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临床试验/NCT03503578
NCT03503578已完成2 期

Electroencephalogram Studies of Induction and Recovery From Sevoflurane-Induced General Anesthesia

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia

研究概览

简要总结

The investigators are performing this research study to find out how and where the anesthetic drugs sevoflurane and ketamine act in the brain. Sevoflurane and ketamine are anesthetics (a drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness). The investigators will study the brain using a machine that records the brain's electrical activity, called an electroencephalogram (EEG).

详细描述

During this research study, participants will receive sevoflurane, and sevoflurane and ketamine together, at a high enough dose to induce general anesthesia (make study participants "fall asleep"). During one visit participants will receive only sevoflurane; during another visit participants will be given both sevoflurane and ketamine together. The investigators will record EEG the entire time. The investigators will also ask some questions related to pain and cognitive function.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18 and 50
  • Normal body weight and habitus, BMI ≤ 30
  • Non-smoker
  • American Society of Anesthesiologists (ASA) physical status classification P1

排除标准

  • Chronic health conditions

研究组 & 干预措施

EEG Dynamics

Experimental

EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.

干预措施: Ketamine (Drug)

EEG Dynamics

Experimental

EEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia

时间窗: Approximately 60 minutes

Changes in power from baseline at various EEG spectral frequencies were assessed at sevoflurane-induced loss of responsiveness. EEGs of 12 patients were analyzed to determine changes in various EEG spectral frequencies (alpha, theta, delta, etc.) from baseline. The outcome measure reflects the associated frequency (Hz) at which changes were found under sevoflurane-induced general anesthesia. These frequency values are a representation of the findings for all 12 participants.

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

Oluwaseun Johnson-Akeju, MD, MMSc

Associate Professor of Anaesthesia

Massachusetts General Hospital

研究点 (1)

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EEG Studies of Sevoflurane-Induced General Anesthesia | 临床试验