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临床试验/NCT01705743
NCT01705743已完成4 期

Minimum Alveolar Concentration of Sevoflurane With 60% Nitrous Oxide Inducing Isoelectric EEG in Mid-aged Adults

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
76
试验地点
1
主要终点
MACie

研究概览

简要总结

In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide on cerebral electrical activity, the investigators determined the MAC of sevoflurane combined with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.

详细描述

Anaesthesia was induced by sevoflurane in oxygen. Cisatracurium 0.15 mg kg-1 was administered after loss of the lash reflex, then ventilated manually until the amplitude of T1 decreased to 0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow of 2 L min-1. Anesthesia was maintained by sevoflurane or sevoflurane+60% nitrous oxide respectively. The surgical incision was performed at least 30 min after tracheal intubation, provided that the predetermined end-tidal sevoflurane concentration had been constant for at least 30 min and that the difference between inspired and end-tidal concentrations was less than 10%.

Brain electrical activity was measured using Narcotrend Monitor and S/5 Compact Anaesthesia Monitor, which displayed unprocessed EEG and burst suppression ratio, respectively. The design of the experiment is referred to the "Dixon up-and-down" method. To avid anaesthesia awareness, the first subject was designed to receive end-tidal sevoflurane concentration of 2.5 %. The presence or absence of isoelectric EEG (Entropy Module) of the preceding patient determined the end-tidal concentration of sevoflurane given to the next patient (with an increment size of 0.2%). The isoelectric EEG was considered as significant when the isoelectric state last for more than 1 min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached.

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
45 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • between 45 to 64 years old
  • ASA physical status class 1 or 2
  • elective abdominal surgery
  • Informed Consent

排除标准

  • history of neurological disease
  • received central nervous system-active drugs
  • cardiac ejection fraction less than 40%
  • history of difficult intubation or anticipated difficult intubation
  • daily alcohol consumption
  • obesity, defined as a body-mass index of more than 30
  • without informed consent
  • others judged inappropriate as subjects for the study by the Study Chair

研究组 & 干预措施

Group 1 Sevoflurane+Nitrous oxide

Active Comparator

干预措施: Sevoflurane+Nitrous oxide (Drug)

Group 2 Sevoflurane

Active Comparator

干预措施: Sevoflurane (Drug)

结局指标

主要结局

MACie

时间窗: 30min

Minimal Alveolar Concentration of sevoflurane and NO inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)

次要结局

未报告次要终点

研究者

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

Wei Mei

Associate Professor

Huazhong University of Science and Technology

研究点 (1)

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