Stacie Deiner1,2,3, Xiaodong Luo4, Hung-Mo Lin1,5, Daniel I Sessler6,7, Leif Saager7, Frederick E Sieber8, Hochang B Lee9, Mary Sano6, Christopher Jankowski10, Sergio D Bergese11, Keith Candiotti12, Joseph H Flaherty13, Harendra Arora14, Aryeh Shander15, Peter Rock16. 1. Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York. 3. Department of Geriatrics and Palliative Care, Icahn School of Medicine at Mount Sinai, New York, New York. 4. Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York. 5. Department of Health Evidence and Policy, Icahn School of Medicine at Mount Sinai, New York, New York. 6. Department of Anesthesiology, Cleveland Clinic, Cleveland, Ohio. 7. Outcomes Research, Cleveland Clinic, Cleveland, Ohio. 8. Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins University, Baltimore, Maryland. 9. Department of Psychiatry, Yale University, New Haven, Connecticut. 10. Department of Anesthesiology and Preoperative Medicine, Mayo Clinic, Rochester, Minnesota. 11. Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, Ohio. 12. Department of Anesthesiology, Universityof Miami, Miami, Florida. 13. Department of Internal Medicine, Geriatrics Division, St Louis University Hospital, St Louis, Missouri. 14. Department of Anesthesiology, University of North Carolina School of Medicine, Chapel Hill, North Carolina. 15. Department of Anesthesiology, Englewood Hospital and Medical Center, Englewood, New Jersey. 16. Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, Maryland.
Abstract
IMPORTANCE: Postoperative 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. OBJECTIVE: To evaluate whether an intraoperative infusion of dexmedetomidine reduces postoperative delirium. DESIGN, SETTING, AND PARTICIPANTS: This 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. INTERVENTIONS: Dexmedetomidine infusion (0.5 µg/kg/h) during surgery and up to 2 hours in the recovery room. MAIN OUTCOMES AND MEASURES: The 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. RESULTS: In 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 RELEVANCE: Intraoperative 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 REGISTRATION: clinicaltrials.gov Identifier NCT00561678.
IMPORTANCE: Postoperative 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. OBJECTIVE: To evaluate whether an intraoperative infusion of dexmedetomidine reduces postoperative delirium. DESIGN, SETTING, AND PARTICIPANTS: This 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. INTERVENTIONS: Dexmedetomidine infusion (0.5 µg/kg/h) during surgery and up to 2 hours in the recovery room. MAIN OUTCOMES AND MEASURES: The 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. RESULTS: In 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 RELEVANCE: Intraoperative 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 REGISTRATION: clinicaltrials.gov Identifier NCT00561678.
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