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临床试验/NCT02850471
NCT02850471暂停1 期

Pulmonary Protection of Transcutaneous Electrical Acupoint Stimulation in Gynecologic Laparoscopic Surgery

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
1 期
状态
暂停
入组人数
100
试验地点
1
主要终点
the change of blood pH

研究概览

简要总结

TEAS might protect against postoperative pulmonary such as ischemia-reperfusion injury (IRI) and atelectasis. We tested the hypothesis that transcutaneous electrical acupoint stimulation protects against postoperative pulmonary complications in patients who are receiving mechanical ventilation during general anesthesia for gynecologic laparoscopic surgery.

详细描述

Participants: 100 patients who underwent elective gynecologic laparoscopic surgery Methods: We recruited 100 patients who are planned for gynecologic laparoscopic surgery. Patients were enrolled from March 1, 2015. We randomly allocated patients into two groups: controlled group ( patients treated without transcutaneous electrical acupoint stimulation) and TEAS group (patients treated with TEAS on Feishu, Hegu, Chize half an hour before the surgery). Blood pH, Pco2, Po2 and oxygen saturation were measured by an automatic blood gas analyzer immediately after obtaining the samples from the aorta. Sample all the patients blood before and after the surgery. And then measure the level of TNF-α, IL-1β, and IL-6.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged from 65 to 75
  • The American Society of anesthesiologists (American Society of Anesthesiology, ASA) class Ⅱ ~ III
  • scheduled for gynecologic laparoscopic surgery under general anesthesia

排除标准

  • pre-existing lung or caridac disease
  • impaired kidney or liver function
  • history of bronchial asthma or chronic obstructive pulmonary disease
  • history of smoking
  • respiratory infection in the previous 2 weeks
  • preoperative use of bronchodilator, or a steroid

结局指标

主要结局

the change of blood pH

时间窗: intraoperative

the change of hemodynamic parameter MAP in mmHg

时间窗: intraoperative

the change of hemodynamic parameters HR in beat per minutes

时间窗: intraoperative

the change of blood SPO2 in percentage

时间窗: intraoperative

the change of blood PCO2 in mmHg

时间窗: intraoperative

the change of blood PO2 in mmHg

时间窗: intraoperative

次要结局

  • post-operative pulmonary complications(in the first 5 days after surgery)
  • the change of Plasma concentration of TNF-α in pg/mL(intraoperative)
  • the change of plasma concentration of IL-1β(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanchao Yang

resident doctor

Shengjing Hospital

研究点 (1)

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