NCT07338448尚未招募不适用
The Effect of Electrical Acupoint Stimulation on Gastric Reflux During Anesthesia With I-gel Ventilation
Air Force Military Medical University, China0 个研究点目标入组 116 人开始时间: 2026年1月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 主要终点
- pH value at middle-esophageal part at end of surgery
研究概览
简要总结
This study will compare the effects of transcutaneous acupoint electrical stimulation versus no stimulation on intraoperative gastric reflux in patients undergoing general anesthesia with i-gel airway device ventilation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years old
- •scheduled for surgery under general anesthesia with igel ventilation
排除标准
- •American society of anesthesiologists status higher than grade 3
- •history of gastrointestinal surgery
- •Currently taking acidic medications, or medications that affect gastric acid secretion or gastrointestinal motility
- •High risk of reflux or aspiration (e.g., symptomatic gastroesophageal reflux disease or hiatal hernia)
- •History of postoperative nausea and vomiting (PONV)
- •Intraoperative requirement of Trendelenburg position
- •Expected surgery duration exceeding 4 hours
- •Contraindications for acupoint electrical stimulation, such as patients with implanted electrophysiological devices, or skin infection/lesions at acupoint sites
结局指标
主要结局
pH value at middle-esophageal part at end of surgery
时间窗: at end of surgery
次要结局
- number of gastric reflux episodes(from intubation of igel to end of surgery, at an average of 2 hours)
- total duration of gastric reflux episodes(from intubation of igel to end of surgery, at an average of 2 hours)
- longest duration of gastric reflux episodes(from intubation of igel to end of surgery, at an average of 2 hours)
- pH value at glottis at the end of surgery(at end of surgery)
- percentage of patients suffering postoperative nausea and vomiting by 24 hours after surgery(from end of surgery to 24 hours after surgery)
研究者
Zhihong LU
Professor
Air Force Military Medical University, China
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