E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ventilated patients under intensive medical care with an expected duration of analgosedation of up to 7 days |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
|
|
E.2.2 | Secondary objectives of the trial |
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.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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”)
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |