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The aim of this prospective randomized study is to compare the safety and efficacy of two strategies for sedation of critically ill patients submitted to mechanical ventilation: continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The two groups will be compared as to the incidence of of delirium, evaluated with the Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or older intubated and mechanically ventilated for less than 48 hours prior to start of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146 patients (73 patients in each group)
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Hospital Sao Domingos
São Luís, Maranhão, Brazil
Start Date
November 1, 2010
Primary Completion Date
October 1, 2011
Completion Date
June 1, 2012
Last Updated
December 9, 2010
146
ESTIMATED participants
Dexmedetomidine
DRUG
Midazolam
DRUG
Lead Sponsor
Hospital Sao Domingos
NCT07461376
NCT07269808
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