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临床试验/NCT02951611
NCT02951611Unknown不适用

Effects of Acupuncture Stimulation on Systemic Inflammation in Patients Undergoing Video-assisted Thoracoscopic Lobectomy Surgery

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
serum TNF-α level

研究概览

简要总结

60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30 patients in each group: 1. control group and 2. treatment group. Patients in treatment group will receive transcutaneous electrical acupoint stimulation(TEAS) during the surgery and at 6h and 24h after surgery. Patients in the control group received only TIVA general anesthesia and sham electrical stimulation. Serum from patients of both groups will be collected at before surgery, 1h and 25h after surgery, respectively. Serum levels of TNF-alpha, IL-1 beta, CXCL8, IFN gamma and IL-4 at different time points will be measured and compared between the two groups.

详细描述

60 ASA physical status I or II patients, aged 18-75 years old , scheduled for elective video-assisted thoracoscopic lobectomy surgery,will be randomized into 2 groups,with 30 patients in each group: 1. control group, who will receive total intravenous anesthesia(TIVA) and sham stimulation; and 2. treatment group, who will receive (TIVA) and transcutaneous electrical acupoint stimulation(TEAS). Since 30 min before induction of anesthesia, patients in treatment group will be stimulated at the 4 acupoints , Houxi、Zhigou、Neiguan and Hegu on both sides by Han's Acupoint Nerve Stimulator(HANS) until the end of the operation. At 6h and 24h after surgery, patients in treatment group will receive TEAS again, for 30 min each time.The frequency was 2/100Hz,the stimulate intensity was the maximum current that could be tolerated when the patients were awake.The control group received only TIVA general anesthesia and sham electrical stimulation.Serum from patients of both groups will be collected at before surgery, 1h and 25h after surgery, respectively and serum levels of TNF-alpha, IL-1 beta, CXCL8, IFN gamma and IL-4 at different time points will be measured. The primary outcome measures are serum TNF-alpha and IL-1 beta levels at 25h after surgery. The secondary outcome measures include serum levels of TNF-alpha, IL-1 beta, CXCL8, Th1/Th2 ratio (by calculating IFN gamma/IL-4) at 1h post surgery and serum levels of CXCL8, Th1/Th2 ratio at 25h post surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed Non-Small Cell Lung Carcinoma (NSCLC) and will have elective video-assisted thoracoscopic lobectomy surgery
  • ASA grade 1-2
  • BMI between 18 to 31 kg/m2

排除标准

  • with a history of thoracic surgery
  • Unwilling to receive transcutaneous electrical acupoint stimulation
  • BMI ≥ 32 kg/m2
  • Infection or scars at the acupoints
  • periphery nerve injury at the upper or lower limbs
  • Severe liver, renal, brain or lung disease
  • Drug abuse
  • Patients who cannot coordinate with investigators, such as dysphasia,severe infectious disease and disturbance of consciousness
  • Patients participating other trials

结局指标

主要结局

serum TNF-α level

时间窗: at 25 hour after surgery

serum IL-1β level

时间窗: at 25 hour after surgery

次要结局

  • serum CXCL8 level(at 25 hour after surgery)
  • serum Th1/Th2 ratio(at 25 hour after surgery)
  • serum TNF-α level(at 1 hour after surgery)
  • serum IL-1β level(at 1 hour after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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