Different Volatile Anaesthetics and the Depth of Long Term ICU Sedation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intensive Care Unit Syndrome

Intervention / Treatment
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* Drug: Isoflurane
* Drug: Sevoflurane
* Drug: Desflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ISO<br>Drug name: Isoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (0.5 Vol%) | Drug: Isoflurane<br>* Group A: Isoflurane (0.5 MAC)<br>* Other names: Forene;|
| Other: SEVO<br>Drug name: Sevoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (1.0 Vol%) | Drug: Sevoflurane<br>* Group B: Sevoflurane (0.5 MAC)<br>* Other names: Sevorane;|
| Other: DES<br>Drug name: Desflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (3.0 Vol%) | Drug: Desflurane<br>* Group C: Desflurane (0.5 MAC)<br>* Other names: Suprane;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inhalational Sedation