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

Charles H Brown 4th, Emily L Jones, Charles Lin, Melody Esmaili, Yara Gorashi, Richard A Skelton, Daniel Kaganov, Elizabeth A Colantuoni, Lisa R Yanek, Karin J Neufeld, Vidyulata Kamath, Frederick E Sieber, Clayton L Dean, Charles C Edwards 2nd, Charles W Hogue, Charles H Brown 4th, Emily L Jones, Charles Lin, Melody Esmaili, Yara Gorashi, Richard A Skelton, Daniel Kaganov, Elizabeth A Colantuoni, Lisa R Yanek, Karin J Neufeld, Vidyulata Kamath, Frederick E Sieber, Clayton L Dean, Charles C Edwards 2nd, Charles W Hogue

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.

Keywords: Anesthesia; Delirium; General; Lumbar; Post-operative; Spinal; Spine; Surgery.

Conflict of interest statement

CB has consulted for and participated in a data share agreement with Medtronic.

KN has received fees from Merck Inc. and grant funding from Hitachi Inc. and Ornim Inc.

CH has received grants and consultant fees from Medtronic Inc., has been a consultant to Merck Inc., and received grants from the NIH.

This study was funded by grants from the International Anesthesia Research Society, the Johns Hopkins Clinician Scientist Award, NIH K23 AG051783, and K-76 AG057020.

Figures

Fig. 1
Fig. 1
Study Flow Diagram. A flow diagram of study procedures is shown, including screening, enrollment, randomization, intervention, and follow-up assessments

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Source: PubMed

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