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Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients

NCT00824239 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-06-11

No results posted yet for this study

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.

Conditions

  • Mechanical Ventilation

Interventions

PROCEDURE

Intermittent sedation

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).

PROCEDURE

Daily interruption of sedation

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.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Antonio Paulo Nassar Junior, MD · University of Sao Paulo

  • Marcelo Park, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00824239 on ClinicalTrials.gov