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临床试验/NCT02585284
NCT02585284已完成不适用

Effect of Age on Propofol-Bispectral Index Response Relationship Among Different Age Groups From Vicenarians to Nonagenarians. A New Logistic Model Compared With Traditional Sigmoid Emax Model

Suez Canal University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Difference in Bispectral Index value-TCI response curves

研究概览

简要总结

Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS) value of 46 before anaesthesia induction, and a 91-yr-old nonagenarian fully conscious at BIS value of 52 after propofol anaesthesia recovery. BIS algorithm was heuristically derived from a database of mostly "relatively fit, young healthy" volunteers. To date there are no studies precisely quantifying BIS response to propofol concentrations among different age groups

详细描述

Objective

Recently, reports appeared of an 88-yr-old octogenarian exhibiting bispectral index (BIS) value of 46 before anesthesia induction, and a 91-yr-old nonagenarian fully conscious at BIS value of 52 after propofol anesthesia recovery. BIS algorithm was heuristically derived from a database of mostly "relatively fit, young healthy" volunteers. To date there are no studies precisely quantifying BIS response to propofol concentrations among different age groups.

Methods: Investigators set Propofol estimated plasma concentrations (Cp) to gradually reach 3.5 microg·mL-1 over 3.5 min in 80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr). BIS values were fitted against Cp in our newly devised logistic model and traditional sigmoid Emax model. Raw BIS electroencephalography and measured propofol arterial samples determined whether changes are pharmacodynamic or pharmacokinetic asserted.

Propofol link to FDA site at FDA's Drugs@FDA web site. https://www.accessdata.fda.gov/scripts/cder/drugsatfda: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 80 patients, five male and five female, divided by age decades from vicenarian (20-29 yr) to nonagenarians (90-99 yr)

排除标准

  • Patients with liver disease

结局指标

主要结局

Difference in Bispectral Index value-TCI response curves

时间窗: During Induction 3.5 minutes

Gradual Induction with propofol over 3.5 minutes from 0 to 3.5 microgram ml-1

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

Ashraf Dahaba, MD

Principle Investigator

Suez Canal University

研究点 (1)

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