Last updated: 11/04/2018 13:04:27

A Study Comparing Two Analgesia/Sedation Regimens, Remifentanil/Propofol Versus Sufentanil/Propofol In Mechanically Ventilated Intensive Care Patients Requiring Analgesia And Sedation.

GSK study ID
USA107212
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, open-label, multicenter, parallel-group study to compare the efficacy, safety and resource utilization of a remifentanil/propofol analgesia/sedation regimen versus a sufentanil/propofol analgesia/sedation regimen in mechanically ventilated intensive care patients requiring analgesia and sedation for up to 7 days
Trial description: This prospective, randomized, multicenter, open-label study will compare two analgesia-based regimens for sedation (remifentanil/propofol vs. sufentanil/propofol) in medium to long-term ventilated intensive care patients in terms of efficacy, safety and resource utilization.
The special characteristics of intensive care patients (organ insufficiencies etc.) regularly cause an accumulation of the analgesics, sedatives and adjuvants used. Clinically, this complicates the calculation of weaning and extubation times, often making mechanical ventilation necessary for longer periods than desired and also extending the stay of patients in the intensive care unit. Reducing weaning times and the duration of intensive care treatment by optimizing analgesia/sedation could furthermore lead to a reduction in typical complications such as ventilator-associated pneumonia or delirium.
The demands on an ideal analgesic are analgesic efficacy without severe cardiopulmonary depression and rapid onset of effect and in particular a short dura-tion of effect and absence of accumulation or development of active metabolites. Remifentanil is an ultra-short acting µ-agonist which is, due to its molecular structure, metabolized organ-independently by unspecific blood and tissue esterases with the substance being degraded within only a few minutes and the resulting metabolites being virtually ineffective at the µ-receptor. Sufentanil, on the other hand, is mainly metabolized by the cytochrome P-450-3A4 enzyme in the liver and small intestine.
To date, only one study with a small sample size is available on the comparison of the effectiveness and safety of remifentanil and sufentanil when used for long-term analgesia/sedation.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Sufentanil
  • Drug: Remifentanil
  • Enrollment:
    164
    Primary completion date:
    2007-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Analgesia, Sedation
    Product
    remifentanil
    Collaborators
    Not applicable
    Study date(s)
    January 2007 to January 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • INCLUSION CRITERIA
    • Written informed consent was obtained from the patient

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Clinical Trials Call Center
    Homburg/Saar, N/A, Germany, 66421
    Status
    Terminated/Withdrawn
    Location
    GSK Clinical Trials Call Center
    Kiel, N/A, Germany, 24105
    Status
    Terminated/Withdrawn
    Location
    GSK Clinical Trials Call Center
    Heidelberg, N/A, Germany, 69120
    Status
    Terminated/Withdrawn
    Location
    GSK Clinical Trials Call Center
    Dresden, N/A, Germany, 01067
    Status
    Terminated/Withdrawn
    Location
    GSK Clinical Trials Call Center
    Bonn, N/A, Germany, 53105
    Status
    Terminated/Withdrawn
    Location
    GSK Clinical Trials Call Center
    Tubingen, N/A, Germany, 72076
    Status
    Terminated/Withdrawn
    Showing 1 - 6 of 10 Results

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    2007-31-01
    Actual study completion date
    2007-31-01

    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website