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Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Paulo Nassar Junior, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT00824239
First received: January 15, 2009
Last updated: June 8, 2012
Last verified: June 2012
History of Changes

January 15, 2009
June 8, 2012
September 2008
December 2011   (final data collection date for primary outcome measure)
Ventilator free-days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00824239 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Time of stay [ Time Frame: ICU, hospitalar ] [ Designated as safety issue: No ]
  • Self-extubation [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Reintubation [ Time Frame: 2 days after extubation ] [ Designated as safety issue: Yes ]
  • Incidence of posttraumatic stress disorder [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Unplanned withdrawal of catheters [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients
Randomized Trial Comparing Intermittent Sedation and Daily Interruption of Sedation in Mechanically Ventilated Patients

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Mechanical Ventilation
  • 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
  • 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
  • Active Comparator: 1. Intermittent sedation
    Intervention: Procedure: Intermittent sedation
  • Active Comparator: 2. Daily interruption of sedation
    Intervention: Procedure: Daily interruption of sedation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00824239
0284/08
Yes
Antonio Paulo Nassar Junior, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Antonio Paulo Nassar Junior, MD University of Sao Paulo
Study Director: Marcelo Park, PhD University of Sao Paulo
University of Sao Paulo General Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP