Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-09-30

Brief Summary

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This study will be a multicentre randomized, open-label, phase IIIb study. This study will evaluate two different techniques of sedation: an analgesia based regimen with remifentanil versus a conventional sedation based regimen using propofol in subjects that require mechanical ventilation for at least 2 days in the ICU. The conventional sedation based regimen will consist of propofol combined with an opioid according to routine clinical practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen will consist of remifentanil, with propofol added on if required.

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Detailed Description

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Conditions

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Analgesia

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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Remifentanil

remifentanil

Group Type EXPERIMENTAL

Remifentanil

Intervention Type DRUG

analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation

Propofol

Propofol infusion

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical

Interventions

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Remifentanil

analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation

Intervention Type DRUG

Propofol

conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
* Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
* Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.

Exclusion Criteria

* Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
* Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided
* Concurrent medications:

* Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation
* Has or is likely to receive an epidural block during the treatment period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No