Different Volatile Anaesthetics and the Depth of Long Term ICU Sedation
Study Details
Study Description
Brief Summary
The MIRUS system (TIM, Andernach, Germany) as well as the AnaConDa uses a reflector to conserve volatile anaesthetics (VA). Both systems can be paired with ICU ventilators, but MIRUS features an automated control of end-tidal VA concentrations (etVA). We compare depth of 0.5 MAC inhalational long-term sedation with Isoflurane (ISO), Sevoflurane (SEVO) or Desflurane (DES).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
The study was approved by the appropriate Institutional Review Board. Thirty ASA II-IV patients, undergoing elective or emergency surgery under general anaesthesia were included and randomized into three equal groups: ISO, SEVO or DES. We used MIRUS, a gas delivery system with a VA reflector, just like AnaConDa, that can be paired with common ICU ventilators. Additionally, MIRUS features the unique ability to maintain the end-tidal concentration (etVA) in target by automatically adjusting the delivery rate. Every 8 hours, the RASS was assessed by the nurse. The log of the EEG-Narcotrend Index (NI) was also included in the study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: ISO Drug name: Isoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (0.5 Vol%) |
Drug: Isoflurane
Group A: Isoflurane (0.5 MAC)
Other Names:
|
| Other: SEVO Drug name: Sevoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (1.0 Vol%) |
Drug: Sevoflurane
Group B: Sevoflurane (0.5 MAC)
Other Names:
|
| Other: DES Drug name: Desflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (3.0 Vol%) |
Drug: Desflurane
Group C: Desflurane (0.5 MAC)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- usage of volatile anesthetics at 0.5 MAC during ICU Sedation [up to one week]
Comparison between Isofluarne, Sevoflurane and Desflurane
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signing of the informed consent document (patient or relatives).
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Patient age 18 years or older.
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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-University of Bochum, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
- Bellgardt M, Drees D, Vinnikov V, Procopiuc L, Meiser A, Bomberg H, Gude P, Vogelsang H, Weber TP, Herzog-Niescery J. Use of the MIRUS™ system for general anaesthesia during surgery: a comparison of isoflurane, sevoflurane and desflurane. J Clin Monit Comput. 2018 Aug;32(4):623-627. doi: 10.1007/s10877-018-0138-z. Epub 2018 Apr 9.
- 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.
- Romagnoli S, Chelazzi C, Villa G, Zagli G, Benvenuti F, Mancinelli P, Arcangeli G, Dugheri S, Bonari A, Tofani L, Belardinelli A, De Gaudio AR. The New MIRUS System for Short-Term Sedation in Postsurgical ICU Patients. Crit Care Med. 2017 Sep;45(9):e925-e931. doi: 10.1097/CCM.0000000000002465.
- RUB 4780-13-B