Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-28 @ 12:14 PM
Study NCT ID:
NCT01256866
Status:
UNKNOWN
Last Update Posted:
2010-12-09
First Post:
2010-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
Sponsor:
Hospital Sao Domingos
Organization:
Study Overview
Official Title:
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
Status:
UNKNOWN
Status Verified Date:
2010-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: