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Completed

NCT Number: NCT03860129

Different Volatile Anaesthetics and the Depth of Long Term ICU Sedation

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).

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Key information

Conditions

Intensive Care Unit Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isoflurane

Drug

Group A: Isoflurane (0.5 MAC)

Other names: Forene

Sevoflurane

Drug

Group B: Sevoflurane (0.5 MAC)

Other names: Sevorane

Desflurane

Drug

Group C: Desflurane (0.5 MAC)

Other names: Suprane

Primary outcomes

  1. usage of volatile anesthetics at 0.5 MAC during ICU Sedation

    Time frame: up to one week

    Comparison between Isofluarne, Sevoflurane and Desflurane

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2019
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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