Effects of taVNS Combined With Dexmedetomidine on POVN

NCT07271147 | Recruiting

• 1 other identifier: 2025-K265-02
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

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.

  The first 24 hours postoperatively

Secondary Outcomes (11)

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

  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.

  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.

  From 2 hours postoperatively to 48 hours postoperatively

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

  From 2 hours postoperatively to 48 hours postoperatively

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

  From 2 hours postoperatively to 48 hours postoperatively

Study Arms (2)

Dexmedetomidine combined with taVNS(taVNS group)

EXPERIMENTAL

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

Dexmedetomidine combined with sham transcutaneous auricular vagus nerve stimulation

SHAM COMPARATOR

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

Interventions

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 combined with taVNS(taVNS group)

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).

Dexmedetomidine combined with sham transcutaneous auricular vagus nerve stimulation; Dexmedetomidine combined with taVNS(taVNS group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chao-Chao Zhong

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

15152460489; zhong249767626@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 9, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)