Different Volatile Anaesthetics and the Depth of Long Term ICU Sedation

Ruhr University of Bochum

Status: Completed

Conditions: Intensive Care Unit Syndrome

Treatments: Drug: Isoflurane; Drug: Desflurane; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT03860129

RUB 4780-13-B

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

ISO

Other group

Description:

Drug name: Isoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (0.5 Vol%)

Treatment:

Drug: Isoflurane

SEVO

Other group

Description:

Drug name: Sevoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (1.0 Vol%)

Treatment:

Drug: Sevoflurane

DES

Other group

Description:

Drug name: Desflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (3.0 Vol%)

Treatment:

Drug: Desflurane