Different Volatile Anaesthetics and the Depth of Long Term ICU Sedation

Not Applicable

Completed

• Conditions: Intensive Care Unit Syndrome
• Interventions: Drug: Isoflurane; Drug: Sevoflurane; Drug: Desflurane

• Registration Number: NCT03860129
• Lead Sponsor: Ruhr University of Bochum

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).

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 Timeline

• Study Start: 2014-12-10
• Primary Completion: 2017-05-05
• Study Completion: 2017-05-31
• Study First Submitted: 2018-09-24
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-28
• Last Update Submitted: 2019-02-28
• Study First Posted: 2019-03-01
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ISO	Isoflurane	Drug name: Isoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (0.5 Vol%)
SEVO	Sevoflurane	Drug name: Sevoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (1.0 Vol%)
DES	Desflurane	Drug name: Desflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (3.0 Vol%)

Primary Outcome Measures

Name	Time	Method
usage of volatile anesthetics at 0.5 MAC during ICU Sedation	up to one week	Comparison between Isofluarne, Sevoflurane and Desflurane