Clinical trial NCT00824239: Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients
Official title: Randomized Trial Comparing Intermittent Sedation and Daily Interruption of Sedation in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mechanical Ventilation
Keywords: critical care
sedation
Mechanically ventilated patients
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2009-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Ventilator free-days
timeFrame: 28 days
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
measure: Time of stay
timeFrame: ICU, hospitalar
measure: Self-extubation
timeFrame: 28 days
measure: Reintubation
timeFrame: 2 days after extubation
measure: Incidence of posttraumatic stress disorder
timeFrame: 6 months
measure: Unplanned withdrawal of catheters
timeFrame: 28 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Antonio Paulo Nassar Junior, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Marcelo Park, PhD
role: STUDY_DIRECTOR
References:
citation: Nassar Junior AP, Park M. Daily sedative interruption versus intermittent sedation in mechanically ventilated critically ill patients: a randomized trial. Ann Intensive Care. 2014 May 6;4:14. doi: 10.1186/2110-5820-4-14. eCollection 2014.