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Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a Prospective Observational Trial.

ABSTRACT: BACKGROUND:Elderly people are at particular high risk for postoperative delirium (POD) following spine surgery, which is associated with longer hospital stays, higher costs, risk for delayed complications, long-term care dependency, and cognitive dysfunction (POCD). It is insufficiently understood which mechanisms and risk factors contribute to the development of POD and POCD following these major but plannable surgeries. OBJECTIVE:This study aims to identify modifiable risk factors in spine surgery. A better understanding thereof would help adapt medical management and surgical strategies to individual risk profiles. METHODS:This is a single-center observational study jointly conducted by the departments of neurosurgery, neurology, and anesthesiology at a tertiary care hospital in Germany. All patients aged 60 years and older presenting to the neurosurgery outpatient clinic or ward for elective spine surgery are screened for eligibility. Exclusion criteria include presence of neurodegenerative or history of psychiatric disease and medication with significant central nervous system activity (eg, antidepressants, antipsychotics, sedatives). Surgical and anesthetic procedures including duration of surgery as primary end point of this study are thoroughly documented. All patients are furthermore evaluated for their preoperative cognitive abilities by a number of tests, including the Consortium to Establish a Registry for Alzheimer's Disease Plus test battery. Physical, mental, and social health and well-being are assessed using the Patient-Reported Outcome Measurement Information System Profile 29 and Hospital Anxiety and Depression Scale. Patients additionally receive preoperative cerebrovascular ultrasound and structural and functional brain imaging. The immediate postoperative period includes screening for POD using the Nursing Delirium Screening Scale and validation through Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, criteria. We furthermore investigate markers of (neuro)inflammation (eg, interleukins, C-reactive protein, tumor necrosis factor alpha). Preoperative examinations are repeated 3 months postoperatively to investigate the presence of POCD and its mechanisms. Statistical analyses will compare delirious and nondelirious patients for predictors of immediate (POD) and delayed (POCD) cognitive dysfunction. RESULTS:This is the first study to prospectively evaluate risk factors for POD and POCD in spine surgery. Recruitment is ongoing, and data collection is estimated to be finished with the inclusion of 200 patients by mid-2020. CONCLUSIONS:The identification of mechanisms, possibly common, underlying POD and POCD would be a major step toward defining effective interventional strategies early in or even before the postoperative period, including the adaptation of surgical strategies to individual risk profiles. TRIAL REGISTRATION:ClinicalTrials.gov NCT03486288; https://clinicaltrials.gov/ct2/show/NCT03486288. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15488.

SUBMITTER: Muller J

PROVIDER: S-EPMC7048391 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a Prospective Observational Trial.

Müller Jonas J Nowak Stephan S Vogelgesang Antje A von Sarnowski Bettina B Rathmann Eiko E Schmidt Sein S Rehberg Sebastian S Usichenko Taras T Kertscho Harry H Hahnenkamp Klaus K Flöel Agnes A Schroeder Henry Ws HW Müller Jan-Uwe JU Fleischmann Robert R

JMIR research protocols 20200213 2

<h4>Background</h4>Elderly people are at particular high risk for postoperative delirium (POD) following spine surgery, which is associated with longer hospital stays, higher costs, risk for delayed complications, long-term care dependency, and cognitive dysfunction (POCD). It is insufficiently understood which mechanisms and risk factors contribute to the development of POD and POCD following these major but plannable surgeries.<h4>Objective</h4>This study aims to identify modifiable risk facto ...[more]

PMID: 32053113

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Project description:BackgroundPostoperative delirium (POD) is common and has negative effects on elderly patients. There is a critical need to identify patients at high risk of POD so that providers can better offer targeted interventions in the preoperative and intraoperative periods. We aimed to characterize the prevalence of preoperative anxiety and investigate whether preoperative anxiety predicted the onset of POD in elderly patients undergoing elective orthopedic surgery.MethodsWe conducted a prospective observational cohort study of elderly patients (aged 65 years or older) undergoing elective orthopedic surgery. Preoperative anxiety was assessed using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A), with clinically significant values defined as HADS-A>7. POD was diagnosed according to the Confusion Assessment Method (CAM) criteria on the 5 postoperative days. To determine the independent risk factors for POD, multivariable logistic regression was conducted, including those variables with a p-value <0.05 at univariate analysis.ResultsThere were 263 patients included in the study. Seventy-three (27.8%) patients were diagnosed to be POD. Median duration of delirium was 2 days. Forty (15.2%) patients were assessed to experience preoperative anxiety. The occurrence of preoperative anxiety in total hip arthroplasty (THA), proximal femoral nail antirotation (PFNA), and total knee arthroplasty (TKA) was 12.5%, 16.1%, and 19.5%, respectively. Based on multivariable analysis, only age (odds ratio [OR]= 1.099, 95% Confidence Interval [CI]: 1.013-1.192; P=0.023), Mini Mental State Examination (MMSE) (OR= 0.603, 95% CI: 0.432-0.842; P=0.003) and preoperative anxiety (OR= 3.119, 95% CI: 1.144-8.500; P=0.026) were independently associated with POD.ConclusionIn conclusion, the current study reveals that preoperative anxiety helps to predict the risk of POD in elderly patients undergoing elective orthopedic surgery. Relieving preoperative anxiety could be a new target for preventive interventions to reduce POD.

Project description:IntroductionThe blood-brain barrier (BBB) disruption contributes to postoperative delirium, but cost-effective and non-invasive assessment of its permeability is not practicable in the clinical settings. Urine albumin to creatinine ratio (UACR), reflecting systemic vascular endothelial dysfunction, may be a prognostic and predictive factor associated with postoperative delirium. The aim was to analyze the relationship between UACR and postoperative delirium in elderly patients undergoing elective non-cardiac surgery.Materials and methodsThrough stratified random sampling, a cohort of 408 individuals aged 60 years and older scheduled for elective non-cardiac surgery were included between February and August 2019 in the single-center, prospective, observational study. The presence of delirium was assessed using the Confusion Assessment Method (CAM) or Confusion Assessment Method for the ICU (CAM-ICU) on the day of surgery, at 2 h after the surgery ending time and on the first 3 consecutive days with repeated twice-daily, with at least 6-h intervals between assessments. Urine samples were collected on one day before surgery, and 1st day and 3rd day after surgery. The primary outcome was the presence of postoperative delirium, and association of the level of UACR with postoperative delirium was evaluated with unadjusted/adjusted analyses and multivariable logistic regression.ResultsPostoperative delirium was observed in 26.75% (107 of 400) of patients within 3 days post-surgery. UACR-Pre (OR, 1.30; 95% CI, 1.14-1.49, p < 0.001), UACR-POD1 (OR, 1.20; 95% CI, 1.13-1.27, p < 0.001), and UACR-POD3 (OR, 1.14; 95% CI, 1.08-1.20, p < 0.001) between the delirium and non-delirium groups show a significant difference, even after adjusting for age, education levels, and other factors.ConclusionAs the marker of endothelial dysfunction, the high perioperative UACR value may be linked to the postoperative delirium in elderly patients undergoing elective non-cardiac surgery.

Project description:ImportancePostoperative delirium occurs in 10% to 60% of elderly patients having major surgery and is associated with longer hospital stays, increased hospital costs, and 1-year mortality. Emerging literature suggests that dexmedetomidine sedation in critical care units is associated with reduced incidence of delirium. However, intraoperative use of dexmedetomidine for prevention of delirium has not been well studied.ObjectiveTo evaluate whether an intraoperative infusion of dexmedetomidine reduces postoperative delirium.Design, setting, and participantsThis study was a multicenter, double-blind, randomized, placebo-controlled trial that randomly assigned patients to dexmedetomidine or saline placebo infused during surgery and for 2 hours in the recovery room. Patients were assessed daily for postoperative delirium (primary outcome) and secondarily for postoperative cognitive decline. Participants were elderly (>68 years) patients undergoing major elective noncardiac surgery. The study dates were February 2008 to May 2014.InterventionsDexmedetomidine infusion (0.5 µg/kg/h) during surgery and up to 2 hours in the recovery room.Main outcomes and measuresThe primary hypothesis tested was that intraoperative dexmedetomidine administration would reduce postoperative delirium. Secondarily, the study examined the correlation between dexmedetomidine use and postoperative cognitive change.ResultsIn total, 404 patients were randomized; 390 completed in-hospital delirium assessments (median [interquartile range] age, 74.0 [71.0-78.0] years; 51.3% [200 of 390] female). There was no difference in postoperative delirium between the dexmedetomidine and placebo groups (12.2% [23 of 189] vs 11.4% [23 of 201], P = .94). After adjustment for age and educational level, there was no difference in the postoperative cognitive performance between treatment groups at 3 months and 6 months. Adverse events were comparably distributed in the treatment groups.Conclusions and relevanceIntraoperative dexmedetomidine does not prevent postoperative delirium. The reduction in delirium previously demonstrated in numerous surgical intensive care unit studies was not observed, which underscores the importance of timing when administering the drug to prevent delirium.Trial registrationclinicaltrials.gov Identifier NCT00561678.

Dataset Information

Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a Prospective Observational Trial.

Publications

Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a Prospective Observational Trial.

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