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Intermittent Sedation Versus Daily Interruption of Sedation in Mechanically Ventilated Patients

NCT ID: NCT00824239

Last Updated: 2012-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. Intermittent sedation

Group Type ACTIVE_COMPARATOR

Intermittent sedation

Intervention Type 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).

2. Daily interruption of sedation

Group Type ACTIVE_COMPARATOR

Daily interruption of sedation

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Fentanyl, midazolam, propofol Fentanyl, midazolam, propofol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Antonio Paulo Nassar Junior

Antonio Paulo Nassar Junior

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Paulo Nassar Junior, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Marcelo Park, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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Hospital das Clinicas - University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 24900938 (View on PubMed)

Other Identifiers

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0284/08

Identifier Type: -

Identifier Source: org_study_id

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