MIRCONTROL: Automated Control of End-tidal Volatile Anesthetic Concentration
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Desflurane Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95) |
Drug: Desflurane
Group A: Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
Other Names:
|
| Experimental: Sevoflurane Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95) |
Drug: Sevoflurane
Group B: Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
Other Names:
|
| Active Comparator: Isoflurane Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95) |
Drug: Isoflurane
Group C: Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- volatile anaesthetics (VA) consumption [duration of anesthesia: max. 3 h]
Secondary Outcome Measures
- recovery times [duration post anesthesia care: max. 8 h after anesthesia]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signing of the informed consent document (patient or relatives).
-
Patient age 18 years or older.
-
ASA I-III
Exclusion Criteria:
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ASA IV patients
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Epidural or spinal analgesia
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Allergy or known hypersensitivity to any of the study drugs
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Patients with known or suspected genetic susceptibility to malignant hyperthermia
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Previous participation in this trial
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Participation in another clinical trial within 4 weeks prior to selection.
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Pregnant women
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ruhr University of Bochum
Investigators
- Principal Investigator: Thomas Weber, PhD, Ruhr-Universtiy of Bochum, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Meiser A, Sirtl C, Bellgardt M, Lohmann S, Garthoff A, Kaiser J, Hügler P, Laubenthal HJ. Desflurane compared with propofol for postoperative sedation in the intensive care unit. Br J Anaesth. 2003 Mar;90(3):273-80.
- RUB 4780-13