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Does limiting sedation levels during hip fracture repair under spinal anesthesia reduce postoperative delirium overall or when stratified by baseline comorbidity?
In this randomized clinical trial that included 200 older patients randomized to receive lighter vs heavier sedation, limiting levels of sedation provided no significant overall benefit in reducing incident delirium. However, in a prespecified subgroup analysis, heavier vs lighter sedation levels doubled the risk of postoperative delirium in patients with low baseline comorbidities as defined by a Charlson comorbidity index score of 0.
Limiting intraoperative sedation levels may reduce delirium in older patients with low baseline comorbidity.
Postoperative delirium is the most common complication following major surgery in older patients. Intraoperative sedation levels are a possible modifiable risk factor for postoperative delirium.
To determine whether limiting sedation levels during spinal anesthesia reduces incident delirium overall.
Design, Setting, and Participants
This double-blind randomized clinical trial (A Strategy to Reduce the Incidence of Postoperative Delirum in Elderly Patients [STRIDE]) was conducted from November 18, 2011, to May 19, 2016, at a single academic medical center and included a consecutive sample of older patients (≥65 years) who were undergoing nonelective hip fracture repair with spinal anesthesia and propofol sedation. Patients were excluded for preoperative delirium or severe dementia. Of 538 hip fractures screened, 225 patients (41.8%) were eligible, 10 (1.9%) declined participation, 15 (2.8%) became ineligible between the time of consent and surgery, and 200 (37.2%) were randomized. The follow-up included postoperative days 1 to 5 or until hospital discharge.
Heavier (modified observer’s assessment of sedation score of 0-2) or lighter (observer’s assessment of sedation score of 3-5) propofol sedation levels intraoperatively.
Main Outcomes and Measures
Delirium on postoperative days 1 to 5 or until hospital discharge determined via consensus panel using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria. The incidence of delirium was compared between intervention groups with and without stratification by the Charlson comorbidity index (CCI).
Of 200 participants, the mean (SD) age was 82 (8) years, 146 (73%) were women, 194 (97%) were white, and the mean (SD) CCI was 1.5 (1.8). One hundred participants each were randomized to receive lighter sedation levels or heavier sedation levels. A good separation of intraoperative sedation levels was confirmed by multiple indices. The overall incident delirium risk was 36.5% (n = 73) and 39% (n = 39) vs 34% (n = 34) in heavier and lighter sedation groups, respectively (P = .46). Intention-to-treat analyses indicated no statistically significant difference between groups in the risk of incident delirium (log-rank test χ2, 0.46; P = .46). However, in a prespecified subgroup analysis, when stratified by CCI, sedation levels did effect the delirium risk (P for interaction = .04); in low comorbid states (CCI = 0), heavier vs lighter sedation levels doubled the risk of delirium (hazard ratio, 2.3; 95% CI, 1.1- 4.9). The level of sedation did not affect delirium risk with a CCI of more than 0.
Conclusions and Relevance
In the primary analysis, limiting the level of sedation provided no significant benefit in reducing incident delirium. However, in a prespecified subgroup analysis, lighter sedation levels benefitted reducing postoperative delirium for persons with a CCI of 0.
clinicaltrials.gov Identifier: NCT00590707
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Accepted for Publication: May 13, 2018.
Corresponding Author: Frederick E. Sieber, MD, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Bayview Medical Center, 4940 Eastern Ave, Baltimore, MD 21224 (firstname.lastname@example.org).
Published Online: August 8, 2018. doi:10.1001/jamasurg.2018.2602
Author Contributions: Drs Sieber and Wang had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Sieber, Neufeld, Gottschalk, Rosenberg, Mears, Stewart, Li, Wang.
Acquisition, analysis, or interpretation of data: Sieber, Neufeld, Gottschalk, Bigelow, Oh, Rosenberg, Mears, Stewart, Ouanes, Jaberi, Hasenboehler, Wang.
Drafting of the manuscript: Sieber, Gottschalk, Bigelow, Oh, Rosenberg, Wang.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Sieber, Wang.
Obtained funding: Sieber, Gottschalk, Wang.
Administrative, technical, or material support: Sieber, Neufeld, Gottschalk, Bigelow, Oh, Mears, Stewart, Ouanes.
Supervision: Sieber, Neufeld, Bigelow.
Other - classification interpretation of all included hip fractures: Hasenboehler.
Other - data management: Stewart.
Conflict of Interest Disclosures: None reported.
Funding/Support: This research was supported by National Institute on Aging grant R01 AG033615.
Role of the Funder/Sponsor: The National Institute of Aging had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Reducible Research Statement: Individual participant data that underlie the results reported in this article, study protocol, statistical analysis plan, and analytic code will be available for analysis after deidentification (text, tables, figures, and appendices) beginning 9 months and ending 36 months after article publication to researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to email@example.com. To gain access, data requestors will need to sign a data access agreement.
Additional Contributions: We thank the assessment team (Kori Kindbom, MA, Rachel Burns, BS, and Michael Sklar, MA, Johns Hopkins University School of Medicine) for their follow-up of patients. These individuals were part of the study assessment and follow-up team and were compensated for their services through the study’s National Institutes of Health grant. We also thank the data safety and monitoring board members (Jeffery Carson, MD, Rutgers University, Lee Fleisher, MD, University of Pennsylvania, Steve Epstein, MD, Georgetown University, Jay Magaziner, PhD, University of Maryland, Anne Lindblad, PhD, the Emmes Corporation, and Sarang Kim, MD, Rutgers University) for their time, effort, and oversight (see protocol) and Linda Sevier, Johns Hopkins Bayview Medical Center, for her preparation of the manuscript.
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