Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients

Mechanical Ventilation Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanical Ventilation

• NCT number: NCT00824239
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Status: Completed
• Phase: Phase 3
• Start date: September 2008
• Completion date: December 2011