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临床试验/NCT05019079
NCT05019079Unknown不适用

Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia

Lingling Ding0 个研究点目标入组 72 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
72
主要终点
oxygenation index

研究概览

简要总结

Objective to investigate the protective effect of preoperative electroacupuncture on lung function in patients with mechanical ventilation for more than 2 hours under general anesthesia

详细描述

Randomized parallel control study. From September 1, 2021 to December 31, 2022, patients with mechanical ventilation time more than 2 hours will be randomly divided into electroacupuncture pretreatment group and blank control group. The blood gas index, ventilator parameters and serum inflammatory factor concentration of patients will be evaluated to evaluate whether electroacupuncture has protective effect on lung function of patients with mechanical 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing general anesthesia in our hospital;
  • •Ages 18-60;
  • •American Society of Anesthesiologists (ASA) grade ⅱ ~ III , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
  • •Expected duration of operation >2h;
  • •Surgical grade 2-4;
  • •No serious lung infection and lung disease;
  • •Body mass index (BMI) 18~30 kg/m2; There are no contraindications for electroacupuncture stimulation.

排除标准

  • •Patients with severe circulatory or other system dysfunction;
  • •Patients with pulmonary and one-lung ventilation;
  • •Unwilling to cooperate with the patient;
  • •Patients with low compliance.

研究组 & 干预措施

electroacupuncture group

Experimental

In the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation was stopped 30min later.

干预措施: electroacupuncture (Other)

control group

No Intervention

The patient underwent routine anesthesia without acupuncture treatment

结局指标

主要结局

oxygenation index

时间窗: 5 minutes after tracheal intubation removal

record oxygenation index

oxygenation index

时间窗: Before anesthesia

record oxygenation index

oxygenation index

时间窗: 2 hours after tracheal intubation

record oxygenation index

次要结局

  • sedation score (Ramsay)(during anesthesia recovery period)
  • postoperative time in hospital(1 week after discharge, the patient's postoperative time in hospital will be recorded through medical record system)
  • Expression of IL-10 in serum(5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry)
  • extubation time(Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal)
  • anesthesia dosage(Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal)
  • visual analogue scale (VAS)(during anesthesia recovery period)
  • Expression of IL-1β in serum(5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry)
  • Mean arterial pressure(Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal)
  • BIS(Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal)
  • Postoperative comfort score(during anesthesia recovery period)
  • restfulness score (DRS)(during anesthesia recovery period)
  • Length of stay(1 week after discharge, the patient's length of stay will be recorded through medical record system)
  • mortality within 30 days(mortality within 30 days will be recorded)
  • heart rate(Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal)
  • postoperative complications of major organs(Major organ complications during hospitalization,assessed up to 30 days after surgery)
  • Expression of IL-18 in serum(5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry)
  • Expression of IL-18 in serum(Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry)
  • Expression of IL-1β in serum(Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry)
  • Expression of IL-10 in serum(Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry)

研究者

发起方
Lingling Ding
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lingling Ding

Professor

Beijing Hospital of Traditional Chinese Medicine

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