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临床试验/NCT03140982
NCT03140982已完成不适用

Is Anesthetic Loss of Consciousness a Cortical or Brainstem Phenomenon? What Does the Neurological Examination Say?

Universidad del Desarrollo2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
loss of consciousness a cortical or brainsteam phenomenon

研究概览

简要总结

Using very slow or fast propofol intravenous injection, monitored using standard American Society of Anesthesiology (ASA) standard and SEDLine EEG (Med Tech), the patient was evaluate by a neurologist every 30 sec using the FOUR coma scale.

详细描述

Clinical experimental randomized study, approved by the Ethic Committee, with informed consent, included ASA I- II adults, without neurological illness and normal physical exam.

The patient randomized in two groups, rapid induction (GR) with propofol in target controlled infusion (TCI) effect site mode using the phamacokinetic (PK) model from Marsh ke0 1,21 min-1 using a calculated target of 5.4 ug/ml (loss of counsciousness EC95) and slow induction (GL) 10 mg/kg/h with calculated effect site concentrations (CeCALC) same PK model.

The same neurologist, blind to the correspondent group, evaluated all the patients every 30 sec using the coma FOUR scale until loss of counsciousness (LOC), defined as a FOUR (E0 no eyes opening response and /or M0 no motor response). At LOC the existance of brainstem reflex was evaluated (B no pupil and corneal reflex), respiratory pattern (R apnoea), CeCALC and patient state index (PSI) SEDline™ was recorded during all the examination.

After LOC in both groups we maintain in GR the initial target (5.3 ug/ml) and the LOC CeCALC during 10 min without intervention, except respiratory support if it was required.

Frontal EEG 4 channel and spectrogram from SEDline monitor was extracted for each case and posterior analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

after patient constent, and previos the patient arriving the OR, the care provider (designed anesthestist) using a coin decide the arm (GR or GL). The neurologist and investigator was blind to the arm.

入排标准

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

入选标准

  • ASA 1-2 patients programmed for elective surgery, normal neurologic examination -

排除标准

  • neurologic illness, receiving drugs that affect Central Nervous System during the last 48 hours

结局指标

主要结局

loss of consciousness a cortical or brainsteam phenomenon

时间窗: 1 year

with fast and slow induction we use the FOUR coma scale ( Ann Neurol. 2005;58(4): 585-93) to identify lost of brain stem activities.

次要结局

  • evaluation of the alfa band behavior after fast and slow inductions(1 year)

研究者

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

Pablo O. Sepulveda

MD. Professor in Anesthesia

Universidad del Desarrollo

研究点 (2)

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