Gao Wei, Zhang Linzhong, Han Xuechang, Wei Lai, Fang Jie, Zhang Xiaqing, Zhang Jiaqiang, Wang Haiyun, Zhou Qi, Wang Chenggang, Chen Wenting, Ni Xinli, Yang Lan, Du Ruini, Wang Ge, Liu Bingyu, Li Yajuan, Zhang Shanshan, Wang Qiang
Department of Anesthesiology, Center for Brain Science, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Department of Anesthesiology, Second Hospital of Shanxi Medical University, Taiyuan, China.
Front Med (Lausanne). 2022 Mar 14;9:766244. doi: 10.3389/fmed.2022.766244. eCollection 2022.
Postoperative nausea and vomiting (PONV) gives patients a bad experience and negates their good recovery from surgery.
This trial aims to assess the preventive effectiveness of transcutaneous electrical acupoint stimulation (TEAS) on the incidence of PONV in high-risk surgical patients.
The large sample size, multicenter, evaluator-blinded, and randomized controlled study was conducted between September 3, 2019 to February 6, 2021.
The 12 hospitals were from different Chinese provinces.
After obtaining ethics approval and written informed consent, 1,655 patients with Apfel score ≥ 3 points were enrolled for selective laparoscopic non-gastrointestinal surgery under general anesthesia.
Patients were randomly allocated into the TEAS and Sham group with a 1:1 ratio. The TEAS group was stimulated on bilateral Neiguan and Zusanli acupoints after recovery from anesthesia on the surgical day and the next morning for 30 min, while the Sham group received an identical setting as TEAS but without currents delivered. Electronic patient self-reported scale was used to evaluate and record the occurrence of PONV.
Primary clinical end point is the incidence of PONV which was defined as at least one incidence of nausea, retching, or vomiting after operation within postoperative 24 h.
Compared with the Sham treatment, the TEAS lowered the PONV incidence by 4.8% (29.4 vs. 34.2%, = 0.036) and vomiting incidence by 7.4% (10.4 vs. 17.8%, < 0.001). TEAS also lowered persistent nausea incidence and PONV scores and decreased PONV related complications and Quality of Recovery-40 scores ( < 0.05). TEAS lowered the 24 h PONV risk by 20% (OR, 0.80, 95% CI, 0.65 -0.98; = 0.032), and lowered hazard ratio by 17% (HR, 0.83, 95% CI, 0.70-0.99; = 0.035). Both TEAS and palonosetron were the independent PONV risk protective factors for 24 h PONV incidence and cumulative PONV incidence. The combination of TEAS and palonosetron was the most effective strategy to reduce the PONV incidence ( < 0.001).
TEAS attenuated the PONV incidence and severity in high-risk surgical patients and may be applied clinically as a complement therapy to prevent PONV.
https://clinicaltrials.gov/ct2/show/NCT04043247, identifier: NCT04043247.
术后恶心呕吐（PONV）会给患者带来不良体验，影响其术后的良好恢复。
本试验旨在评估经皮穴位电刺激（TEAS）对高危手术患者PONV发生率的预防效果。
本研究为大样本量、多中心、评估者盲法、随机对照试验，于2019年9月3日至2021年2月6日进行。
12家医院来自中国不同省份。
在获得伦理批准和书面知情同意后，1655例Apfel评分≥3分的患者纳入全身麻醉下的选择性腹腔镜非胃肠道手术。
患者按1:1比例随机分为TEAS组和假刺激组。TEAS组在手术日麻醉苏醒后及次日早晨对双侧内关穴和足三里穴进行刺激，每次30分钟，而假刺激组接受与TEAS组相同的设置，但不施加电流。采用电子患者自我报告量表评估并记录PONV的发生情况。
主要临床终点为PONV发生率，定义为术后24小时内至少发生一次恶心、干呕或呕吐。
与假刺激治疗相比，TEAS使PONV发生率降低了4.8%（29.4%对34.2%，P = 0.036），呕吐发生率降低了7.4%（10.4%对17.8%，P < 0.001）。TEAS还降低了持续性恶心发生率和PONV评分，减少了PONV相关并发症及恢复质量-40评分（P < 0.05）。TEAS使24小时PONV风险降低了20%（OR，0.80，95%CI，0.65 - 0.98；P = 0.032），风险比降低了17%（HR，0.83，95%CI，0.70 - 0.99；P = 0.035）。TEAS和帕洛诺司琼均为24小时PONV发生率和累积PONV发生率的独立PONV风险保护因素。TEAS与帕洛诺司琼联合使用是降低PONV发生率最有效的策略（P < 0.001）。
TEAS可降低高危手术患者的PONV发生率和严重程度，可作为预防PONV的临床补充治疗方法应用。
https://clinicaltrials.gov/ct2/show/NCT04043247，标识符：NCT04043247。
