Back to resultsSedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
Primary Purpose
Mechanically Ventilated Patients, Sedation, Dexmedetomidine
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Mechanically Ventilated Patients focused on measuring Dexmedetomidine, Midazolam, Sedation, Mechanical ventilation, Critically ill patients
Eligibility Criteria
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
Sites / Locations
- Hospital Sao DomingosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
DEXMEDETOMIDINE, SEDATION
Midazolam, sedation,
Arm Description
Outcomes
Primary Outcome Measures
Incidence of delirium
Secondary Outcome Measures
PERCENTAGE OF TIME WITHIN THE TARGET SEDATION
Full Information
NCT ID
NCT01256866
First Posted
December 8, 2010
Last Updated
December 8, 2010
Sponsor
Hospital Sao Domingos
1. Study Identification
Unique Protocol Identification Number
NCT01256866
Brief Title
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
Official Title
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Sao Domingos
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanically Ventilated Patients, Sedation, Dexmedetomidine, Midazolam
Keywords
Dexmedetomidine, Midazolam, Sedation, Mechanical ventilation, Critically ill patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DEXMEDETOMIDINE, SEDATION
Arm Type
Active Comparator
Arm Title
Midazolam, sedation,
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Midazolam
Primary Outcome Measure Information:
Title
Incidence of delirium
Secondary Outcome Measure Information:
Title
PERCENTAGE OF TIME WITHIN THE TARGET SEDATION
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Sao Domingos
City
Sao Luis
State/Province
Maranhao
ZIP/Postal Code
65060-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose R Azevedo, MD
Phone
55 98 32168110
Email
jrazevedo@elo.com.br
First Name & Middle Initial & Last Name & Degree
Jose R Azevedo, MD
First Name & Middle Initial & Last Name & Degree
Carla C Oliveira, RN
12. IPD Sharing Statement
Learn more about this trial
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
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