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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824239
• Other study ID #: 0284/08
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2009
• Last updated: June 8, 2012
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

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).
• 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.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas - University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator free-days		28 days	No
Secondary	Mortality		28 days	Yes
Secondary	Time of stay		ICU, hospitalar	No
Secondary	Self-extubation		28 days	Yes
Secondary	Reintubation		2 days after extubation	Yes
Secondary	Incidence of posttraumatic stress disorder		6 months	No
Secondary	Unplanned withdrawal of catheters		28 days	Yes