Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 3

Conditions: Mechanical Ventilation

Treatments: Procedure: Daily interruption of sedation; Procedure: Intermittent sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT00824239

0284/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1. Intermittent sedation

Active Comparator group

Treatment:

Procedure: Intermittent sedation

2. Daily interruption of sedation

Active Comparator group

Treatment:

Procedure: Daily interruption of sedation