Comparison of Lormetazepam and Midazolam used as sedatives for patients that require intensive care.

Phase 1

• Conditions: Sedation; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-000188-25-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-14
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

-Mechanically ventilated ICU patients with the need for sedatives
to achieve or maintain the intended target-RASS (surgical/ non-surgical).
-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 general surgery
- Patients who are able to give informed consent at study inclusion and have the need for intubation with analgosedation

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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 possibility that the target RASS (-3 - 0) can be set by the treating 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 insuffiviency 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 monthes 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified