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:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT02022592
Eligibility Criteria:
Inclusion Criteria:
* Mechanically ventilated ICU patients with the need for sedatives to achieve or maintain the intended target-RASS (surgical/ nonsurgical).
* Age ≥ 18 years
* Patients who are incapable of giving consent at study inclusion: Written informed consent by patient's legal representative or an independent medical consultant, patients give informed consent subsequent if they are capable.
* Patients who are able to give informed consent at study inclusion: Written informed consent by patients for planned postoperative prolonged ventilatory support who undergo heart surgery
* Consensable patients for inclusion: with necessary intubation with analgosedation
Exclusion Criteria:
* Any bolus administration of benzodiazepines until 72hrs before inclusion (except from premedication due to anaesthesia).
* Continuous administration of benzodiazepines within the last 7 days before start of study drug application
* Titration phase: No way that a target RASS between -3 and 0 can be determined by the attending physician
* Known drug intolerance or allergy against lormetazepam, midazolam or one of the additional components.
* Addictive disorder
* Increased intracranial pressure
* Acute intoxication with alcohol, analgesics, sedatives, antipsychotics (neuroleptics, anti-depressives, lithium).
* Patients with cerebrale Pathology, which changes the controllability of sedation or die consciousness (e.g. patients known mental retardation due to syndromatic disorders or an infantile brain damage)
* Patients with a suspected or secured hypoxic brain damage
* Patients with intracranial surgery during actual hospital care
* Tetraplegic patients
* Myasthenia Gravis
* Cerebellar or spinal Ataxia
* Moribund patients with an expected lifespan of less than 24 hours.
* Sickle cell anaemia
* Thallassemia
* Enzyme related disorders that are associated with a severe decreased activity of UDP-glucoronyltransferase (e.g. M. Crigler- Najjar)
* Chronic liver insufficiency CHILD C with MELD Score \> 17 before access to intensive care unit
* Diagnosed propofol intolerance/anamnestic propofol infusion Syndrome
* Known depression/suicidality
* Pregnancy (positive beta-HCG test from urine or positive beta-HCG laboratory test from serum (in anuric patients the serum beta-HCG test is obliged) or lactation
* Woman of child-bearing potential who are not using a highly effective contraception (Pearl - Index \<1) until 3 months after study inclusion and during this trial
* Referral following an order of official authorities (court order or administrative decision) according to German Drug Law (AMG)
§40 (1) 4
* Participation in clinical trials according to the German Drug Law (AMG) 30 days to and during the study
* Local staff
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02022592
Study Brief:
Protocol Section:
NCT02022592