Clinical trial NCT02342509: Automated Control of End-tidal Volatile Anesthetic Concentration
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
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Recovery From Anesthesia
Keywords: et Control
inhalational sedation
conserve volatile anesthetics
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2015-01-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: volatile anaesthetics (VA) consumption
timeFrame: duration of anesthesia: max. 3 h
Secondary outcomes:
measure: recovery times
timeFrame: duration post anesthesia care: max. 8 h after anesthesia
Other outcomes:
Locations:
Study officials:
affiliation: Ruhr-Universtiy of Bochum, Germany
name: Thomas Weber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.