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Shaping anesthetic techniques to reduce post-operative delirium (SHARP) study: a protocol for a prospective pragmatic randomized controlled trial to evaluate spinal anesthesia with targeted sedation compared with general anesthesia in older adults undergoing lumbar spine fusion surgery.

ABSTRACT: BACKGROUND:Postoperative delirium is common in older adults, especially in those patients undergoing spine surgery, in whom it is estimated to occur in >?30% of patients. Although previously thought to be transient, it is now recognized that delirium is associated with both short- and long-term complications. Optimizing the depth of anesthesia may represent a modifiable strategy for delirium prevention. However, previous studies have generally not focused on reducing the depth of anesthesia beyond levels consistent with general anesthesia. Additionally, the results of prior studies have been conflicting. The primary aim of this study is to determine whether reduced depth of anesthesia using spinal anesthesia reduces the incidence of delirium after lumbar fusion surgery compared with general anesthesia. METHODS:This single-center randomized controlled trial is enrolling 218 older adults undergoing lumbar fusion surgery. Patients are randomized to reduced depth of anesthesia in the context of spinal anesthesia with targeted sedation using processed electroencephalogram monitoring versus general anesthesia without processed electroencephalogram monitoring. All patients are evaluated for delirium using the Confusion Assessment Method for 3?days after surgery or until discharge and undergo assessments of cognition, function, health-related quality of life, and pain at 3- and 12-months after surgery. The primary outcome is any occurrence of delirium. The main secondary outcome is change in the Mini-Mental Status Examination (or telephone equivalent) at 3-months after surgery. DISCUSSION:Delirium is an important complication after surgery in older adults. The results of this study will examine whether reduced depth of anesthesia using spinal anesthesia with targeted depth of sedation represents a modifiable intervention to reduce the incidence of delirium and other long-term outcomes. The results of this study will be presented at national meetings and published in peer-reviewed journals with the goal of improving perioperative outcomes for older adults. TRIAL REGISTRATION:Clinicaltrials.gov , NCT03133845. This study was submitted to Clinicaltrials.gov on October 23, 2015; however, it was not formally registered until April 28, 2017 due to formatting requirements from the registry, so the formal registration is retrospective.

SUBMITTER: Brown CH

PROVIDER: S-EPMC6815448 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Shaping anesthetic techniques to reduce post-operative delirium (SHARP) study: a protocol for a prospective pragmatic randomized controlled trial to evaluate spinal anesthesia with targeted sedation compared with general anesthesia in older adults undergoing lumbar spine fusion surgery.

Brown Charles H CH Jones Emily L EL Lin Charles C Esmaili Melody M Gorashi Yara Y Skelton Richard A RA Kaganov Daniel D Colantuoni Elizabeth A EA Yanek Lisa R LR Neufeld Karin J KJ Kamath Vidyulata V Sieber Frederick E FE Dean Clayton L CL Edwards Charles C CC Hogue Charles W CW

BMC anesthesiology 20191027 1

<h4>Background</h4>Postoperative delirium is common in older adults, especially in those patients undergoing spine surgery, in whom it is estimated to occur in > 30% of patients. Although previously thought to be transient, it is now recognized that delirium is associated with both short- and long-term complications. Optimizing the depth of anesthesia may represent a modifiable strategy for delirium prevention. However, previous studies have generally not focused on reducing the depth of anesthe ...[more]

PMID: 31656179

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Project description:ObjectiveTo test the equivalence for clinical effectiveness between microdecompression and laminectomy in patients with central lumbar spinal stenosis.DesignMulticentre observational study.SettingProspective data from the Norwegian Registry for Spine Surgery.Participants885 patients with central stenosis of the lumbar spine who underwent surgery at 34 Norwegian orthopaedic or neurosurgical departments. Patients were treated from October 2006 to December 2011.InterventionsLaminectomy and microdecompression.Main outcome measuresThe primary outcome was change in Oswestry disability index score one year after surgery. Secondary endpoints were quality of life (EuroQol EQ-5D), perioperative complications, and duration of surgical procedures and hospital stays. A blinded biostatistician performed predefined statistical analyses in unmatched and propensity matched cohorts.ResultsThe study was powered to detect a difference between the groups of eight points on the Oswestry disability index at one year. 721 patients (81%) completed the one year follow-up. Equivalence between microdecompression and laminectomy was shown for the Oswestry disability index (difference 1.3 points, 95% confidence interval -1.36 to 3.92, P<0.001 for equivalence). Equivalence was confirmed in the propensity matched cohort and full information regression analyses. No difference was found between groups in quality of life (EQ-5D) one year after surgery. The number of patients with complications was higher in the laminectomy group (15.0% v 9.8%, P=0.018), but after propensity matching for complications the groups did not differ (P=0.23). The duration of surgery for single level decompression was shorter in the microdecompression group (difference 11.2 minutes, 95% confidence interval 4.9 to 17.5, P<0.001), but after propensity matching the groups did not differ (P=0.15). Patients in the microdecompression group had shorter hospital stays, both for single level decompression (difference 1.5 days, 95% confidence interval 1.7 to 2.6, P<0.001) and two level decompression (0.8 days, 1.0 to 2.2, P=0.003).ConclusionAt one year the effectiveness of microdecompression is equivalent to laminectomy in the surgical treatment of central stenosis of the lumbar spine. Favourable outcomes were observed at one year in both treatment groups.Trial registration ClinicalTrials.gov NCT02006901.

Project description:PurposeTo characterize the inter- and intraobserver variability of qualitative, non-disk contour degenerative findings of the lumbar spine at magnetic resonance (MR) imaging.Materials and methodsThe case accrual method used to perform this institutional review board-approved, HIPAA-compliant retrospective study was the random selection of 111 interpretable MR examination cases of subjects from the Spine Patient Outcomes Research Trial. The subjects were aged 18-87 years (mean, 53 years +/- 16 [standard deviation]). Four independent readers rated the cases according to defined criteria. A subsample of 40 MR examination cases was selected for reevaluation at least 1 month later. The following findings were assessed: spondylolisthesis, disk degeneration, marrow endplate abnormality (Modic changes), posterior anular hyperintense zone (HIZ), and facet arthropathy. Inter- and intraobserver agreement in rating the data was summarized by using weighted kappa statistics.ResultsInterobserver agreement was good (kappa = 0.66) in rating disk degeneration and moderate in rating spondylolisthesis (kappa = 0.55), Modic changes (kappa = 0.59), facet arthropathy (kappa = 0.54), and posterior HIZ (kappa = 0.44). Interobserver agreement in rating the extent of Modic changes was moderate: kappa Values were 0.43 for determining superior anteroposterior extent, 0.47 for determining superior craniocaudal extent, 0.57 for determining inferior anteroposterior extent, and 0.48 for determining inferior craniocaudal extent. Intraobserver agreement was good in rating spondylolisthesis (kappa = 0.66), disk degeneration (kappa = 0.74), Modic changes (kappa = 0.64), facet arthropathy (kappa = 0.69), and posterior HIZ (kappa = 0.67). Intraobserver agreement in rating the extent of Modic changes was moderate, with kappa values of 0.54 for superior anteroposterior, 0.60 for inferior anteroposterior, 0.50 for superior craniocaudal, and 0.60 for inferior craniocaudal extent determinations.ConclusionThe interpretation of general lumbar spine MR characteristics has sufficient reliability to warrant the further evaluation of these features as potential prognostic indicators.

Dataset Information

Shaping anesthetic techniques to reduce post-operative delirium (SHARP) study: a protocol for a prospective pragmatic randomized controlled trial to evaluate spinal anesthesia with targeted sedation compared with general anesthesia in older adults undergoing lumbar spine fusion surgery.

Publications

Shaping anesthetic techniques to reduce post-operative delirium (SHARP) study: a protocol for a prospective pragmatic randomized controlled trial to evaluate spinal anesthesia with targeted sedation compared with general anesthesia in older adults undergoing lumbar spine fusion surgery.

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