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临床试验/NCT01800578
NCT01800578已完成不适用

Relationships Between Bispectral Index (BIS), Implicit Memory Dream Recall and MAC in Blended Anaesthesia

Germano De Cosmo1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
correlation between BIS and free association test score

研究概览

简要总结

the aim of this study was to estimate the relations between Bispectral Index values and explicit or implicit memory or dreams during two different minimal alveolar concentration (MAC) of sevoflurane in patients undergoing blended anaesthesia for major abdominal surgery and ,in this way, estimate the possibility to reduce, in presence of a deep analgesia, like epidural analgesia, the requirement of halogenated volatile anesthetics.

详细描述

The decreased responsiveness to stimulation defines depth of anaesthesia which is a balance between effects of anaesthetic drugs and surgical stimulations.

Awareness is a rare occurrence with an incidence of 0,1-0,2 % , defined as postoperative recall of events occurring during general anaesthesia.

Different stages of awareness should be defined: conscious awareness with explicit recalls with pain; conscious awareness with explicit recalls without pain; conscious awareness without explicit recall and possible implicit recall; subconscious awareness without explicit recall and possible implicit recall; no awareness .

This memory can be traumatic and may result in developing a chronic posttraumatic stress disorder (PTSD) in more than half of subjects .

Some cases of awareness are caused by inadequate anesthesia and are potentially avoidable through the assessment of depth of hypnosis by an intraoperative monitoring , especially when muscle relaxants are used.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • native Italian speakers American society of anaesthesiologist physical status I-II -

排除标准

  • refusal of placement of epidural catheter neurological or psychiatric diseases hearing impairment use of drugs know to affect central nervous system coagulopathy heart conditions infections allergy to local anaesthetics liver or renal disease

结局指标

主要结局

correlation between BIS and free association test score

时间窗: every 15 min during anaesthesia and 24 h after emergency from anaesthesia

次要结局

  • MAC of sevoflurane necessary to avoid awareness(24 h after emergency from anaesthesia)

研究者

发起方
Germano De Cosmo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Germano De Cosmo

PhD

Catholic University of the Sacred Heart

研究点 (1)

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