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Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)

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ClinicalTrials.gov Identifier: NCT01059929
Recruitment Status : Terminated (drug and placebo unavailable)
First Posted : February 1, 2010
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Mechanical Ventilation
Critical Illness
Interventions Drug: Dexmedetomidine
Drug: Propofol
Drug: Fentanyl
Drug: Midazolam
Behavioral: Physical and Occupational Therapy
Enrollment 41

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Period Title: Overall Study
Started 20 21
Completed 20 21
Not Completed 0 0
Arm/Group Title Dexmedetomidine Propofol Total
Hide Arm/Group Description

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Total of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 41 participants
60.5
(33 to 87)
67
(21 to 89)
63.8
(21 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Female
11
  55.0%
9
  42.9%
20
  48.8%
Male
9
  45.0%
12
  57.1%
21
  51.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.0%
0
   0.0%
1
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  40.0%
11
  52.4%
19
  46.3%
White
11
  55.0%
10
  47.6%
21
  51.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Proportion of Days With Delirium
Hide Description delirium assessment using CAM-ICU
Time Frame daily up to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to inability to maintain study drug supply in investigational pharmacy.
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Median (Inter-Quartile Range)
Unit of Measure: proportion of days
0
(0 to 0.71)
.33
(0.13 to 0.71)
2.Secondary Outcome
Title Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score
Hide Description Richmond Agitation Sedation Scale (RASS). This is a validated scale that measures level of sedation. The scale ranges from -5 to +4. -5 refers to a state where one is unarousable, +4 refers to a state where one is combative. The median and inter-quartile range over all daily assessments will be provided.
Time Frame Daily up to day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
-1
(-1 to -0.57)
-1.6
(-3.23 to -1)
3.Secondary Outcome
Title Number of Patients Completing Mobility Milestones
Hide Description Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently
Time Frame Daily through day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
7
  35.0%
6
  28.6%
4.Secondary Outcome
Title Days on Ventilator
Hide Description [Not Specified]
Time Frame 60 days from enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Median (Inter-Quartile Range)
Unit of Measure: days
3.85
(2.28 to 16.6)
4.05
(2.54 to 11.49)
5.Secondary Outcome
Title Days in ICU
Hide Description [Not Specified]
Time Frame 60 days from enollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Median (Inter-Quartile Range)
Unit of Measure: days
6.39
(3.64 to 17.6)
5.61
(2.88 to 11.22)
6.Secondary Outcome
Title Mortality
Hide Description [Not Specified]
Time Frame 28 days from enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
8
  40.0%
12
  57.1%
7.Secondary Outcome
Title Number of Participants With ICU Complications
Hide Description [Not Specified]
Time Frame daily through day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Patients Requiring Fentanyl
Hide Description [Not Specified]
Time Frame during infusion of study medication up to day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
3
  15.0%
6
  28.6%
9.Secondary Outcome
Title Number of Patients Requiring Midazolam
Hide Description [Not Specified]
Time Frame during infusion of study medication through day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
3
  15.0%
0
   0.0%
10.Secondary Outcome
Title Days in Hospital
Hide Description [Not Specified]
Time Frame 60 days from enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Median (Inter-Quartile Range)
Unit of Measure: days
14.33
(6.3 to 32.39)
12.96
(4.83 to 20.82)
11.Secondary Outcome
Title Number of Patients Completing Activities of Daily Living
Hide Description activities of daily living: eating, bathing, dressing, grooming, toileting
Time Frame daily through day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
7
  35.0%
6
  28.6%
12.Secondary Outcome
Title Number of Adverse Medication Effects
Hide Description [Not Specified]
Time Frame duration of infusion of study medication up to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description:

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Overall Number of Participants Analyzed 20 21
Measure Type: Number
Unit of Measure: number of events
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexmedetomidine Propofol
Hide Arm/Group Description

Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Dexmedetomidine: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.

Propofol: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

Fentanyl: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Midazolam: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)

Physical and Occupational Therapy: Daily therapy sessions targeting range of motion, strength, and mobility

All-Cause Mortality
Dexmedetomidine Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexmedetomidine Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexmedetomidine Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John Kress
Organization: University of Chicago
Phone: 773-702-6790
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01059929     History of Changes
Other Study ID Numbers: 16865B
First Submitted: September 14, 2009
First Posted: February 1, 2010
Results First Submitted: November 1, 2016
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018