Effects of taVNS Combined With Dexmedetomidine on POVN

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

• Устройство 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).
• Препарат 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).

Первичные конечные точки

• Incidence of Postoperative PONV [Срок оценки: The first 24 hours postoperatively]

Вторичные конечные точки (11)

• The frequency of nausea, retching and vomiting within 2 hours, 6 hours, 24 hours and 48 hours after surgery. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: From 2 hours postoperatively to 48 hours postoperatively]
• Incidence of PONV at 2 hours, 6 hours, and 48 hours postoperatively [Срок оценки: From 2 hours postoperatively to 48 hours postoperatively]
• Postoperative NRS pain scores at 2 h, 6 h, 24 h, and 48 h [Срок оценки: 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 [Срок оценки: From 2 hours postoperatively to 48 hours postoperatively]
• Frequency of rescue analgesic use at 2 h, 6 h, 24 h, and 48 h postoperatively [Срок оценки: From 2 hours postoperatively to 48 hours postoperatively]
• Intraoperative incidence of hypotension and bradycardia [Срок оценки: during surgery]
• Incidence of other adverse reactions within 48 h after surgery (dizziness, somnolence, dry mouth, skin irritation). [Срок оценки: The first 48 hours postoperatively]
• Preoperative and 24-hour postoperative Hospital Anxiety and Depression Scale (HADS) [Срок оценки: From 1 day preoperatively to 24 hours postoperatively]
• PROMIS SD-SF 8a Assessment on Preoperative and 24-hour Postoperative [Срок оценки: From 1 day preoperatively to 24 hours postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Affiliated hospital of Nantong University — Nantong

Идентификаторы

NCT: NCT07271147 · 2025-K265-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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