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

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Propofol; Remifentanil

Criteria

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