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

Phase 3

Terminated

Conditions: Analgesia

Interventions: Drug: Propofol
Drug: Remifentanil

Registration Number: NCT00436345

Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 39

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Propofol infusion
Remifentanil	Remifentanil	remifentanil

Primary Outcome Measures

Name	Time	Method
Duration of Time on Mechanical Ventilation (Per-Protocol Population)	Up to 38 days (912 hours)	Time from start of mechanical ventilation until actual extubation
Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)	Up to 38 days (912 hours)	Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).
Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)	Up to 38 days (912 hours)	Time from start of mechanical ventilation until actual extubation.

Secondary Outcome Measures

Name	Time	Method
Duration of Extubation	up to 38 days (912 hours)	Duration of extubation was measured.
Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator's Decision)	Up to 38 days (912 hours)	Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.
Duration of Weaning	up to 38 days (912 hours)	Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.
Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)	up to 10 days (240 hours)	Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Dose of Remifentanil Administered - Continuous Infusion	Up to 10 days	Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale	Up to 38 Days	Data from participants in the study for which the Sedation-Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Duration of Remifentanil Infusion (ITT Population)	Up to 10 days (240 hours)	Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Duration of Propofol Infusion (ITT Population)	up to 10 days (240 hours)	Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Doses of Sufentanil and Fentanil Administered - Continuous Infusion	up to 10 days	Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Dose of Morphine Administered - Continuous Infusion	up to 10 days	Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Total Dose of Propofol Administered - Bolus	Up to 10 days	Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Dose of Propofol Administered - Continuous Infusion	Up to 10 days	Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Total Dose of Fentanil Administered - Bolus	Up to 10 days	Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Sedation-Agitation for Day 7	Day 7	"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Sedation-Agitation From Day 8 to Day 10	Days 8, 9, and 10	"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Number of Participants Analyzed for BIS (Bispectral Index Scale)	Up to 38 days	Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Bispectral Index (BIS)	Screening through End of Study, up to 38 days	The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Bispectral Index (BIS) for Day 5	Day 5	The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Sedation-Agitation From Screening Through the End of Study	Up to 38 days	"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Bispectral Index (BIS) for Extubation Period and Post-Extubation Period	up to 38 days	The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Pain Intensity (PI)	Up to 38 days	"Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Pain Intensity From Day 8 to Day 10	Days 8, 9, and 10	"Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.