Back to resultsComparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Morphine infusion
Fentanyl and Midazolam infusion
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Failure focused on measuring sedation, critical care, morphine, fentanyl, analgesic based sedation
Eligibility Criteria
Inclusion Criteria:
- Adults admitted to ICU requiring mechanical ventilation Informed consent
Exclusion Criteria:
- Less than 18 years old
- Consent denial
Sites / Locations
- Clinica de los Andes IPS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Morphine
Fentanyl and Midazolam
Arm Description
Control
Outcomes
Primary Outcome Measures
Time from sedation discontinuation to first T-Tube time from sedation
Secondary Outcome Measures
Time from sedation discontinuation to extubation time from sedation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01602640
Brief Title
Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit
Official Title
Sedation and Analgesia in Intensive Care: Comparison of Morphine and Fentanyl/Midazolam
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clínica de Los Andes IPS
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: Morphine infusion decreases time to mechanical ventilation weaning and extubation, as compared to the combination of fentanyl and midazolam in critically-ill patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
sedation, critical care, morphine, fentanyl, analgesic based sedation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morphine
Arm Type
Experimental
Arm Title
Fentanyl and Midazolam
Arm Type
Active Comparator
Arm Description
Control
Intervention Type
Drug
Intervention Name(s)
Morphine infusion
Intervention Description
Conventional dose
Intervention Type
Drug
Intervention Name(s)
Fentanyl and Midazolam infusion
Intervention Description
Conventional dose
Primary Outcome Measure Information:
Title
Time from sedation discontinuation to first T-Tube time from sedation
Time Frame
12-120 hours
Secondary Outcome Measure Information:
Title
Time from sedation discontinuation to extubation time from sedation
Time Frame
12-180 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults admitted to ICU requiring mechanical ventilation Informed consent
Exclusion Criteria:
Less than 18 years old
Consent denial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efrain Riveros, Principal investigator
Organizational Affiliation
Clinica de los Andes IPS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica de los Andes IPS
City
Tunja
State/Province
Boyaca
ZIP/Postal Code
8
Country
Colombia
12. IPD Sharing Statement
Learn more about this trial
Comparison of Morphine and Fentanyl/Midazolam in Intensive Care Unit
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