search
Back to results

Automated Control of End-tidal Volatile Anesthetic Concentration (MIRCONTROL)

Primary Purpose

Delayed Recovery From Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Desflurane
Sevoflurane
Isoflurane
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Delayed Recovery From Anesthesia focused on measuring et Control, inhalational sedation, conserve volatile anesthetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Desflurane

    Sevoflurane

    Isoflurane

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    volatile anaesthetics (VA) consumption

    Secondary Outcome Measures

    recovery times

    Full Information

    First Posted
    January 6, 2015
    Last Updated
    January 14, 2015
    Sponsor
    Ruhr University of Bochum
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02342509
    Brief Title
    Automated Control of End-tidal Volatile Anesthetic Concentration
    Acronym
    MIRCONTROL
    Official Title
    Automated Control of End-tidal Volatile Anesthetic Concentration Using the MIRUS System: A Comparison of Isoflurane, Sevoflurane and Desflurane in Anesthesia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ruhr University of Bochum

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    The study was approved by the appropriate Institutional Review Board. After written informed consent 63 ASA I-III patients undergoing elective hip or knee replacement surgery under general anesthesia were included. Patients were randomly organized into 3 groups (20-22 each). Anesthesia was induced with intravenous anaesthetics. After tracheal intubation MIRUS automatically adjusted the end-tidal VA concentration to 1.0 MAC. Patients were ventilated with the Puritan Bennett 840 ICU ventilator. After 1 h of anaesthesia with 1.0 MAC the ventilator mode was switched from SIMV V+ (totally controlled ventilation, "passive patient", with a tidal volume of 8 ml/IBW) to proportional assist ventilation (PAV) with 50% support ("active patient"). At the end of surgery the MIRUS system was stopped (MAC set to 0.0) and recovery times were measured.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delayed Recovery From Anesthesia
    Keywords
    et Control, inhalational sedation, conserve volatile anesthetics

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Desflurane
    Arm Type
    Experimental
    Arm Description
    Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
    Arm Title
    Sevoflurane
    Arm Type
    Experimental
    Arm Description
    Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
    Arm Title
    Isoflurane
    Arm Type
    Active Comparator
    Arm Description
    Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
    Intervention Type
    Drug
    Intervention Name(s)
    Desflurane
    Other Intervention Name(s)
    Suprane
    Intervention Description
    Group A: Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Other Intervention Name(s)
    Sevorane
    Intervention Description
    Group B: Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
    Intervention Type
    Drug
    Intervention Name(s)
    Isoflurane
    Other Intervention Name(s)
    Forene
    Intervention Description
    Group C: Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
    Primary Outcome Measure Information:
    Title
    volatile anaesthetics (VA) consumption
    Time Frame
    duration of anesthesia: max. 3 h
    Secondary Outcome Measure Information:
    Title
    recovery times
    Time Frame
    duration post anesthesia care: max. 8 h after anesthesia

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signing of the informed consent document (patient or relatives). Patient age 18 years or older. ASA I-III Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Weber, PhD
    Organizational Affiliation
    Ruhr-Universtiy of Bochum, Germany
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25040673
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12594136
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Automated Control of End-tidal Volatile Anesthetic Concentration

    We'll reach out to this number within 24 hrs