Last updated: 11/07/2018 19:49:13
A randomised, open-label, multicentre, parallel group study comparing the safety and efficacy of an Ultiva (remifentanil hydrochloride) based analgesia/sedation regimen with a conventional sedative-based regimen in long-term ICU subjects requiring analgesia and sedation for up to 10 days.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, open-label, multicentre, parallel group study comparing the safety and efficacy of an Ultiva (remifentanil hydrochloride) based analgesia/sedation regimen with a conventional sedative-based regimen in long-term ICU subjects requiring analgesia and sedation for up to 10 days.
Trial description: A randomised, open-label, multicentre, parallel group study comparing the safety and efficacy of an Ultiva (remifentanil hydrochloride) based analgesia/sedation regimen with a conventional sedative-based regimen in long-term ICU subjects requiring analgesia and sedation for up to 10 days.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Breen D, Karabinis A, Malbrain M et al. Decreased time on mechanical ventilation when comparing analgesia-based sedation using remifentanil versus standard hypnotic-based sedation for up to 10 days in intensive care unit patients: a randomised trial [ISRCTN47583497] Critical Care 2005 9: R200-R210.
Medical condition
Analgesia
Product
remifentanil
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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
Not applicable
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