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

GlaxoSmithKline (GSK)

Status and phase

Terminated

Phase 3

Conditions

Analgesia

Treatments

Drug: Propofol

Drug: Remifentanil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00436345

108701

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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