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.

Autor: Brown CH 4th; Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Zayed 6208, 1800 Orleans St, Baltimore, MD, 21287, USA. cbrownv@jhmi.edu., Jones EL; Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Zayed 6208, 1800 Orleans St, Baltimore, MD, 21287, USA., Lin C; Mercy Anesthesiology Associates, 300 St. Paul Place, Baltimore, MD, 21202, USA., Esmaili M; Mercy Anesthesiology Associates, 300 St. Paul Place, Baltimore, MD, 21202, USA., Gorashi Y; Tufts University School of Medicine, 145 Harrison Ave, Boston, MA, 02111, USA., Skelton RA; University of Miami Miller School of Medicine, 1600 NW 10th avenue, Miami, FL, 33136, USA., Kaganov D; Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Zayed 6208, 1800 Orleans St, Baltimore, MD, 21287, USA., Colantuoni EA; Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD, 21287, USA., Yanek LR; Department of Medicine, Johns Hopkins University School of Medicine, 1830 Building; 8024, 600 N. Wolfe St, Baltimore, MD, 21287, USA., Neufeld KJ; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, A4 Center Suite 457, 4940 Eastern Avenue, Baltimore, MD, 21224, USA., Kamath V; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, A4 Center Suite 457, 4940 Eastern Avenue, Baltimore, MD, 21224, USA., Sieber FE; Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Zayed 6208, 1800 Orleans St, Baltimore, MD, 21287, USA., Dean CL; The Maryland Spine Center at Mercy, 301 St. Paul Place, Baltimore, MD, 21202, USA., Edwards CC 2nd; The Maryland Spine Center at Mercy, 301 St. Paul Place, Baltimore, MD, 21202, USA., Hogue CW; Department of Anesthesiology, Northwestern Feinberg School of Medicine, NMH/Feinberg Room 5-704, 251 E Huron, Northwestern Feinberg School of Medicine, Chicago, IL, 60611, USA.
Jazyk: angličtina
Zdroj: BMC anesthesiology [BMC Anesthesiol] 2019 Oct 27; Vol. 19 (1), pp. 192. Date of Electronic Publication: 2019 Oct 27.
DOI: 10.1186/s12871-019-0867-7
Abstrakt: 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.
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje