The Effect of Dexmedetomidine Combined With Percutaneous Auricular Vagus Nerve Stimulation on Postoperative Nausea and Vomiting in Female Laparoscopic Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative PONV
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Transcutaneous Auricular Vagus Nerve Stimulator (Device)
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).
干预措施: Dexmedetomidine (Drug)
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).
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Incidence of Postoperative PONV
时间窗: 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.
次要结局
- 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)
- Number of patient-controlled analgesia (PCA) pump activations at 2 h, 6 h, 24 h, and 48 h after surgery(From 2 hours postoperatively to 48 hours postoperatively)
- Frequency of rescue analgesic use at 2 h, 6 h, 24 h, and 48 h postoperatively(From 2 hours postoperatively to 48 hours postoperatively)
- Intraoperative incidence of hypotension and bradycardia(during surgery)
- Incidence of other adverse reactions within 48 h after surgery (dizziness, somnolence, dry mouth, skin irritation).(The first 48 hours postoperatively)
- Preoperative and 24-hour postoperative Hospital Anxiety and Depression Scale (HADS)(From 1 day preoperatively to 24 hours postoperatively)
- PROMIS SD-SF 8a Assessment on Preoperative and 24-hour Postoperative(From 1 day preoperatively to 24 hours postoperatively)
研究者
Chaochao Zhong
Principal Investigator
Affiliated Hospital of Nantong University