Different Volatile Anaesthetics and the Depth of Long Term ICU Sedation

Intensive Care Unit Syndrome Clinical Trial

Official title:

Depth of Long Term ICU Sedation Under 0,5 MAC Isoflurane, Sevoflurane or Desflurane Using MIRUS, an Automated Delivery System for Volatile Anaesthetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860129
• Other study ID #: RUB 4780-13-B
• Status: Completed
• Phase: N/A
• Start date: December 10, 2014
• Est. completion date: May 31, 2017

Study information

• Verified date: February 2019
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• 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

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome

Intervention

Drug:
• Isoflurane
Group A: Isoflurane (0.5 MAC)
• Sevoflurane
Group B: Sevoflurane (0.5 MAC)
• Desflurane
Group C: Desflurane (0.5 MAC)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

References & Publications (3)

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	usage of volatile anesthetics at 0.5 MAC during ICU Sedation	Comparison between Isofluarne, Sevoflurane and Desflurane	up to one week