The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen onmpared 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
ICU patients with mechanical ventilation requiring analgesia and sedation	Drug: midazolam  Drug: lorazepam  Drug: fentanyl  Drug: morphine  Drug: remifentanil  Drug: propofol	Phase IV

Further Study Details: 

Primary Outcomes: Health Outcome: Duration of time on mechanical ventilation
Secondary Outcomes: 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
Expected Total Enrollment:  224

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00158873

Netherlands
      GSK Clinical Trials Call Center, Hertogenbosch,  5200 ME,  Netherlands; No longer recruiting
      GSK Clinical Trials Call Center, Amsterdam,  1007 MB,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Zwolle,  8011 JW,  Netherlands; No longer recruiting
      GSK Clinical Trials Call Center, Tiel,  4002 WP,  Netherlands; No longer recruiting
      GSK Clinical Trials Call Center, Haarlem,  2035 RC,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Dordrecht,  3318 AT,  Netherlands; No longer recruiting
      GSK Clinical Trials Call Center, Rotterdam,  3015 GD,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Apeldoorn,  7334 DZ,  Netherlands; No longer recruiting
      GSK Clinical Trials Call Center, HELMOND,  5707 HA,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Hengelo,  7555 DL,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Ede,  6717 RP,  Netherlands; No longer recruiting
      GSK Clinical Trials Call Center, Eindhoven,  5623 EJ,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Den Haag,  2512 VA,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Alkmaar,  1815 JD,  Netherlands; No longer recruiting
      GSK Clinical Trials Call Center, Venlo,  5912 BL,  Netherlands; Recruiting

Study chairs or principal investigators

GSK Clinical Trials, MD,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  101653; UltiSAFE
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158873
Health Authority: Netherlands: Medicines Evaluation Board (MEB)
ClinicalTrials.gov processed this record on 2005-09-13