NCT02342509

Brief Summary

The new MIRUS system as well as the established AnaConDa system uses a reflector to conserve volatile anaesthetics (VA). Both systems act with commercially available ICU ventilators. In contrast to AnaConDa the MIRUS includes an automated control of end-tidal VA concentrations. In this study the investigators compared feasibility, costs and recovery times after anaesthesia with isoflurane (ISO), sevoflurane (SEVO) or desflurane (DES) in ventilated and spontaneously breathing patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 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

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

January 6, 2015

Last Update Submit

January 14, 2015

Conditions

Delayed Recovery From Anesthesia

Keywords

et Controlinhalational sedationconserve volatile anesthetics

Outcome Measures

Primary Outcomes (1)

  • volatile anaesthetics (VA) consumption

    duration of anesthesia: max. 3 h

Secondary Outcomes (1)

  • recovery times

    duration post anesthesia care: max. 8 h after anesthesia

Study Arms (3)

Desflurane

EXPERIMENTAL

Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Drug: Desflurane

Sevoflurane

EXPERIMENTAL

Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Drug: Sevoflurane

Isoflurane

ACTIVE COMPARATOR

Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Drug: Isoflurane

Interventions

DesfluraneDRUG

Group A: Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Also known as: Suprane
Desflurane
SevofluraneDRUG

Group B: Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Also known as: Sevorane
Sevoflurane
IsofluraneDRUG

Group C: Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Also known as: Forene
Isoflurane

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 (2)

  • 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

  • Meiser A, Sirtl C, Bellgardt M, Lohmann S, Garthoff A, Kaiser J, Hugler P, Laubenthal HJ. Desflurane compared with propofol for postoperative sedation in the intensive care unit. Br J Anaesth. 2003 Mar;90(3):273-80. doi: 10.1093/bja/aeg059.

    PMID: 12594136BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

DesfluraneSevofluraneIsoflurane

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Thomas Weber, PhD

    Ruhr-Universtiy 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
Dr. med.

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 21, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 21, 2015

Record last verified: 2015-01