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NCT Number: NCT07271147

Effects of taVNS Combined With Dexmedetomidine on POVN

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location status: Recruiting

Location contact

Chao-Chao Zhong, M.D.;P.H.D

CONTACT

[email protected]

15152460489

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Incidence of Postoperative PONV

    Time frame: The first 24 hours postoperatively

    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

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

    Time frame: From 2 hours postoperatively to 48 hours postoperatively

    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.

  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.

    Time frame: From 2 hours postoperatively to 48 hours postoperatively

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

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

    Time frame: From 2 hours postoperatively to 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.

  5. Postoperative NRS pain scores at 2 h, 6 h, 24 h, and 48 h

    Time frame: From 2 hours postoperatively to 48 hours postoperatively

    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.

  6. 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

  7. 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

  8. Intraoperative incidence of hypotension and bradycardia

    Time frame: during surgery

    Hypotension was defined as a mean arterial pressure < 60 mmHg, and bradycardia as a heart rate < 50 bpm.

  9. Incidence of other adverse reactions within 48 h after surgery (dizziness, somnolence, dry mouth, skin irritation).

    Time frame: The first 48 hours postoperatively

  10. Preoperative and 24-hour postoperative Hospital Anxiety and Depression Scale (HADS)

    Time frame: From 1 day preoperatively to 24 hours postoperatively

    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.

  11. PROMIS SD-SF 8a Assessment on Preoperative and 24-hour Postoperative

    Time frame: From 1 day preoperatively to 24 hours postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao-Chao Zhong, M.D.;P.h.D

CONTACT

[email protected]

15152460489

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

The Effect of Dexmedetomidine Combined With Percutaneous Auricular Vagus Nerve Stimulation on Postoperative Nausea and Vomiting in Female Laparoscopic Patients: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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