Automated Control of End-tidal Volatile Anesthetic Concentration

Delayed Recovery From Anesthesia Clinical Trial

— MIRCONTROL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342509
• Other study ID #: RUB 4780-13
• Status: Completed
• Phase: N/A
• First received: January 6, 2015
• Last updated: January 14, 2015
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Delayed Recovery From Anesthesia

Intervention

Drug:
• Desflurane
Group A: Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
• Sevoflurane
Group B: Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
• Isoflurane
Group C: Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volatile anaesthetics (VA) consumption		duration of anesthesia: max. 3 h	Yes
Secondary	recovery times		duration post anesthesia care: max. 8 h after anesthesia	Yes