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Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hospital Sao Domingos.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Sao Domingos
ClinicalTrials.gov Identifier:
NCT01256866
First received: December 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

December 8, 2010
December 8, 2010
November 2010
October 2011   (final data collection date for primary outcome measure)
Incidence of delirium
Same as current
No Changes Posted
PERCENTAGE OF TIME WITHIN THE TARGET SEDATION
Same as current
Not Provided
Not Provided
 
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

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)

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mechanically Ventilated Patients
  • Sedation
  • Dexmedetomidine
  • Midazolam
  • Drug: Dexmedetomidine
  • Drug: Midazolam
  • Active Comparator: DEXMEDETOMIDINE, SEDATION
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Midazolam, sedation,
    Intervention: Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
146
June 2012
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult mechanically ventilated, critically ill patients

Exclusion Criteria:

  • pregnancy or lactation, severe liver disease, hearth rate less than 50, hypotension despite volemic repletion and vasoactive drug
Both
18 Years to 75 Years
No
Brazil
 
NCT01256866
hsd130947
Yes
Ethics Committee, Hospital Sao Domingos
Hospital Sao Domingos
Not Provided
Not Provided
Hospital Sao Domingos
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP