Last updated: 11/02/2018 23:38:31
Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: midazolam
Drug: lorazepam
Drug: fentanyl
Drug: morphine
Drug: remifentanil
Drug: propofol
Enrollment:
224
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sedation
Product
remifentanil
Collaborators
Not applicable
Study date(s)
September 2004 to October 2005
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
no
- ICU patients with an expected duration of mechanical ventilation for 2 to 3 days and requiring analgesia and sedation.
- ICU patients resuscitated in the previous 24 hours, neurotrauma or expecting major surgery, not likely to survive of with limit care status.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-21-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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