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临床试验/NCT02533388
NCT02533388已完成不适用

Effects of Transcutaneous Electrical Acupoint Stimulation on the Stress Response During Extubation After General Anesthesia in Elderly Patients Undergoing Elective Supratentorial Craniotomy

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12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in plasma concentrations of epinephrine

研究概览

简要总结

Elderly patients have an increased risk of stress responses during extubation after general anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses during extubation after general anaesthesia remains challenging for the anaesthesiologist. In this study, we aimed to investigate whether transcutaneous electrical acupoint stimulation (TEAS) might decrease the stress responses and improve the quality of recovery in the elderly patients who underwent elective supratentorial craniotomy under general anaesthesia.

详细描述

A total of 100 elderly patients scheduled for elective supratentorial craniotomy under propofol-remifentanil total intravenous anaesthesia were randomly divided to either TEAS group (received stimulation at LI4, PC6, LU7, LU5, LI18 and ST9 acupoints, 2/10Hz, 6-15 mA) or Sham group (received no stimulation). The primary outcomes were the haemodynamic parameters and plasma concentrations of epinephrine (E), norepinephrine (NE) and cortisol (Cor). The secondary outcomes were the consumption of remifentanil and propofol, the time from discontinuation of anesthetics to extubation and reorientation, extubation quality score, the quality of postoperative recovery and postoperative complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 60-70years
  • scheduled for elective supratentorial craniotomy under general anaesthesia

排除标准

  • past or current history of cardiovascular and/or cerebrovascular diseases
  • pre-existing liver, lung or kidney dysfunction
  • psychiatric disorders
  • potentially difficult airway
  • previous acupuncture treatment
  • infection at the stimulus sites

结局指标

主要结局

Change in plasma concentrations of epinephrine

时间窗: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

plasma concentrations of epinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Change in mean arterial blood pressure

时间窗: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Mean arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Change in heart rate

时间窗: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Heart rate was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Change in cortisol

时间窗: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Cortisol was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Change in Non-invasive arterial blood pressure

时间窗: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Non-invasive arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Change in norepinephrine

时间窗: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

Norepinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation

次要结局

  • Postoperative quality of recovery assessed by Quality of Recovery-40 questionnaire(QoR-40)(From discontinuation of anaesthetic drugs to 24 h after surgery)
  • the time to extubation,the time to reorientation(From discontinuation of anaesthetic drugs to 24 h after surgery)
  • The total amount of propofol that used throughout the surgery(From discontinuation of anaesthetic drugs to 24 h after surgery)
  • The total amount of remifentanil that used throughout the surgery(From discontinuation of anaesthetic drugs to 24 h after surgery)
  • the quality of extubation was evaluated by a 5-point Extubation Quality Score(From discontinuation of anaesthetic drugs to 24 h after surgery)
  • Postoperative complications,like cough,agitation,nausea and vomiting(From discontinuation of anaesthetic drugs to 24 h after surgery)

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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