NCT03860129

Brief Summary

The MIRUS system (TIM, Andernach, Germany) as well as the AnaConDa uses a reflector to conserve volatile anaesthetics (VA). Both systems can be paired with ICU ventilators, but MIRUS features an automated control of end-tidal VA concentrations (etVA). We compare depth of 0.5 MAC inhalational long-term sedation with Isoflurane (ISO), Sevoflurane (SEVO) or Desflurane (DES).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2017

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

2.4 years

First QC Date

September 24, 2018

Last Update Submit

February 28, 2019

Conditions

Intensive Care Unit Syndrome

Keywords

inhalational Sedation

Outcome Measures

Primary Outcomes (1)

  • usage of volatile anesthetics at 0.5 MAC during ICU Sedation

    Comparison between Isofluarne, Sevoflurane and Desflurane

    up to one week

Study Arms (3)

ISO

OTHER

Drug name: Isoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (0.5 Vol%)

Drug: Isoflurane

SEVO

OTHER

Drug name: Sevoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (1.0 Vol%)

Drug: Sevoflurane

DES

OTHER

Drug name: Desflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (3.0 Vol%)

Drug: Desflurane

Interventions

IsofluraneDRUG

Group A: Isoflurane (0.5 MAC)

Also known as: Forene
ISO
SevofluraneDRUG

Group B: Sevoflurane (0.5 MAC)

Also known as: Sevorane
SEVO
DesfluraneDRUG

Group C: Desflurane (0.5 MAC)

Also known as: Suprane
DES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signing of the informed consent document (patient or relatives).
  • Patient age 18 years or older.
  • ASA I-III

You may not qualify if:

  • ASA IV patients
  • Epidural or spinal analgesia
  • Allergy or known hypersensitivity to any of the study drugs
  • Patients with known or suspected genetic susceptibility to malignant hyperthermia
  • Previous participation in this trial
  • Participation in another clinical trial within 4 weeks prior to selection.
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Bomberg H, Glas M, Groesdonk VH, Bellgardt M, Schwarz J, Volk T, Meiser A. A novel device for target controlled administration and reflection of desflurane--the Mirus. Anaesthesia. 2014 Nov;69(11):1241-50. doi: 10.1111/anae.12798. Epub 2014 Jul 9.

    PMID: 25040673BACKGROUND

  • Romagnoli S, Chelazzi C, Villa G, Zagli G, Benvenuti F, Mancinelli P, Arcangeli G, Dugheri S, Bonari A, Tofani L, Belardinelli A, De Gaudio AR. The New MIRUS System for Short-Term Sedation in Postsurgical ICU Patients. Crit Care Med. 2017 Sep;45(9):e925-e931. doi: 10.1097/CCM.0000000000002465.

    PMID: 28441236BACKGROUND

  • Bellgardt M, Drees D, Vinnikov V, Procopiuc L, Meiser A, Bomberg H, Gude P, Vogelsang H, Weber TP, Herzog-Niescery J. Use of the MIRUS system for general anaesthesia during surgery: a comparison of isoflurane, sevoflurane and desflurane. J Clin Monit Comput. 2018 Aug;32(4):623-627. doi: 10.1007/s10877-018-0138-z. Epub 2018 Apr 9.

    PMID: 29633099BACKGROUND

  • Georgevici AI, Kyprianou T, Herzog-Niescery J, Procopiuc L, Loganathan S, Weber TP, Bellgardt M. Negative drift of sedation depth in critically ill patients receiving constant minimum alveolar concentration of isoflurane, sevoflurane, or desflurane: a randomized controlled trial. Crit Care. 2021 Apr 13;25(1):141. doi: 10.1186/s13054-021-03556-y.

    PMID: 33849618DERIVED

  • Bellgardt M, Georgevici AI, Klutzny M, Drees D, Meiser A, Gude P, Vogelsang H, Weber TP, Herzog-Niescery J. Use of MIRUS for MAC-driven application of isoflurane, sevoflurane, and desflurane in postoperative ICU patients: a randomized controlled trial. Ann Intensive Care. 2019 Oct 16;9(1):118. doi: 10.1186/s13613-019-0594-8.

    PMID: 31620921DERIVED

MeSH Terms

Interventions

IsofluraneSevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Thomas Weber, PhD

    Ruhr University of Bochum, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Thomas Weber, Director Anesthesiology department St. Josef-Hospitital

Study Record Dates

First Submitted

September 24, 2018

First Posted

March 1, 2019

Study Start

December 10, 2014

Primary Completion

May 5, 2017

Study Completion

May 31, 2017

Last Updated

March 1, 2019

Record last verified: 2019-02