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

Analgesia Clinical Trial

Official title:

A Randomized, Open Label, Multicentre Study to Compare the Pharmaco-economic Implications of an Analgesia Based Regimen With Remifentanil and a Conventional Sedation Based Regimen Using Propofol in Medical and Post-surgical ICU Subjects Requiring Mechanical Ventilation for at Least 2 Days.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00436345
• Other study ID #: 108701
• Status: Terminated
• Phase: Phase 3
• First received: February 15, 2007
• Last updated: May 25, 2017
• Start date: November 2007
• Est. completion date: September 2008

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: September 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Remifentanil
analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation
• Propofol
conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical

Locations

Country	Name	City	State
Italy	GSK Investigational Site	Catanzaro	Calabria
Italy	GSK Investigational Site	Ferrara	Emilia-Romagna
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Udine	Friuli-Venezia-Giulia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to 38 days (912 hours)
Primary	Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)	Time from start of mechanical ventilation until actual extubation.	Up to 38 days (912 hours)
Primary	Duration of Time on Mechanical Ventilation (Per-Protocol Population)	Time from start of mechanical ventilation until actual extubation	Up to 38 days (912 hours)
Secondary	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.	Up to 38 days (912 hours)
Secondary	Duration of Extubation	Duration of extubation was measured.	up to 38 days (912 hours)
Secondary	Duration of Weaning	Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.	up to 38 days (912 hours)
Secondary	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.	Up to 10 days (240 hours)
Secondary	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.	up to 10 days (240 hours)
Secondary	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.	up to 10 days (240 hours)
Secondary	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.	Up to 10 days
Secondary	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.	up to 10 days
Secondary	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.	Up to 10 days
Secondary	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.	up to 10 days
Secondary	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.	Up to 10 days
Secondary	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.	Up to 10 days
Secondary	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.	Up to 38 Days
Secondary	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.	Up to 38 days
Secondary	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.	Day 7
Secondary	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.	Days 8, 9, and 10
Secondary	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.	Up to 38 days
Secondary	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.	Screening through End of Study, up to 38 days
Secondary	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.	Day 5
Secondary	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.	up to 38 days
Secondary	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.	Up to 38 days
Secondary	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.	Days 8, 9, and 10