NCT01256866

Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Hospital Sao Domingos · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Mechanically Ventilated Patients
• Sedation
• Dexmedetomidine
• Midazolam

Interventions

Type	Name	Description
DRUG	Dexmedetomidine
DRUG	Midazolam

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-10-01
• Completion: 2012-06-01
• First posted: 2010-12-09
• Last updated: 2010-12-09

Locations

1 site across 1 country: Brazil