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Randomized Controlled Trial
. 2017 Mar 16;18(1):127.
doi: 10.1186/s13063-017-1868-9.

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

Morgan Le Guen  1 , Marie Herr  2   3   4 , Antoine Bizard  5 , Caroline Bichon  5 , Nathalie Boichut  6 , Thierry Chazot  7 , Ngai Liu  7 , Joel Ankri  2   3   4 , Marc Fischler  7
Affiliations
Randomized Controlled Trial

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

Morgan Le Guen et al. Trials. .

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.

Keywords: Anesthesia; Elderly; Frailty; Outcome; Recovery.

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Figures

Fig. 1
Fig. 1
Flowchart of the study setup
Fig. 2
Fig. 2
Example template of recommended content for the schedule of enrollment, interventions, and assessments
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