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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: zhong249767626@163.com
• Phone: 15152460489

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.