Comparison of Lormetazepam and Midazolam Used as Sedatives for Patients That Require Intensive Care

NCT02022592 | Completed Phase 4

• 1 other identifier: LoveMi
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

A goal directed , demand-driven administration of sedative drugs is an integral part of every intensive care treatment. During long-term application of sedatives, Midazolam is the most commonly used sedative in Europe. One major objective is the problem of oversedation and agitation during an intensive care treatment due to the lack of controllability of available substances. The Love-Mi RCT investigates the clinical controllability of Midazolam versus the newly available intravenous drug Lormetazepam.

Conditions

Sedation in Intensive Care Unit Patients

Keywords

Sedation management; Midazolam; Lormetazepam; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• Controllability of sedation

  Controllability of sedation 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. . It will be measured until 5 days after terminationduring administration of study drug until 2 hours after its termination.

  Up to 50 hours

Secondary Outcomes (25)

• SOFA (Sequential Organ Failure Assessment)

  Up to 8 days

• Pain-Scores

  Up to 28 days

• Anxiety-Score

  Up to 28 days

• Concurrent medication for Analgesia and Sedation

  Up to 8 days

• Delirium-screening-Instruments

  Up to 28 days

Study Arms (2)

Lormetazepam

EXPERIMENTAL

The patient is treated on ICU not longer than 2 days. Dosage requirements according to Summary of product characteristics (Sedalam®).

Drug: Lormetazepam

Midazolam

ACTIVE COMPARATOR

The patient is treated on ICU not longer than 2 days. Dosage requirements according to Summary of product characteristics (Midazolam-ratiopharm®, Midazolam-hameln®).

Drug: Midazolam

Interventions

Lormetazepam DRUG

Lormetazepam

Midazolam DRUG

Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanically ventilated ICU patients with the need for sedatives to achieve or maintain the intended target-RASS (surgical/ nonsurgical).
• Age ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (3)

Clinic for Anesthesiology, Intensive Care Medicine and Painmanagement, Johann-Wolfgang-Goethe-University

Frankfurt, Frankfurt Am Main, 60590, Germany

Location

Clinic for Operative Intensive Care Medicine and Intermediate Care, University of RWTH

Aachen, 52056, Germany

Location

Department of Anesthesiology and Intensive Care Medicine, Charité - University Medicine

Berlin, 13353, Germany

Location

MeSH Terms

Interventions

lormetazepam; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Claudia Spies, MD, Univ.- Prof.

  Charite University, Berlin, Germany

  STUDY CHAIR

• Gernot Marx, MD, Univ.-Prof.

  University RWTH Aachen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med. C. Spies

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 30, 2013
• Study Start: July 17, 2014
• Primary Completion: December 12, 2019
• Study Completion: March 12, 2020
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

DE (3)