Ventilated patients under intensive medical care with an expected duration of analgosedation of up to 7 days
Conditions
Interventions
Trade Name: Ultiva 5 mg
Product Name: Ultiva 5 mg
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Remifentanilhydrochlorid
Concentration unit: mg milligram(s)
Concentration
Sponsors
GlaxoSmithKline GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient must not be included in this clinical trial unless all of the following inclusion criteria are fulfilled: 1. Written informed consent was obtained from the patient 2. The patient is under intensive medical care, intubated and ventilated 3. The expected duration of ventilation and analgosedation is > 24 hours and = 7 days 4. Propofol is intended to be used as sedativum 5. Age = 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient must not be included in this clinical trial if any of the exclusion criteria are fulfilled: 1. Contraindication against administration of remifentanil, sufentanyl, or propofol 2. Concomitant medications: • The patient is receiving epidural analgesia or a peripheral regional analgesic therapy. • The patient is requiring muscle relaxants to facilitate mechanical ventilation 3. The patient participated in clinical drug trials within the previous 30 days or par-ticipated in this clinical trial before or is currently participating in any other clinical trial 4. The patient has a known hypersensitivity to the drugs under investigation or to propofol 5. For female patients: the patient is pregnant or breastfeeding 6. The patient is classified as ASA V or moribund 7. 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 analgosedation scores and the waking behavior as for example, without be-ing limited to: • Hypoxic brain damage • Cerebrocanial trauma grades II, III, and IV • Subarachnoid hemorrhage, brain-stem hemorrhage, ischemic-hemorrhagic cerebral hemorrhages • Amyotrophic lateral sclerosis, myasthenia gravis • Stupor or coma 8. The patient requires chronic ventilation 9. The patient is receiving chronic (> 3 months) therapy with high-potency opioids / WHO level 3 10. 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 con-sumption, 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 symp-tom. 11. The patient suffers from an apparent organ failure 12. Patients with severe cardiac insufficiency or severe cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): • Time from initiation of analgosedation using the study substance and extubation (“ventilation time”) • Time from the start of weaning to extubation (“weaning time”) ;Main Objective: Main objective of the study is the comparison of two regimes for analgesie and sedation (Remifentanil/Propofol vs. Sufentanil/Propofol) concerning the duration of artificial respiration and weaning. ;Secondary Objective: Secondary objective of the trial are the comparisons of precision of analgesie and sedation, incidence of intercurrent complications, efficacy, duration of the intensive medical care, and the utilization of resources. | — |
Countries
Germany
Outcome results
None listed