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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: September 8, 2005
Last updated: October 15, 2008
Last verified: October 2008
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.

Condition Intervention Phase
Sedation Drug: midazolam Drug: lorazepam Drug: fentanyl Drug: morphine Drug: remifentanil Drug: propofol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Health Outcome: Duration of time on mechanical ventilation

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 224
Study Start Date: September 2004
Intervention Details:
    Drug: midazolam Drug: lorazepam Drug: fentanyl Drug: morphine Drug: remifentanil Drug: propofol
    Other Names:
    • midazolam
    • lorazepam
    • fentanyl
    • morphine
    • remifentanil

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00158873

GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Amsterdam, Netherlands, 1081 HV
GSK Investigational Site
Apeldoorn, Netherlands, 7334 DZ
GSK Investigational Site
Den Bosch, Netherlands, 5211 RW
GSK Investigational Site
Den Haag, Netherlands, 2512 VA
GSK Investigational Site
Dordrecht, Netherlands, 3318 AT
GSK Investigational Site
EDE, Netherlands, 6716 RP
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Haarlem, Netherlands, 2035 RC
GSK Investigational Site
Helmond, Netherlands, 5707 HA
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Rotterdam, Netherlands, 3015 GJ
GSK Investigational Site
Tiel, Netherlands, 4002 WP
GSK Investigational Site
Venlo, Netherlands, 5912 BL
GSK Investigational Site
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Study Director, GSK Identifier: NCT00158873     History of Changes
Other Study ID Numbers: 101653
Study First Received: September 8, 2005
Last Updated: October 15, 2008

Keywords provided by GlaxoSmithKline:
ICU mechanical ventilation analgesia sedation

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Gastrointestinal Agents processed this record on July 24, 2017