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NCT Number: NCT02342509

Automated Control of End-tidal Volatile Anesthetic Concentration

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.

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Key information

Conditions

Delayed Recovery From Anesthesia Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desflurane

Drug

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

Other names: Suprane

Sevoflurane

Drug

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

Other names: Sevorane

Isoflurane

Drug

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

Other names: Forene

Primary outcomes

  1. volatile anaesthetics (VA) consumption

    Time frame: duration of anesthesia: max. 3 h

Secondary outcomes

  1. recovery times

    Time frame: duration post anesthesia care: max. 8 h after anesthesia

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Automated Control of End-tidal Volatile Anesthetic Concentration Using the MIRUS System: A Comparison of Isoflurane, Sevoflurane and Desflurane in Anesthesia.

Acronym: MIRCONTROL

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 21, 2015
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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