Different Volatile Anaesthetics and the Depth of Long Term ICU Sedation

February 28, 2019 updated by: Martin Bellgardt, Ruhr University of Bochum

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • Forene
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:
  • Sevorane
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:
  • Suprane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
usage of volatile anesthetics at 0.5 MAC during ICU Sedation
Time Frame: up to one week
Comparison between Isofluarne, Sevoflurane and Desflurane
up to one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Investigators

  • Principal Investigator: Thomas Weber, PhD, Ruhr-University of Bochum, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2014

Primary Completion (Actual)

May 5, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

September 24, 2018

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUB 4780-13-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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