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临床试验/NCT02617680
NCT02617680已完成不适用

Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia

University Hospital Hradec Kralove1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
end tidal concentration of desflurane according to age

研究概览

简要总结

There is accumulating evidence that inappropriate depth of anaesthesia is associated with increased risk of postoperative complications including risk of death. The aim of this study was to identify factors determining the effective end-tidal concentration (EEtC) of desflurane, duration of wash in and wash out phase, and to estimate the risk of perioperative awareness in patients undergoing elective neurosurgical procedure.

详细描述

All patients with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective neurosurgical procedure under general anaesthesia are studied. In each individual, the manufacturer recommended age-corrected end-tidal concentrations of desflurane is set and achieved initially. Individual effective end-tidal concentration (EEtC) of desflurane is then defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50. Effective analgesia is maintained according to surgical plethysmographic index (SPI) and dose of muscle relaxants according to neuromuscular transmission monitoring (TOF). Comorbidity, regular intake of alcohol and medication, smoking, sex, weight, height, and age are recorded. Postoperative questionnaire is used to reveal the intraoperative awareness.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III
  • elective neurosurgical procedure under general anaesthesia
  • Age between 18 and 78
  • elective procedures with estimated duration 1 - 3 hours

排除标准

  • Glasgow coma scale GCS below 14
  • other rhythm than sinus
  • pacemaker stimulation
  • planned postoperative ventilation

研究组 & 干预措施

desflurane - oxygen in air

Experimental

The manufacturer recommended age-corrected end-tidal concentrations of desflurane in air should be set and achieved initially. Concentration of oxygen should be 50%.

干预措施: desflurane - oxygen in air (Drug)

desflurane - oxygen in nitric oxide

Experimental

The manufacturer recommended age-corrected end-tidal concentrations of desflurane with nitric oxide - oxygen should be set and achieved initially.Concentration of oxygen should be 50%.

干预措施: desflurane - oxygen in nitric oxide (Drug)

结局指标

主要结局

end tidal concentration of desflurane according to age

时间窗: from the start of procedure up to 4 hours

次要结局

  • Time to spontaneous ventilation(from end of anesthesia up to 1 hour)
  • Time to extubation(from the end of anesthesia up to 1 hour)
  • Time to reaction to command(from the end of anesthesia up to 1 hour)
  • Wash in phase(up to achievement of manufacturer age-corrected end-tidal concentrations of desflurane up to 10 minutes)
  • Wash out phase(from the end of procedure up to 1 hour)

研究者

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

Dostalova Vlasta, MD, PhD

Principal Investigator

University Hospital Hradec Kralove

研究点 (1)

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