASA ≥ III, significant cardiovascular or liver/kidney dysfunction, obesity (BMI >30), pregnancy or breastfeeding, implanted stimulators, recent use of antiemetics/opioids/psychoactive drugs, or other listed exclusions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could lower the rate and severity of postoperative nausea and vomiting, improving patient comfort and reducing the need for rescue antiemetics.

How similar studies have performed: Dexmedetomidine has shown some benefit for reducing PONV in prior trials and taVNS has limited early evidence for antiemetic effects, but combining taVNS with dexmedetomidine is a relatively novel approach.

Eligibility criteria

Inclusion Criteria:

* Women aged 18 to 65;
* Elective laparoscopic surgery under general anesthesia;
* Classified as American Society of Anesthesiologists (ASA) physical status I to II;
* Capable of understanding the study procedures and various assessment scales and able to effectively communicate with the researchers;
* Willing to participate in the study and provide written informed consent.

Exclusion Criteria:

* Patients with ASA anesthesia classification ≥ III;
* Poorly controlled hypertension, atrioventricular block ≥ second degree, obesity (BMI \> 30 kg/m²);
* Pregnant or breastfeeding;
* Known allergy to drugs used in the study protocol, history of traumatic brain injury, history of gastrointestinal surgery;
* Liver or kidney dysfunction (liver enzymes or creatinine ≥ 1.5 times the normal value), alcoholism or drug abuse, mental illness, use of antiemetics, opioids, psychoactive drugs, or corticosteroids within 24 hours before surgery;
* Patients with implanted stimulators (such as pacemakers, implantable vagus nerve stimulators, deep brain stimulators, spinal cord stimulators, etc.), cochlear implants, or metal implants (except in dental cases);
* Skin lesions or dermatological diseases at the site of electrical stimulation;
* Preoperative heart rate \< 50 bpm or the presence of sinoatrial node disease or second-degree or higher atrioventricular block;
* Patients unable to cooperate with assessments;
* Patients participating in other clinical trials.

Where this trial is running

Nantong, Jiangsu

• Affiliated hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Chao-Chao Zhong — Affiliated Hospital of Nantong University
• Study coordinator: Chao-Chao Zhong, M.D.;P.h.D

Conditions Postoperative Nausea and Vomiting