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Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT00824239
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : June 11, 2012
Sponsor:
Information provided by (Responsible Party):
Antonio Paulo Nassar Junior, University of Sao Paulo General Hospital

Brief Summary:
Sedation is very important in critical care. Critically ill patients are submitted to many stressor factors that have potential to affect longterm outcomes. However, oversedation is associated with increased morbidity, including increased time of mechanical ventilation and ICU stay and longterm psychological complications. Daily interruption of sedation is associated with less time under mechanical ventilation and less posttraumatic stress disorder. Intermittent sedation, when compared with continuous sedation, is also associated with decreased time of mechanical ventilation. The aim of this study is to compare intermittent sedation with daily interruption. Our primary endpoint is free-days of mechanical ventilation in 28 days.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Procedure: Intermittent sedation Procedure: Daily interruption of sedation Phase 3

Detailed Description:
A comparison of intermittent sedation - keeping analgesia with fentanyl and midazolam or propofol as boluses if agitation (SAS 5 or more) after adequate analgesia - and daily interruption of sedation - analgesia with fentanyl and sedation wiht midazolam or propofol continuously with daily interruptions every morning until patients awake and can follow simple commands. Sedation is restarted in half previous dosage if agitation (SAS 5 or more) occur.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Intermittent Sedation and Daily Interruption of Sedation in Mechanically Ventilated Patients
Study Start Date : September 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Active Comparator: 1. Intermittent sedation Procedure: Intermittent sedation
Patients under intermittent sedation stay without any continuous sedation since intubation and/or admission but receive analgesics as needed and sedatives only when agitated (SAS of 5 or more).
Other Name: Fentanyl, midazolam, propofol

Active Comparator: 2. Daily interruption of sedation Procedure: Daily interruption of sedation
Patients under daily interruption of sedation stay on continuous sedation with midazolam and fentanyl and are submitted to a daily interruption of sedation to a neurological evaluation until they reach a SAS of 4 or more, then continuous sedation is re-started in the half previous dosage.
Other Name: Fentanyl, midazolam, propofol




Primary Outcome Measures :
  1. Ventilator free-days [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
  2. Time of stay [ Time Frame: ICU, hospitalar ]
  3. Self-extubation [ Time Frame: 28 days ]
  4. Reintubation [ Time Frame: 2 days after extubation ]
  5. Incidence of posttraumatic stress disorder [ Time Frame: 6 months ]
  6. Unplanned withdrawal of catheters [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients under mechanical ventilation with less of 24 hours and a expectative of stay intubated for more than 24 hours

Exclusion Criteria:

  • Intubation secondary to a neurological cause
  • Pregnant women
  • Severe asthma or COPD decompensation
  • Palliative care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824239


Locations
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Brazil
Hospital das Clinicas - University of Sao Paulo
Sao Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Antonio Paulo Nassar Junior, MD University of Sao Paulo
Study Director: Marcelo Park, PhD University of Sao Paulo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antonio Paulo Nassar Junior, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT00824239    
Other Study ID Numbers: 0284/08
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012
Keywords provided by Antonio Paulo Nassar Junior, University of Sao Paulo General Hospital:
critical care
sedation
Mechanically ventilated patients
Additional relevant MeSH terms:
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Fentanyl
Midazolam
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action