To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Dexmedetomidine Reduces Infection Rate, Delirium, and ICU Length of Stay When Compared With Midazolam: Presented at ASA URL: http://www.pslgroup.com/dg/22F336.htm Doctor's Guide October 21, 2008
By Deborah Brauser ORLANDO, Fla -- October 21, 2008 -- Dexmedetomidine appears safe for long-term sedation while reducing intensive care unit (ICU) length of stay, incidence of delirium, and rate of infections compared with midazolam, according to a phase 4 study presented here at the American Society of Anesthesiologists (ASA) 2008 Annual Meeting. Paula Bokesch, MD, Hospira Inc., Lake Forest, Illinois, reported the results of this multicentre trial, which evaluated the safety and efficacy of dexmedetomidine in ventilated patients requiring more than 24 hours of sedation. The study was a multinational comparison of continuous infusion of dexmedetomidine versus continuous infusion of midazolam in critically ill ICU patients, Dr. Bokesch said in a presentation on October 20. For the trial, patients were enrolled at 68 ICUs in the United States, Argentina, New Zealand, Australia, and Brazil. All patients were randomised within 96 hours of intubation, receiving titrated infusions of either dexmedetomidine 0.2 to 1.4 mcg/kg/h or midazolam 0.02 to 0.1 mg/kg/h for 30 days or until extubation. Patients in the 2 groups were a mean age of 61.5 and 62.9 years, respectively, and men made up 51.2% and 46.7% of the groups, respectively. Of the 366 randomised patients, 194 of the 244 (79.5%) patients in the dexmedetomidine group and 103 of the 122 (84.4%) patients in the midazolam group received their study drug for 24 hours or longer, becoming the intent-to-treat (ITT) population. Sedation was assessed using Richmond Agitation-Sedation Scale (RASS) with a target range of -2 to +1, and delirium was assessed daily using the Confusion Assessment Method for the ICU (CAM-ICU). Results showed that the mean percentage of time that patients maintained the target sedation range was similar in the dexmedetomidine and midazolam treatment groups (80.8% vs 81.0%, respectively; P = .95). However, median time to extubation was 44.6 hours shorter for the dexmedetomidine group than the midazolam group (93.8 vs 138.4 hrs, P = .02), and median length of ICU stay was shorter by 1.6 days in the dexmedetomidine group (6.4 vs 8.0 days; P = .05). In addition, patients in the dexmedetomidine group had a significantly lower incidence of delirium during the study period compared with the midazolam group (54.6% vs 75.7%; P = .0004) and were significantly less likely to develop delirium (33.3% vs 55.3%; P = .0397). The dexmedetomidine-treated patients also had significantly fewer days of delirium than the other treatment group (1.4 days vs 2.7 days; P < .0001). At equal levels of sedation, dexmedetomidine resulted in a nearly 2-day shorter time to extubation and length of stay in ICU was shorter by more than 1 day, said Dr. Bokesch. The most profound finding was the effect of the drug on delirium in ICU, which is a significant problem in mechanically ventilated patients, she said. Results showed that dexmedetomidine decreased the daily incidence and the duration of delirium. No adverse effects were detected when dexmedetomidine was administered beyond 24 hours or at higher doses up to 1.4 mcg/kg/h. Adverse events were similar between the 2 groups, except for significantly more infections in the midazolam treatment group versus dexmedetomidine (19.7% vs 10.2%; P = .0149). Dr. Bokesch said that she was surprised by the effects of dexmedetomidine on delirium and the time to extubation. "Overall, I'd say that this drug is safe for long-term sedation ... and has significant clear clinical benefits in decreasing timed extubation, ICU length of stay, and infections." Funding for this study was provided by Hospira, Inc. [Presentation tile: Randomized, Double-Blind, Multicenter Study: Dexmedetomidine vs Midazolam for Sedation >24 Hours. Abstract A-497] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.