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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Intermittent sedation | Active Comparator |
| |
| 2. Daily interruption of sedation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator free-days | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28 days | |
| Time of stay | ICU, hospitalar | |
| Self-extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Paulo Nassar Junior, MD | University of Sao Paulo | Principal Investigator |
| Marcelo Park, PhD | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas - University of Sao Paulo | São Paulo | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24900938 | Derived | 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. |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D008874 | Midazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
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| 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. |
|
|
| 28 days |
| Reintubation | 2 days after extubation |
| Incidence of posttraumatic stress disorder | 6 months |
| Unplanned withdrawal of catheters | 28 days |
| D001552 |
| Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |