AnalgesiaPhase 3NCT00436345

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

A Phase 3 study testing Remifentanil and Propofol in people with Analgesia, run by GlaxoSmithKline at 6 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Analgesia
What is being tested?: Remifentanil and Propofol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 6 sitesItaly
Study dates: Nov 2007to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Italy6 sites

GSK Investigational Site
Catanzaro, Calabria, 88100
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100
GSK Investigational Site
Naples, Campania, 80131
GSK Investigational Site
Palermo, Sicily, 90127
GSK Investigational Site
Rome, Lazio, 00161
GSK Investigational Site
Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

About this study

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.

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.

Conditions: Analgesia
Being tested: Remifentanil, Propofol
Keywords: analgesia, Mechanical ventilation, pharmaco-economic, ICU
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemifentanilDrug
analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation
PropofolDrug
conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical

Study groups in NCT00436345
Study group	Role	What they receive
Remifentanil	Experimental	remifentanil Receives: Drug: Remifentanil
Propofol	Active comparator	Propofol infusion Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: Up to 38 days (912 hours)
Duration of Time on Mechanical Ventilation (Per-Protocol Population)
Time from start of mechanical ventilation until actual extubation
Measured: Up to 38 days (912 hours)

Secondary outcomes (22)

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.
Measured: Up to 38 days (912 hours)
Duration of Extubation
Duration of extubation was measured.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 8, 9, and 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Sep 2008

First posted19 Feb 2007 (estimated)
Study startNov 2007
Primary completionAug 2008
Study completionSep 2008

Why it stopped: recruitment issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnalgesiaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00436345
Sponsor's protocol ID: 108701
Status last verified: May 2017
First submitted: 15 Feb 2007
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00436345
Acronym / sponsor ID: 108701
Conditions: Analgesia
Keywords: analgesia, Mechanical ventilation, pharmaco-economic, ICU
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: recruitment issues
Enrolment: 39 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Aug 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 19 Feb 2007 (estimated)
Results: Posted 18 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Remifentanil	Experimental	Drug: Remifentanilremifentanil
Propofol	Active comparator	Drug: PropofolPropofol infusion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Remifentanilanalgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation	Drug	Remifentanil
Propofolconventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical	Drug	Propofol

Primary outcome

Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
Time frame: 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)
Time frame: Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation.
Duration of Time on Mechanical Ventilation (Per-Protocol Population)
Time frame: Up to 38 days (912 hours)
Time from start of mechanical ventilation until actual extubation

22 secondary outcomes

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)
Time frame: Up to 38 days (912 hours)
Duration of Extubation
Time frame: up to 38 days (912 hours)
Duration of Weaning
Time frame: up to 38 days (912 hours)
Duration of Remifentanil Infusion (ITT Population)
Time frame: Up to 10 days (240 hours)
Duration of Propofol Infusion (ITT Population)
Time frame: up to 10 days (240 hours)
Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)
Time frame: up to 10 days (240 hours)
Dose of Remifentanil Administered - Continuous Infusion
Time frame: Up to 10 days
Doses of Sufentanil and Fentanil Administered - Continuous Infusion
Time frame: up to 10 days
Dose of Propofol Administered - Continuous Infusion
Time frame: Up to 10 days
Dose of Morphine Administered - Continuous Infusion
Time frame: up to 10 days
Total Dose of Propofol Administered - Bolus
Time frame: Up to 10 days
Total Dose of Fentanil Administered - Bolus
Time frame: Up to 10 days
Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale
Time frame: Up to 38 Days
Sedation-Agitation From Screening Through the End of Study
Time frame: Up to 38 days
Sedation-Agitation for Day 7
Time frame: Day 7
Sedation-Agitation From Day 8 to Day 10
Time frame: Days 8, 9, and 10
Number of Participants Analyzed for BIS (Bispectral Index Scale)
Time frame: Up to 38 days
Bispectral Index (BIS)
Time frame: Screening through End of Study, up to 38 days
Bispectral Index (BIS) for Day 5
Time frame: Day 5
Bispectral Index (BIS) for Extubation Period and Post-Extubation Period
Time frame: up to 38 days
Pain Intensity (PI)
Time frame: Up to 38 days
Pain Intensity From Day 8 to Day 10
Time frame: Days 8, 9, and 10

Results and safety

Results posted to the registry on 18 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remifentanil	21	18
Propofol	18	18

Primary outcome: Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)

Time frame: Up to 38 days (912 hours). Mean (Standard Error). Unit: Hours (hr)

Measure	Remifentanil n = 21	Propofol n = 18
Value	77 (8.31)	70 (6.48)

Population analysed: Intent-to-Treat (ITT) Population: all randomised participants who had taken at least one dose of study medication

Primary outcome: Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)

Time frame: Up to 38 days (912 hours). Mean (Standard Error). Unit: Hours

Measure	Remifentanil n = 21	Propofol n = 18
Value	77 (8.31)	70 (6.48)

Population analysed: Modified-Intent-to-Treat (mITT) Population: all randomised participants who had taken at least one dose of study medication and who had efficacy measurements

Primary outcome: Duration of Time on Mechanical Ventilation (Per-Protocol Population)

Time frame: Up to 38 days (912 hours). Mean (Standard Error). Unit: Hours

Measure	Remifentanil n = 11	Propofol n = 13
Value	87 (9.47)	81 (4.71)

Population analysed: Per-Protocol (PP) Population: all participants from the MITT population without any major protocol violation

22 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remifentanil	0 of 21 (0%)	6 of ?	Not reported
Propofol	0 of 18 (0%)	3 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remifentanil and Propofol in people with Analgesia, run by GlaxoSmithKline at 6 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Time on Mechanical Ventilation (Intent-to-Treat Population) (time frame: Up to 38 days (912 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00436345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.