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Frailty Related to Anesthesia guided by the Index "bispectraL" (FRAIL) study: study protocol for a randomized controlled trial.

Identifieur interne : 000C25 ( Main/Exploration ); précédent : 000C24; suivant : 000C26

Frailty Related to Anesthesia guided by the Index "bispectraL" (FRAIL) study: study protocol for a randomized controlled trial.

Auteurs : Morgan Le Guen [France] ; Marie Herr [France] ; Antoine Bizard [France] ; Caroline Bichon [France] ; Nathalie Boichut [France] ; Thierry Chazot [France] ; Ngai Liu [France] ; Joel Ankri [France] ; Marc Fischler [France]

Source :

RBID : pubmed:28298244

Descripteurs français

English descriptors

Abstract

BACKGROUND

Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medical research and practice. Dependence on caregivers and cognitive impairment represent two major risk factors in the elderly, especially in frail patients after surgery under general anesthesia. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of impairments by gaining better control of the anesthetic depth. The first aim of this study is to compare manual versus automated administration of intravenous anesthetics with regard to 6-month functional decline in persons aged 70 years and older. The secondary objective includes an evaluation of the influence of the frail phenotype on self-sufficiency in elderly patients after general anesthesia.

METHODS/DESIGN

After receiving ethical committee approval and written consent, a complete preoperative assessment of physiological reserve and self-sufficiency will be performed on patients more than 70 years old who are scheduled for surgery under general anesthesia. This evaluation will determine the patient's frailty status in three categories: robust, pre-frail, and frail. Then, patients will be randomized into two groups: manual administration of anesthetics guided by BIS sensor (manual group) or automated administration (automated group) with recording of the anesthesia. A second examination will be scheduled after 6 months to assess changes in functional abilities, cognitive functions, and frailty status. A priori calculation of sample size gives a population of 430 patients to be included in this multicenter trial.

DISCUSSION

This clinical study is designed to detect any postoperative complications and deaths related to the performance of the general anesthesia guided by the BIS sensor and the preoperative functional status of the elderly: robust, pre-frail, or frail.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02524327 . Registered on 10 August 2015.


DOI: 10.1186/s13063-017-1868-9
PubMed: 28298244
PubMed Central: PMC5353801


Affiliations:


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Le document en format XML

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<term>Age Factors (MeSH)</term>
<term>Aged (MeSH)</term>
<term>Anesthesia, General (adverse effects)</term>
<term>Anesthesia, General (mortality)</term>
<term>Clinical Protocols (MeSH)</term>
<term>Cognition (MeSH)</term>
<term>Consciousness Monitors (MeSH)</term>
<term>Exercise (MeSH)</term>
<term>Female (MeSH)</term>
<term>Frail Elderly (MeSH)</term>
<term>Frailty (diagnosis)</term>
<term>Frailty (mortality)</term>
<term>Frailty (physiopathology)</term>
<term>Frailty (psychology)</term>
<term>France (MeSH)</term>
<term>Geriatric Assessment (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Intraoperative Neurophysiological Monitoring (adverse effects)</term>
<term>Intraoperative Neurophysiological Monitoring (instrumentation)</term>
<term>Intraoperative Neurophysiological Monitoring (methods)</term>
<term>Male (MeSH)</term>
<term>Muscle Strength (MeSH)</term>
<term>Nutritional Status (MeSH)</term>
<term>Predictive Value of Tests (MeSH)</term>
<term>Research Design (MeSH)</term>
<term>Risk Factors (MeSH)</term>
<term>Single-Blind Method (MeSH)</term>
<term>Time Factors (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
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<term>Anesthésie générale (effets indésirables)</term>
<term>Anesthésie générale (mortalité)</term>
<term>Cognition (MeSH)</term>
<term>Exercice physique (MeSH)</term>
<term>Facteurs de risque (MeSH)</term>
<term>Facteurs temps (MeSH)</term>
<term>Facteurs âges (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Force musculaire (MeSH)</term>
<term>Fragilité (diagnostic)</term>
<term>Fragilité (mortalité)</term>
<term>Fragilité (physiopathologie)</term>
<term>Fragilité (psychologie)</term>
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<term>Humains (MeSH)</term>
<term>Moniteurs d'évaluation de la conscience (MeSH)</term>
<term>Monitorage neurophysiologique peropératoire (effets indésirables)</term>
<term>Monitorage neurophysiologique peropératoire (instrumentation)</term>
<term>Monitorage neurophysiologique peropératoire (méthodes)</term>
<term>Mâle (MeSH)</term>
<term>Méthode en simple aveugle (MeSH)</term>
<term>Personne âgée fragile (MeSH)</term>
<term>Plan de recherche (MeSH)</term>
<term>Protocoles cliniques (MeSH)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Sujet âgé (MeSH)</term>
<term>Valeur prédictive des tests (MeSH)</term>
<term>État nutritionnel (MeSH)</term>
<term>Évaluation gériatrique (MeSH)</term>
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<term>Anesthesia, General</term>
<term>Intraoperative Neurophysiological Monitoring</term>
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<term>Frailty</term>
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<term>Fragilité</term>
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<term>Anesthésie générale</term>
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<term>Intraoperative Neurophysiological Monitoring</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en">
<term>Anesthesia, General</term>
<term>Frailty</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr">
<term>Anesthésie générale</term>
<term>Fragilité</term>
</keywords>
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<term>Monitorage neurophysiologique peropératoire</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr">
<term>Fragilité</term>
</keywords>
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<term>Frailty</term>
</keywords>
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<term>Fragilité</term>
</keywords>
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<term>Frailty</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Age Factors</term>
<term>Aged</term>
<term>Clinical Protocols</term>
<term>Cognition</term>
<term>Consciousness Monitors</term>
<term>Exercise</term>
<term>Female</term>
<term>Frail Elderly</term>
<term>France</term>
<term>Geriatric Assessment</term>
<term>Humans</term>
<term>Male</term>
<term>Muscle Strength</term>
<term>Nutritional Status</term>
<term>Predictive Value of Tests</term>
<term>Research Design</term>
<term>Risk Factors</term>
<term>Single-Blind Method</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
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<term>Cognition</term>
<term>Exercice physique</term>
<term>Facteurs de risque</term>
<term>Facteurs temps</term>
<term>Facteurs âges</term>
<term>Femelle</term>
<term>Force musculaire</term>
<term>France</term>
<term>Humains</term>
<term>Moniteurs d'évaluation de la conscience</term>
<term>Monitorage neurophysiologique peropératoire</term>
<term>Mâle</term>
<term>Méthode en simple aveugle</term>
<term>Personne âgée fragile</term>
<term>Plan de recherche</term>
<term>Protocoles cliniques</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Valeur prédictive des tests</term>
<term>État nutritionnel</term>
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<div type="abstract" xml:lang="en">
<p>
<b>BACKGROUND</b>
</p>
<p>Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medical research and practice. Dependence on caregivers and cognitive impairment represent two major risk factors in the elderly, especially in frail patients after surgery under general anesthesia. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of impairments by gaining better control of the anesthetic depth. The first aim of this study is to compare manual versus automated administration of intravenous anesthetics with regard to 6-month functional decline in persons aged 70 years and older. The secondary objective includes an evaluation of the influence of the frail phenotype on self-sufficiency in elderly patients after general anesthesia.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS/DESIGN</b>
</p>
<p>After receiving ethical committee approval and written consent, a complete preoperative assessment of physiological reserve and self-sufficiency will be performed on patients more than 70 years old who are scheduled for surgery under general anesthesia. This evaluation will determine the patient's frailty status in three categories: robust, pre-frail, and frail. Then, patients will be randomized into two groups: manual administration of anesthetics guided by BIS sensor (manual group) or automated administration (automated group) with recording of the anesthesia. A second examination will be scheduled after 6 months to assess changes in functional abilities, cognitive functions, and frailty status. A priori calculation of sample size gives a population of 430 patients to be included in this multicenter trial.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>DISCUSSION</b>
</p>
<p>This clinical study is designed to detect any postoperative complications and deaths related to the performance of the general anesthesia guided by the BIS sensor and the preoperative functional status of the elderly: robust, pre-frail, or frail.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>TRIAL REGISTRATION</b>
</p>
<p>ClinicalTrials.gov, NCT02524327 . Registered on 10 August 2015.</p>
</div>
</front>
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<Month>11</Month>
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<AbstractText Label="BACKGROUND">Currently, patients older than 60 years of age represent 25% of the population and are at an increased risk during surgery. Therefore, reducing postoperative morbidity and mortality is a major concern in medical research and practice. Dependence on caregivers and cognitive impairment represent two major risk factors in the elderly, especially in frail patients after surgery under general anesthesia. In this context, continuous monitoring of the depth of anesthesia using a bispectral index (BIS) sensor may reduce the occurrence of impairments by gaining better control of the anesthetic depth. The first aim of this study is to compare manual versus automated administration of intravenous anesthetics with regard to 6-month functional decline in persons aged 70 years and older. The secondary objective includes an evaluation of the influence of the frail phenotype on self-sufficiency in elderly patients after general anesthesia.</AbstractText>
<AbstractText Label="METHODS/DESIGN">After receiving ethical committee approval and written consent, a complete preoperative assessment of physiological reserve and self-sufficiency will be performed on patients more than 70 years old who are scheduled for surgery under general anesthesia. This evaluation will determine the patient's frailty status in three categories: robust, pre-frail, and frail. Then, patients will be randomized into two groups: manual administration of anesthetics guided by BIS sensor (manual group) or automated administration (automated group) with recording of the anesthesia. A second examination will be scheduled after 6 months to assess changes in functional abilities, cognitive functions, and frailty status. A priori calculation of sample size gives a population of 430 patients to be included in this multicenter trial.</AbstractText>
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<Affiliation>UVSQ, UMR-S 1168, Université Versailles Saint-Quentin-en-Yvelines, Saint-Quentin-en-Yvelines, France.</Affiliation>
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<AffiliationInfo>
<Affiliation>INSERM, U1168 VIMA: Aging and chronic diseases. Epidemiological and public health approaches, Villejuif, France.</Affiliation>
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<AffiliationInfo>
<Affiliation>Département de Santé Publique, AP-HP, Hôpital Sainte Périne, Paris, France.</Affiliation>
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