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NCT Number: NCT00824239

Intermittent Sedation Versus 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.

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Key information

Conditions

Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital das Clinicas - University of Sao Paulo

São Paulo, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent sedation

Procedure

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 names: Fentanyl, midazolam, propofol

Daily interruption of sedation

Procedure

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 names: Fentanyl, midazolam, propofol

Primary outcomes

  1. Ventilator free-days

    Time frame: 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Randomized Trial Comparing Intermittent Sedation and Daily Interruption of Sedation in Mechanically Ventilated Patients

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 16, 2009
Registry last updated
Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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