Effects of taVNS Combined With Dexmedetomidine on POVN

NCT ID: NCT07271147

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-07
• Study Completion Date: 2026-12-01

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

Detailed Description

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).

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine combined with taVNS(taVNS group)

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).

Group Type: EXPERIMENTAL

Transcutaneous Auricular Vagus Nerve Stimulator

Intervention Type: 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

Intervention Type: 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

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).

Group Type: SHAM_COMPARATOR

Dexmedetomidine

Intervention Type: 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).

Interventions

Transcutaneous Auricular Vagus Nerve Stimulator

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).

Intervention Type: DEVICE

Dexmedetomidine

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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Chaochao Zhong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chao-Chao Zhong

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Nantong University

Locations

Affiliated hospital of Nantong University

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

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

Role: CONTACT

zhong249767626@163.com

15152460489

Facility Contacts

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

Role: primary

zhong249767626@163.com

15152460489

Other Identifiers

2025-K265-02

Identifier Type: -

Identifier Source: org_study_id