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
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:
Enrollment:
164
Primary completion date:
2007-31-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
- INCLUSION CRITERIA
 - Written informed consent was obtained from the patient
 
Inclusion and exclusion criteria
Inclusion criteria:
- INCLUSION CRITERIA
 - Written informed consent was obtained from the patient
 - The patient is under intensive medical care, intubated and ventilated
 - The expected duration of ventilation and analgesia/sedation is > 24 hours and = 7 days
 - Propofol is planned to be used as sedative EXCLUSION CRITERIA
 - Contraindication against administration of remifentanil, sufentanil, or propofol
 - Concomitant medications:
 - The patient is receiving epidural analgesia or a peripheral regional anesthetic therapy.
 - The patient is requiring muscle relaxants to facilitate mechanical ventilation
 - The patient participated in clinical drug trials within the previous 30 days or participated in this clinical trial before or is currently participating in any other clinical trial
 - The patient has a known hypersensitivity to the drugs under investigation or to propofol (and other components of the preparation to be used), soy and peanut
 - For female patients: the patient is pregnant or breastfeeding
 - The patient is classified as ASA V or moribund
 - The patient must be expected to show an impaired cerebral or neurologic capacity due to illness, trauma or other interventions, which will interfere with the collection of the analgesia/sedation scores and the waking behavior as for example, without being limited to:
 - Hypoxic brain damage
 - Cerebrocranial trauma grades II, III, and IV
 - Subarachnoid hemorrhage, brain-stem hemorrhage, ischemic-hemorrhagic cerebral hemorrhages
 - Amyotrophic lateral sclerosis, myasthenia gravis
 - Stupor or coma
 - The patient requires chronic ventilation
 - The patient is receiving chronic (> 3 months) therapy with high-potency opioids/WHO level 3
 - The patient is alcohol or drug dependent (legal or illegal drugs in particular, but not exclusively with dependency on sedatives or benzodiazepines), defined as:
 - Typically an urgent desire to take the substance, problems in controlling consumption, and persistent use of the substance despite adverse consequences. The use of the substance has priority over other activities and responsibilities. Developing increased tolerance and occasionally physical withdrawal symptom.
 - The patient suffers from a manifest organ failure
 - The patient suffers from severe heart failure, NYHA Class IV (symptoms at rest)
 - The patient has a history of or actually suffers from ventricular tachycardia, ventricular flutter or ventricular fibrillation
 
Trial location(s)
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
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