Automated Control of End-tidal Volatile Anesthetic Concentration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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The new MIRUS system as well as the established AnaConDa system uses a reflector to conserve volatile anaesthetics (VA). Both systems act with commercially available ICU ventilators. In contrast to AnaConDa the MIRUS includes an automated control of end-tidal VA concentrations. In this study the investigators compared feasibility, costs and recovery times after anaesthesia with isoflurane (ISO), sevoflurane (SEVO) or desflurane (DES) in ventilated and spontaneously breathing patients.

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Detailed Description

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The study was approved by the appropriate Institutional Review Board. After written informed consent 63 ASA I-III patients undergoing elective hip or knee replacement surgery under general anesthesia were included. Patients were randomly organized into 3 groups (20-22 each). Anesthesia was induced with intravenous anaesthetics. After tracheal intubation MIRUS automatically adjusted the end-tidal VA concentration to 1.0 MAC. Patients were ventilated with the Puritan Bennett 840 ICU ventilator. After 1 h of anaesthesia with 1.0 MAC the ventilator mode was switched from SIMV V+ (totally controlled ventilation, "passive patient", with a tidal volume of 8 ml/IBW) to proportional assist ventilation (PAV) with 50% support ("active patient"). At the end of surgery the MIRUS system was stopped (MAC set to 0.0) and recovery times were measured.

Conditions

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Delayed Recovery From Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Desflurane

Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

Group A: Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Sevoflurane

Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Group B: Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Isoflurane

Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Group Type ACTIVE_COMPARATOR

Isoflurane

Intervention Type DRUG

Group C: Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Interventions

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Desflurane

Group A: Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Intervention Type DRUG

Sevoflurane

Group B: Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Intervention Type DRUG

Isoflurane

Group C: Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)

Intervention Type DRUG

Other Intervention Names

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Suprane Sevorane Forene

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No