Effects of taVNS Combined With Dexmedetomidine on POVN

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Postoperative Nausea and Vomiting

Treatments: Device: Transcutaneous Auricular Vagus Nerve Stimulator; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07271147

2025-K265-02

Details and patient eligibility

About

To explore the effects and possible mechanisms of dexmedetomidine combined with taVNS on the incidence of postoperative nausea and vomiting in female patients undergoing laparoscopic surgery

Full description

Patients are recruited one week prior to the start of the trial, during which they are informed about the experimental protocol and associated risks. After obtaining informed consent and signatures, they are enrolled as study participants. Patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham taVNS group) and the intervention group (taVNS group, with taVNS intervention starting 30 minutes prior to anesthesia induction and continuing until the end of surgery, terminating after the removal of the endotracheal tube in the PACU), in a double-blind manner (with taVNS intervention and postoperative follow-up conducted by different researchers).

Enrollment: 176 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups

Dexmedetomidine combined with taVNS(taVNS group)

Experimental group

Description:

Patients in the taVNS group will have a transcutaneous auricular vagus nerve stimulation device with a transparent, non-insulated thin film placed on the cymba conchae of the left ear. TaVNS will be administered on the day of surgery (starting 30 minutes before anesthesia induction and continuing until the end of the surgery, terminating after the removal of the endotracheal tube in the PACU). The stimulation parameters are set as follows: frequency 25 Hz, pulse width 200 μs, 30 seconds on / 30 seconds off, with the current intensity set to the maximum amplitude the patient can tolerate (just below the pain threshold). Dexmedetomidine was administered intravenously by infusion pump (0.5 μg/kg over 10 minutes, followed by continuous infusion at 0.4 μg/kg/h) in combination with taVNS (initiated 30 minutes before anesthesia induction and terminated after tracheal tube removal in the PACU upon the conclusion of the surgery).

Treatment:

Drug: Dexmedetomidine

Device: Transcutaneous Auricular Vagus Nerve Stimulator

Dexmedetomidine combined with sham transcutaneous auricular vagus nerve stimulation

Sham Comparator group

Description:

Patients in the Sham taVNS group will have a transcutaneous auricular vagus nerve stimulation device with a transparent insulating film placed on the cymba conchae of the left ear on the day of surgery. The stimulation parameters, method, and duration will be the same as those in the taVNS group. However, due to the insulating film applied to the stimulation device in the sham group, patients will not actually receive any stimulation. Dexmedetomidine was administered intravenously by infusion pump (0.5 μg/kg over 10 minutes, followed by continuous infusion at 0.4 μg/kg/h) in combination with taVNS (initiated 30 minutes before anesthesia induction and terminated after tracheal tube removal in the PACU upon the conclusion of the surgery).

Treatment:

Drug: Dexmedetomidine