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

Lormetazepam versus Midazolam used as sedatives for critically ill patients. - LoveMi

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000188-25-DE

Enrollment

Registered

2013-03-14

Start date

2013-10-23

Completion date

Unknown

Last updated

2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation

Interventions

Trade Name: SEDALAM® 2 mg/10 ml Pharmaceutical Form: Solution for infusion INN or Proposed INN: PR1: Lormetazepam CAS Number: 848-75-9 Other descriptive name: LORMETAZEPAM Concentration unit: mg/ml m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: “Controllability of sedation”; this is defined as the percentage share of measures where the actual depth of sedation (measured with the Richmond Agitation and Sedation Scale) (RASS)) matches the target depths of sedation. The individual sedation target is defined by the attending physician. ;Secondary Objective: 1) Incidence of newly developed complications 2) SOFA Score 3) Pain 4) Anxiety 5) Concurrent medication for Analgesia and Sedation 6) Delirium 7) Mortality 8) Duration of mechanical ventilation and weaning from mechanical ventilation 9) Length of ICU stay 10) Length of hospital stay 11) Discharge mode 12) Length of sedation 13) Number of changes in target sedation depth 14) Wake-up-time 15) Deviation from target sedation depth 16) Quality of Life 17) Cognition 18) Posttraumatic stress disorder 19) Pain threshhold measurement (only Center Charité and Gießen) 20) Depth of sedation (EMG/EEG) (surgery patients: Center Charité and Gießen, intensive care unit patients: Center Charité) 21) Photomotor reflex (only Center Charité) 22) Plasma activity of acetylcholine esterase 23) MicroRNA (only Center Charité) ;Primary end point(s): “Controllability of sedation”; this is defined as the percentage share of measures where the actual depth of sedation (measured with the Richmond Sedation and Agitation Scale (RASS)) matches the target depths of sedation. The individual sedation target is defined by the attending physician.;Timepoint(s) of evaluation of this end point: This endpoint will be measured for 3 days on ICU.	—

Measure

Time frame

Main Objective: “Controllability of sedation”; this is defined as the percentage share of measures where the actual depth of sedation (measured with the Richmond Agitation and Sedation Scale) (RASS)) matches the target depths of sedation. The individual sedation target is defined by the attending physician. ;Secondary Objective: 1) Incidence of newly developed complications 2) SOFA Score 3) Pain 4) Anxiety 5) Concurrent medication for Analgesia and Sedation 6) Delirium 7) Mortality 8) Duration of mechanical ventilation and weaning from mechanical ventilation 9) Length of ICU stay 10) Length of hospital stay 11) Discharge mode 12) Length of sedation 13) Number of changes in target sedation depth 14) Wake-up-time 15) Deviation from target sedation depth 16) Quality of Life 17) Cognition 18) Posttraumatic stress disorder 19) Pain threshhold measurement (only Center Charité and Gießen) 20) Depth of sedation (EMG/EEG) (surgery patients: Center Charité and Gießen, intensive care unit patients: Center Charité) 21) Photomotor reflex (only Center Charité) 22) Plasma activity of acetylcholine esterase 23) MicroRNA (only Center Charité) ;Primary end point(s): “Controllability of sedation”; this is defined as the percentage share of measures where the actual depth of sedation (measured with the Richmond Sedation and Agitation Scale (RASS)) matches the target depths of sedation. The individual sedation target is defined by the attending physician.;Timepoint(s) of evaluation of this end point: This endpoint will be measured for 3 days on ICU.

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Incidence of newly developed complications (cardiovascular, pulmonal, gastrointestinal, renal, cerebral und infectious) 2) SOFA 3) Pain-Scores (NRS-V; FPS-R; BPS; BPS-NI according to German consensus guidelines) 4) Anxiety-Score (FAS) 5) Concurrent medication for Analgesia and Sedation (dose/time) 6) Delirium-Screening-Instruments (CAM-ICU/ICDSC/Nu-DESC) 7) Mortality (days) 8) Duration of mechanical ventilation and weaning from mechanical ventilation (days) 9) Length of ICU stay (days) 10) Length of hospital stay (days) 11) Discharge mode (days) 12) Length of sedation (days) 13) Number of changes in target RASS 14) Wake-up-time (hours) 15) Deviation from target RASS 16) Quality of Life (EQ-5D) 17) Cognition (MMSE, FEDA, MWT) 18) Posttraumatic stress disorder (PTSS-14) 19) Pain threshold measurement (only Center Charité and Gießen) 20) Depth of sedation (EMG/EEG) (surgery patients at Center Charité and Gießen, intensive care unit patients at Center Charité) 21) Photomotor reflex (only Center Charité) 22) Plasma activity of acetylcholine esterase 23) MicroRNA (Center Charité) ;Timepoint(s) of evaluation of this end point: 1) will be measured until 5 days after termination of study drug . 13) and 14) and 15 ) will be measured until termination of study drug. 2) and 5) and 20) and 21) and 22) will be measured as long as patient is treated on ICU but not longer than 5 days after study drug termination. 3) and 4) and 6) will be measured until study day 28 or discharge. 18) MMSE and MWT and FEDA will be measured at 28 days (or discharge) and FEDA at 90 days. 8) and 9) and 10) and 11) and and 12) and 16) and 17) and 18) will be measured at follow up (day 90). 19) will be measured during the intervention of 2 days For 7) there will be a daily assessment and an assessment at follow up. 23) will be measured at inclusion and 24 hours later	—

Measure

Time frame

Secondary end point(s): 1) Incidence of newly developed complications (cardiovascular, pulmonal, gastrointestinal, renal, cerebral und infectious) 2) SOFA 3) Pain-Scores (NRS-V; FPS-R; BPS; BPS-NI according to German consensus guidelines) 4) Anxiety-Score (FAS) 5) Concurrent medication for Analgesia and Sedation (dose/time) 6) Delirium-Screening-Instruments (CAM-ICU/ICDSC/Nu-DESC) 7) Mortality (days) 8) Duration of mechanical ventilation and weaning from mechanical ventilation (days) 9) Length of ICU stay (days) 10) Length of hospital stay (days) 11) Discharge mode (days) 12) Length of sedation (days) 13) Number of changes in target RASS 14) Wake-up-time (hours) 15) Deviation from target RASS 16) Quality of Life (EQ-5D) 17) Cognition (MMSE, FEDA, MWT) 18) Posttraumatic stress disorder (PTSS-14) 19) Pain threshold measurement (only Center Charité and Gießen) 20) Depth of sedation (EMG/EEG) (surgery patients at Center Charité and Gießen, intensive care unit patients at Center Charité) 21) Photomotor reflex (only Center Charité) 22) Plasma activity of acetylcholine esterase 23) MicroRNA (Center Charité) ;Timepoint(s) of evaluation of this end point: 1) will be measured until 5 days after termination of study drug . 13) and 14) and 15 ) will be measured until termination of study drug. 2) and 5) and 20) and 21) and 22) will be measured as long as patient is treated on ICU but not longer than 5 days after study drug termination. 3) and 4) and 6) will be measured until study day 28 or discharge. 18) MMSE and MWT and FEDA will be measured at 28 days (or discharge) and FEDA at 90 days. 8) and 9) and 10) and 11) and and 12) and 16) and 17) and 18) will be measured at follow up (day 90). 19) will be measured during the intervention of 2 days For 7) there will be a daily assessment and an assessment at follow up. 23) will be measured at inclusion and 24 hours later

—

Countries

Germany

Contacts

Public ContactUniv.-Prof. Dr. C. Spies

Charité - Universitätsmedizin Berlin

claudia.spies@charite.de+4930551 001 / 02

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026