Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00421720
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00421720
Study Brief:
Protocol Section:
NCT00421720