An interventional study of Transcutaneous Auricular Vagus Nerve Stimulator and Dexmedetomidine in Postoperative Nausea and Vomiting, sponsored by Affiliated Hospital of Nantong University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Affiliated Hospital of Nantong University · Not applicable, Interventional, and Prevention
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
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).
Exclusion Criteria:
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).
Device: Transcutaneous Auricular Vagus Nerve Stimulator · Drug: Dexmedetomidine
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).
Drug: Dexmedetomidine
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 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).
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
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
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
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
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
Postoperative NRS pain scores at 2 h, 6 h, 24 h, and 48 h
The NRS (Numerical Rating Scale) is used to assess the intensity of pain.Minimum: 0 Maximum: 10.The higher the score, the more severe the pain.
Time frame: From 2 hours postoperatively to 48 hours postoperatively
Number of patient-controlled analgesia (PCA) pump activations at 2 h, 6 h, 24 h, and 48 h after surgery
Time frame: From 2 hours postoperatively to 48 hours postoperatively
Frequency of rescue analgesic use at 2 h, 6 h, 24 h, and 48 h postoperatively
Time frame: From 2 hours postoperatively to 48 hours postoperatively
Intraoperative incidence of hypotension and bradycardia
Hypotension was defined as a mean arterial pressure \< 60 mmHg, and bradycardia as a heart rate \< 50 bpm.
Time frame: during surgery
Incidence of other adverse reactions within 48 h after surgery (dizziness, somnolence, dry mouth, skin irritation).
Time frame: The first 48 hours postoperatively
Preoperative and 24-hour postoperative Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is used to assess the severity of anxiety and depression in individuals. Full scale title: Hospital Anxiety and Depression Scale (HADS) - Full 14-Item Version Minimum score: 0 Maximum score: 42 (0-21 for the anxiety subscale and 0-21 for the depression subscale) Interpretation: Higher scores indicate greater severity of anxiety and/or depression, representing worse outcomes.
Time frame: From 1 day preoperatively to 24 hours postoperatively
PROMIS SD-SF 8a Assessment on Preoperative and 24-hour Postoperative
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8a (PROMIS SD-SF 8a) is an 8-item self-reported questionnaire developed by the Patient-Reported Outcomes Measurement Information System to assess sleep disturbance over the past 7 days. It evaluates aspects such as difficulty falling asleep, sleep maintenance, sleep quality, and daytime functioning, providing a standardized measure of sleep disturbance severity. Full scale title Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8a (PROMIS SD-SF 8a) - 8-Item Version Score range Minimum: 8 Maximum: 40 Interpretation Higher scores indicate greater sleep disturbance over the past seven days, corresponding to worse outcomes.
Time frame: From 1 day preoperatively to 24 hours postoperatively
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Postoperative Nausea and Vomiting→
Affiliated Hospital of Nantong University