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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation
conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
GSK Investigational Site
Catanzaro, Calabria, Italy
GSK Investigational Site
Napoli, Campania, Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy
GSK Investigational Site
Udine, Friuli Venezia Giulia, Italy
Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).
Time frame: Up to 38 days (912 hours)
Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)
Time from start of mechanical ventilation until actual extubation.
Time frame: Up to 38 days (912 hours)
Duration of Time on Mechanical Ventilation (Per-Protocol Population)
Time from start of mechanical ventilation until actual extubation
Time frame: Up to 38 days (912 hours)
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)
Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.
Time frame: Up to 38 days (912 hours)
Duration of Extubation
Duration of extubation was measured.
Time frame: up to 38 days (912 hours)
Duration of Weaning
Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.
Time frame: up to 38 days (912 hours)
Duration of Remifentanil Infusion (ITT Population)
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.
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GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Palermo, Sicily, Italy
Time frame: Up to 10 days (240 hours)
Duration of Propofol Infusion (ITT Population)
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.
Time frame: up to 10 days (240 hours)
Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)
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.
Time frame: up to 10 days (240 hours)
Dose of Remifentanil Administered - Continuous Infusion
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time frame: Up to 10 days
Doses of Sufentanil and Fentanil Administered - Continuous Infusion
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time frame: up to 10 days
Dose of Propofol Administered - Continuous Infusion
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time frame: Up to 10 days
Dose of Morphine Administered - Continuous Infusion
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time frame: up to 10 days
Total Dose of Propofol Administered - Bolus
Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time frame: Up to 10 days
Total Dose of Fentanil Administered - Bolus
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time frame: Up to 10 days
Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale
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.
Time frame: Up to 38 Days
Sedation-Agitation From Screening Through the End of Study
"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.
Time frame: Up to 38 days
Sedation-Agitation for 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.
Time frame: Day 7
Sedation-Agitation From Day 8 to Day 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.
Time frame: Days 8, 9, and 10
Number of Participants Analyzed for BIS (Bispectral Index Scale)
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.
Time frame: Up to 38 days
Bispectral Index (BIS)
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.
Time frame: Screening through End of Study, up to 38 days
Bispectral Index (BIS) for 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.
Time frame: Day 5
Bispectral Index (BIS) for Extubation Period and Post-Extubation Period
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.
Time frame: up to 38 days
Pain Intensity (PI)
"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.
Time frame: Up to 38 days
Pain Intensity From Day 8 to Day 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.
Time frame: Days 8, 9, and 10