Effects of taVNS Combined With Dexmedetomidine on POVN

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAffiliated Hospital of Nantong University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous Auricular Vagus Nerve Stimulator

    Device

    Intervention Timing of Transcutaneous Auricular Vagus Nerve Stimulator: The intervention will begin 30 minutes before anesthesia induction and continue 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

    Drug

    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 groups

176 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine combined with taVNS(taVNS group)Experimental treatment 2 interventions
Group B: Dexmedetomidine combined with sham transcutaneous auricular vagus nerve stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Postoperative PONV

Patients who experience at least one episode of nausea, vomiting, or retching, or any combination of these, within the first 24 hours after surgery are considered to have PONV.

Time frame
The first 24 hours postoperatively

Secondary outcomes

1

The frequency of nausea, retching and vomiting within 2 hours, 6 hours, 24 hours and 48 hours after surgery.

Postoperative nausea is defined as the occurrence of nausea at least once without retching or vomiting. Retching is defined as the patient experiencing regular spasms in the chest and abdominal muscles without the expulsion of gastric contents. Vomiting is defined as vomiting or retching at least once.

Time frame
From 2 hours postoperatively to 48 hours postoperatively
2

Frequency of remedial antiemetic administration within 2 hours, 6 hours, 24 hours and 48 hours after surgery.

Time frame
From 2 hours postoperatively to 48 hours postoperatively
3

The severity of nausea and vomiting within 2 hours, 6 hours, 24 hours and 48 hours after surgery.

Severity was assessed using a 4-point Likert scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.

Time frame
From 2 hours postoperatively to 48 hours postoperatively
4

Incidence of PONV at 2 hours, 6 hours, and 48 hours postoperatively

Patients who experienced at least one episode of nausea, vomiting, retching, or any combination thereof within the first 2, 6, or 48 hours after surgery were considered to have PONV.

Time frame
From 2 hours postoperatively to 48 hours postoperatively

Other outcomes

Sponsors and contacts

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