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Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

A Centre-Randomized, Open-Label, Cross-Over Study to Compare the Pharmaco-Economic Consequences of an Ultiva (Remifentanil Hydrochloride) Based Regimen With Conventional Sedative Based Regimens in ICU Subjects Requiring Short-Term Mechanical Ventilation With Analgesia and Sedation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00158873
Enrollment
224
Registered
2005-09-12
Start date
2004-09-30
Completion date
Unknown
Last updated
2008-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation

Keywords

ICU mechanical ventilation analgesia sedation

Brief summary

The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents.

Interventions

DRUGmidazolam
DRUGlorazepam
DRUGfentanyl
DRUGmorphine
DRUGremifentanil
DRUGpropofol

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation.

Exclusion criteria

* ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.

Design outcomes

Primary

MeasureTime frame
Health Outcome: Duration of time on mechanical ventilation

Secondary

MeasureTime frame
Health Outcome: length of stay in ICU, in hospital, requirement of opioid and sedative agents, duration of extubation process. Safety: haemodynamics and adverse events. Efficacy: sedation and pain scores

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026