Yin Weijuan, Fang Fang, Zhang Yan, Xi Lijuan
Department of Gastrointestinal Surgery, The Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.
The Nursing Department, Northern Jiangsu People's Hospital, Yangzhou, China.
Front Med (Lausanne). 2025 Mar 5;12:1497647. doi: 10.3389/fmed.2025.1497647. eCollection 2025.
To develop a study protocol for determining the optimal timing of Transcutaneous Electrical Acupoint Stimulation (TEAS) to enhance postoperative recovery in elderly patients. The study aims to evaluate different timing strategies for TEAS administration and their effects on postoperative outcomes, with the goal of improving clinical practices and guiding future research.
A total of 266 geriatric patients who underwent radical resection of gastrointestinal tumors will be divided into seven groups: one control group (receiving standardized perioperative management), one sham intervention group (receiving TEAS treatment without electrical stimulation), and five intervention groups (receiving TEAS at different time intervals). The intervention groups will receive TEAS at bilateral Neiguan (PC6) and Zusanli (ST36) acupoints. The TEAS treatment will employ an altered frequency of 2/100 Hz with disperse-dense waveforms and an adjustable intensity, ensuring the stimulation remains below 10 mA and within a tolerable range for the patient. The device will output an asymmetrical biphasic pulse wave, with a pulse width of 0.2 ms ± 30%, based on electromagnetic compatibility basic performance testing. The primary outcome will assess changes in cognition, measured using neuropsychological tests administered preoperatively and 3 days postoperatively, as well as the Telephone Interview for Cognitive Status-Modified (TICS-m) at 1, 3, and 6 months postoperatively. Secondary outcomes will include preoperative and 3-day postoperative measurements of interleukin-6 (IL-6), S100 calcium-binding protein β (S100β), tumor necrosis factor alpha (TNF-), insulin-like growth factor 1 (IGF-1), and C-reactive protein (CRP). Additional data will be collected on the time to postoperative exhaust, defecation, eating, and the first postoperative ambulation. Numeric Rating Scale (NRS) scores will be recorded before and on the third day after the operation, alongside Activities of Daily Living (ADL) and Braden scale scores, which will be assessed before the operation and at the time of discharge.
This protocol aims to determine the optimal timing of TEAS for improving postoperative recovery in geriatric patients with gastrointestinal tumor.
ClinicalTrials.gov, identifier NCT05482477.
制定一项研究方案，以确定经皮穴位电刺激（TEAS）的最佳时机，以促进老年患者术后恢复。该研究旨在评估TEAS给药的不同时间策略及其对术后结局的影响，目标是改进临床实践并指导未来研究。
总共266例接受胃肠道肿瘤根治性切除术的老年患者将被分为七组：一组对照组（接受标准化围手术期管理），一组假干预组（接受无电刺激的TEAS治疗），以及五组干预组（在不同时间间隔接受TEAS）。干预组将在双侧内关（PC6）和足三里（ST36）穴位接受TEAS。TEAS治疗将采用2/100 Hz的变频，疏密波，强度可调，确保刺激强度保持在10 mA以下且在患者可耐受范围内。根据电磁兼容性基本性能测试，该设备将输出不对称双相脉冲波，脉宽为0.2 ms±30%。主要结局将评估认知变化，通过术前和术后3天进行的神经心理学测试以及术后1、3和6个月的改良认知状态电话访谈（TICS-m）来衡量。次要结局将包括术前和术后3天测量白细胞介素-6（IL-6）、S100钙结合蛋白β（S100β）、肿瘤坏死因子α（TNF-）、胰岛素样生长因子1（IGF-1）和C反应蛋白（CRP）。还将收集术后排气、排便、进食时间以及术后首次下床活动时间的额外数据。将在手术前和手术后第三天记录数字评分量表（NRS）分数，以及在手术前和出院时评估日常生活活动（ADL）和Braden量表分数。
本方案旨在确定TEAS改善老年胃肠道肿瘤患者术后恢复的最佳时机。
ClinicalTrials.gov，标识符NCT05482477。
