Abstract | IMPORTANCE: OBJECTIVE: 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: 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: TRIAL REGISTRATION: clinicaltrials.gov Identifier NCT00561678.
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Authors | Stacie Deiner, Xiaodong Luo, Hung-Mo Lin, Daniel I Sessler, Leif Saager, Frederick E Sieber, Hochang B Lee, Mary Sano, and the Dexlirium Writing Group, Christopher Jankowski, Sergio D Bergese, Keith Candiotti, Joseph H Flaherty, Harendra Arora, Aryeh Shander, Peter Rock |
Journal | JAMA surgery
(JAMA Surg)
Vol. 152
Issue 8
Pg. e171505
(Aug 16 2017)
ISSN: 2168-6262 [Electronic] United States |
PMID | 28593326
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Adrenergic alpha-2 Receptor Agonists
- Dexmedetomidine
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Topics |
- Adrenergic alpha-2 Receptor Agonists
(administration & dosage)
- Aged
- Cognitive Dysfunction
(prevention & control)
- Delirium
(prevention & control)
- Dexmedetomidine
(administration & dosage)
- Double-Blind Method
- Elective Surgical Procedures
(methods)
- Female
- Humans
- Infusions, Intravenous
- Intraoperative Care
(methods)
- Male
- Postoperative Complications
(prevention & control)
- Treatment Failure
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