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

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

SUBMITTER: Le Guen M

PROVIDER: S-EPMC5353801 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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

Le Guen Morgan M Herr Marie M Bizard Antoine A Bichon Caroline C Boichut Nathalie N Chazot Thierry T Liu Ngai N Ankri Joel J Fischler Marc M

Trials 20170316 1

<h4>Background</h4>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 bisp ...[more]

PMID: 28298244

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Project description:BACKGROUND:It is unknown to what extent hypotension frequently observed following administration of propofol for induction of general anesthesia is caused by overdosing propofol. Unlike clinical signs, electroencephalon-based cerebral monitoring allows to detect and quantify an overdose of hypnotics. Therefore, we tested whether the use of an electroencephalon-based cerebral monitoring will cause less hypotension following induction with propofol. METHODS:Subjects were randomly assigned to a bispectral index (BIS)-guided (target range 40-60) or to a weight-related (2 mg.kg-?1) manual administration of propofol for induction of general anesthesia. The primary endpoint was the incidence of hypotension following the administration of propofol. Secondary endpoints included the degree of hypotension and correlations between BIS and drop in mean arterial pressure (MAP). Incidences were analyzed with Fisher's Exact-test. RESULTS:Of the 240 patients enrolled into this study, 235 predominantly non-geriatric (median 48 years, 25th - 75th percentile 35-61 years) patients without severe concomitant disease (88% American Society of Anesthesiology physical status 1-2) undergoing ear, nose and throat surgery, ophthalmic surgery, and dermatologic surgery were analyzed. Patients who were manually administered propofol guided by BIS (n?=?120) compared to those who were given propofol by weight (n?=?115) did not differ concerning the incidence of hypotension (44% vs. 45%; p?=?0.87). Study groups were also similar regarding the maximal drop in MAP compared to baseline (33% vs. 30%) and the proportion of hypotensive events related to all measurements (17% vs. 19%). Final propofol induction doses in BIS group and NON-BIS group were similar (1.93 mg/kg vs. 2 mg/kg). There was no linear correlation between BIS and the drop in MAP at all times (r?<?0.2 for all) except for a weak one at 6 min (r?=?0.221). CONCLUSION:Results of our study suggest that a BIS-guided compared to a weight-adjusted manual administration of propofol for induction of general anesthesia in non-geriatric patients will not lower the incidence and degree of arterial hypotension. TRIAL REGISTRATION:German Registry of Clinical Trials ( DRKS00010544 ), retrospectively registered on August 4, 2016.

Project description:BackgroundReducing depth of anesthesia and anesthetic exposure may help prevent delirium, but trials have been conflicting. Most studies were conducted under general anesthesia or in cognitively impaired patients. It is unclear whether reducing depth of anesthesia beyond levels consistent with general anesthesia reduces delirium in cognitively intact patients. The authors' objective was to determine whether a bundled approach to reduce anesthetic agent exposure as determined by Bispectral Index (BIS) values (spinal anesthesia with targeted sedation based on BIS values) compared with general anesthesia (masked BIS) reduces delirium.MethodsImportant eligibility criteria for this parallel-arm randomized trial were patients 65 yr or greater undergoing lumbar spine fusion. The intervention group received spinal anesthesia with targeted sedation to BIS greater than 60 to 70. The control group received general anesthesia (masked BIS). The primary outcome was delirium using the Confusion Assessment Method daily through postoperative day 3, with blinded assessment.ResultsThe median age of 217 patients in the analysis was 72 (interquartile range, 69 to 77). The median BIS value in the spinal anesthesia with targeted sedation based on BIS values group was 62 (interquartile range, 53 to 70) and in the general anesthesia with masked BIS values group was 45 (interquartile range, 41 to 50; P < 0.001). Incident delirium was not different in the spinal anesthesia with targeted sedation based on BIS values group (25.2% [28 of 111] vs. the general anesthesia with masked BIS values group (18.9% [20 of 106]; P = 0.259; relative risk, 1.22 [95% CI, 0.85 to 1.76]). In prespecified subgroup analyses, the effect of anesthetic strategy differed according to the Mini-Mental State Examination, but not the Charlson Comorbidity Index or age. Two strokes occurred among patients receiving spinal anesthesia and one death among patients receiving general anesthesia.ConclusionsSpinal anesthesia with targeted sedation based on BIS values compared with general anesthesia with masked BIS values did not reduce delirium after lumbar fusion.Editor’s perspective

Project description:BackgroundAwareness with explicit recall of intra-operative events is a rare and distressing complication that may lead to severe psychological symptoms. Candidate depth of anesthesia monitors have been developed, partly with the aim of preventing this complication. Despite conflicting results from clinical trials and the lack of incisive validation, such monitors have enjoyed widespread clinical adoption, in particular the bispectral index. The American Society of Anesthesiologists has called for adequately powered and rigorously designed clinical trials to determine whether the use of such monitors decreases the incidence of awareness in various settings. The aim of this study is to determine with increased precision whether incorporating the bispectral index into a structured general anesthesia protocol decreases the incidence of awareness with explicit recall among a subset of surgical patients at increased risk for awareness and scheduled to receive an inhalation gas-based general anesthetic.Methods/designBAG-RECALL is a multi-center, randomized, controlled clinical trial, in which 6,000 patients are being assigned to bispectral index-guided anesthesia (target range, 40 to 60) or end-tidal anesthetic gas-guided anesthesia (target range, 0.7 to 1.3 age-adjusted minimum alveolar concentration). Postoperatively, patients are being assessed for explicit recall at two intervals (0 to 72 hours, and 30 days after extubation). The primary outcome of the trial is awareness with explicit recall. Secondary outcomes include postoperative mortality, psychological symptoms, intensive care and hospital length of stay, average anesthetic gas administration, postoperative pain and nausea and vomiting, duration of stay in the recovery area, intra-operative dreaming, and postoperative delirium.DiscussionThis trial has been designed to complement two other clinical trials: B-Unaware and MACS (ClinicalTrials.gov numbers, NCT00281489 and NCT00689091). With the large patient numbers and complementary rigorous designs, it is envisaged that pre-specified meta-analyses will address some of the outstanding controversies and questions relating to processed electroencephalography monitoring.Trial registrationClinicalTrials.gov Identifier: NCT00682825.

Project description:BackgroundThe proportion of older citizens is increasing worldwide. A well-known syndrome in old age is physical frailty which is associated with a greater risk of disabilities in activities of daily living, greater reliance on in-home services, hospitalization, institutionalization, and premature mortality. The purpose of this study is to determine the effects of an intervention with high-protein diet alone or in combination with power training in pre-frail and frail old adults.MethodsThe study is a community-based assessor-blinded parallel randomized controlled trial (RCT), consisting of two phases. Phase 1 is a 1-month stabilization phase, where self-reliant community-dwelling adults + 80 years old will receive individual guidance regarding protein intake, to prevent the risk of negative protein balance prior to phase 2 and to only include participants who have reached the minimum recommended level of protein intake (1.0 g/kg/day) in the randomized controlled trial. Phase 2 is a 4-month RCT where 150 participants will be randomized into the following three arms: protein-only where participants will be provided with dairy products to increase their protein intake to 1.5 g/kg/day, protein + exercise where participants will be provided with the protein intervention in combination with power training two times a week, and recommendation group where participants will continue as in phase 1. Primary outcome is lower leg muscle power. Secondary outcomes include physical function and mobility, frailty status, muscle mechanical function, body composition, nutritional status, and health-related quality of life. The statistical analysis will include an intention-to-treat analysis of all randomized participant and per-protocol analysis of all compliant participants. The study hypothesis will be tested with mixed linear models to assess changes in the main outcomes over time and between study arms.DiscussionThe finding of this study may add to the knowledge about the beneficial effects of high-protein diet from dairy products combined with power training to counteract frailty in community-dwelling older adults. This may ultimately have an impact on the ability to live well and independent for longer.Trial registrationClinicalTrials.gov NCT03842579 . Registered on 15 February 2019, version 1.

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

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

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