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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Transcutaneous Auricular Vagus Nerve Stimulator
DeviceIntervention 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
DrugDexmedetomidine 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Frequency of remedial antiemetic administration within 2 hours, 6 hours, 24 hours and 48 hours after surgery.
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.
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.
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