Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS)on the Incidence Rate of Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Radical Surgery for Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Incidence rate of SIRS
研究概览
简要总结
The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in patients undergoing radical surgery for gastric cancer
详细描述
Patients undergoing elective radical surgery for gastric cancer under general anesthesia were randomly assigned to three groups, control group , TEAS group and sham TEAS group.
TEAS group receiving TEAS before general anesthesia induction , 1th day and 2nd day after surgery. TEAS was given through electrodes attached to specific acupoints. The time for TEAS was 30min.
Sham TEAS group receiving sham TEAS before general anesthesia induction , 1th day and 2nd day after surgery. Sham TEAS was given through electrodes attached to non-acupoints. The time for sham TEAS was also 30min.
Control group were given no TEAS. Incidence rates of SIRS in each group were compared .Venous blood samples from all groups(control group , TEAS group and sham TEAS group) were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,Tumor Necrosis Factor- alpha(TNF-α),Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>30yrs,<75yrs
- •Scheduled for radical surgery for gastric cancer under general anesthesia；
- •Informed consented
排除标准
- •Patients with implanted pacemakers
- •Patients with severe hypertension or cardiac dysfunction；
- •Patients with severe pulmonary disease
- •Patients with hemoglobin<90g/L
结局指标
主要结局
Incidence rate of SIRS
时间窗: 1st day after surgery
SIRS is defined as 2 or more of the following variables : 1. Fever of more than 38°C (100.4°F) or less than 36°C (96.8°F) 2. Heart rate of more than 90 beats per minute 3. Respiratory rate of more than 20 breaths per minute or arterial carbon dioxide tension (PaCO2) of less than 32mm Hg 4. Abnormal white blood cell count (\>12,000/µL or \< 4,000/µL or \>10% immature granulocyte forms) Incidence rate of SIRS is calculated using the following formula: (Number of SIRS Cases within the group) / (Number of Cases within the group)
次要结局
- Change of Inflammatory cytokines(30 minutes before general anesthesia induction and 1st and 3rd day after the surgery)
- Incidence rate of SIRS(3rd day after surgery)
研究者
QiangWang,MD
associate professor,PhD advisor
Air Force Military Medical University, China