Peking Union Medical College, Beijing, China.
Department of Anaesthesiology, Peking Union Medical College Hospital, Beijing, China.
BMJ Open. 2024 Sep 23;14(9):e088633. doi: 10.1136/bmjopen-2024-088633.
This study evaluates the efficacy of integrating percutaneous electrical nerve stimulation at the pericardium 6 (PC6) acupuncture point through a wearable acustimulation device with standard pharmacological prophylaxis to prevent postoperative nausea and vomiting (PONV) compared with pharmacological prophylaxis alone in patients undergoing laparoscopic abdominal surgery.
This prospective study will enrol 302 patients scheduled for elective laparoscopic surgery. Participants will be randomly allocated to one of two groups: acustimulation combined with pharmacological prophylaxis or sham stimulation combined with pharmacological prophylaxis. Randomisation will involve a computer-generated sequence, with allocation concealment implemented through sealed envelopes. The acustimulation group will receive electrical stimulation at the PC6 point starting 30 min before surgery and continuing until discharge from the postanaesthesia care unit. Sham group will wear a wristband that does not provide stimulation. The primary outcome is the incidence of PONV. Secondary outcomes include the severity of PONV, incidence rates of nausea and vomiting at different postoperative intervals and indices of gastrointestinal functional recovery. Exploratory outcomes will assess haemodynamic parameters, baroreflex sensitivity, hospital stay duration, costs and both short-term and long-term postoperative recovery.
All participants will provide written informed consent. The study has been approved by the Ethics Committee of Peking Union Medical Hospital (approval number: I-23PJ1712). Results will be published open access.
NCT06241547.
本研究通过可穿戴式声电刺激设备将经皮电神经刺激心包 6 穴(PC6)与标准药物预防疗法相结合,评估其与单独药物预防疗法相比,预防腹腔镜腹部手术后恶心和呕吐(PONV)的疗效。
本前瞻性研究将纳入 302 例择期行腹腔镜手术的患者。参与者将被随机分配到以下两组中的一组:声电刺激联合药物预防组或假刺激联合药物预防组。随机分组将通过计算机生成的序列进行,采用密封信封实现分配隐藏。声电刺激组将在手术前 30 分钟开始接受 PC6 点的电刺激,并持续到离开麻醉后护理病房。假刺激组将佩戴一个不提供刺激的腕带。主要结局是 PONV 的发生率。次要结局包括 PONV 的严重程度、不同术后时间点恶心和呕吐的发生率以及胃肠道功能恢复的指标。探索性结局将评估血流动力学参数、压力反射敏感性、住院时间、成本以及短期和长期术后恢复。
所有参与者将提供书面知情同意书。该研究已获得北京协和医院伦理委员会的批准(编号:I-23PJ1712)。研究结果将公开获取。
NCT06241547。