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Frail Status of Elderly Patients After Repair and Anesthesia Guided by the bispectraL Index (FRAGIL)

2022年3月15日 更新者:Hopital Foch

Influence of the Modality of General Anesthesia Guided by the Bispectral Index (Manual or Automated) on the Occurrence of a Loss of Capability in Elderly Patients (> 70 Yrs): a Randomized Multicenter Study

The first aim of this study is to compare two methods of administration of intravenous anesthetics to obtain the same level of depth (bispectral index between 40 and 60): manual or automated and to determine a mid-term (6 months) influence of the frail phenotype on self-sufficient elderly patients after general anesthesia.

研究概览

详细说明

To date, patients over the age of 60 yrs represent 25% of the population and are at increased risk of surgical repair. Reduction of postoperative morbidity and mortality are now two main concerns for medical research. Dependence on caregivers and cognitive impairments are two major risks in the elderly and even more in frail patients after surgery under general anesthesia. In this context continuous monitoring of the depth of anesthesia through bispectral index may reduce its occurrence with better control of too deep sedation periods (vasopressors…). Previous studies by the investigators' team suggest a better duration in the expected interval of Bispectral Index with automated control of administration of intravenous anesthetics guided by Bispectral Index. This method remains to be tested in this high-risk population. As a consequence, a randomization into two groups will be carried on elderly patients (> 70 yrs): manual administration of anesthetics guided by Bispectral Index (manual group) or automated administration (automated group). Complete preoperative assessments will determine the FRAIL status (with a decrease in the physiological reserve) and abilities of the patient according to the self-sufficient scale. At six months a follow-up will determine the geriatric status of the patient to explore the rate of impairment and to examine predictive factors in the preoperative assessment. Finally, the influence of the method of administration will be reported. Four hundred and thirty patients will be included in this multicenter study with 215 patients per group and stratification of the presence of a cancer and of the abdominal repair. The follow-up in this study allows the patient or his/her relatives to keep in touch with a physician and to prescribe some therapy early if frailty or any other cognitive impairment appears.

研究类型

介入性

注册 (实际的)

134

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Besançon、法国、25030
        • Hôpital Jean Minjoz
      • Levallois-Perret、法国、92300
        • Institut Hopsitalier Franco-Britannique
      • Soyaux、法国、16800
        • Centre Clinical
      • Suresnes、法国、92150
        • Hôpital Foch

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

70年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult patients aged > 70 years old
  • American Society of Anesthesiologists class I to III
  • Scheduled for abdominal surgery under total intra-venous anesthesia
  • Self sufficient (living at home or in a non medical institution)
  • Written consent to the study

Exclusion Criteria:

  • Allergy to any intravenous agent (propofol or remifentanil)
  • Cognitive impairment with a Mini Mental State Examination < 20
  • Severe visual or hearing deficiency, apraxia
  • Restriction of the use of bispectral index

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Toolbox: Automated group

Toolbox: Automated administration of intravenous anesthetic (propofol 1%) and analgesic (remifentanil, Ultiva(r)) guided by the Bispectral index through a controller with a previously described algorithm.

Objective of depth anesthesia: 40-60

A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index
其他名称:
  • controller
有源比较器:Manual group

Manual administration of intravenous anesthetic (propofol 1%) and analgesic (remifentanil, Ultiva(r)) guided by the Bispectral index as usually performed in the operative theater.

Objective of depth anesthesia: 40-60

The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Rate of patients without occurrence of disability according to the InterRai scale
大体时间:6 months
Disability is evaluated using the InterRai scale; a death is considered as an irreversible disability institutionalization is considered as a severe disability InterRai scale would discriminate other patients
6 months

次要结果测量

结果测量
措施说明
大体时间
第 28 天的死亡率
大体时间:28天
28天
Mortality at month 6
大体时间:6 months
6 months
Rate of postoperative cognitive dysfunction
大体时间:6 months
Cognitive dysfunction is evaluated using the Mini Mental State examination
6 months
Incidence of pneumopathy
大体时间:6 months
Defined as a septic syndrome (fever) + increased number of polynuclear cells + typical image on chest X-ray + treatment with antibiotics
6 months
Incidence of pulmonary embolism
大体时间:6 months
Diagnosis on CT-scan with contrast injection
6 months
Incidence of postoperative myocardial infarction
大体时间:6 months
EKG modification and raised troponin
6 months
Incidence of evolution of the frail phenotype
大体时间:6 months
Frail phenotype accordingly to Fried Scale
6 months
Quality of the general anesthesia
大体时间:1 day
Defined as the time with a Bispectral Index in the interval 40-60
1 day
Performance of the automated system
大体时间:1 day
Defined according to the Varvell score
1 day
Presence of Suppression Ratio
大体时间:1 day
Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute
1 day
Occurrence of arterial hypotension requiring treatment
大体时间:1 day
Defined as a drop of 20% or more of the mean arterial pressure compared to the basal value measured before anesthetic induction and the requirement for a vasoactive agent
1 day
Patients'satisfaction about general anesthesia
大体时间:1 day
Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment)
1 day
Occurrence of awareness
大体时间:3 months
Postoperative specific questionnaire
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年7月7日

初级完成 (实际的)

2018年1月30日

研究完成 (实际的)

2018年1月30日

研究注册日期

首次提交

2015年8月10日

首先提交符合 QC 标准的

2015年8月13日

首次发布 (估计)

2015年8月14日

研究记录更新

最后更新发布 (实际的)

2022年3月16日

上次提交的符合 QC 标准的更新

2022年3月15日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2014/28
  • 2014-A01270-47 (其他标识符:ANSM)

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