Intensive Care Unit SyndromeNCT03860129
Different Volatile Anaesthetics and the Depth of Long Term ICU Sedation
A study testing Isoflurane, Sevoflurane and Desflurane in people with Intensive Care Unit Syndrome, run by Ruhr University of Bochum.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- Isoflurane, Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2014to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing of the informed consent document (patient or relatives).
- Patient age 18 years or older.
- ASA I-III
Who cannot join
- 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
About this study
Official title: 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).
Read the 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.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- Isoflurane, Sevoflurane, Desflurane
- Keywords
- inhalational Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsofluraneDrug
Also called Forene
Group A: Isoflurane (0.5 MAC)
SevofluraneDrug
Also called Sevorane
Group B: Sevoflurane (0.5 MAC)
DesfluraneDrug
Also called Suprane
Group C: Desflurane (0.5 MAC)
| Study group | Role | What they receive |
|---|---|---|
| ISO | Other | Drug name: Isoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (0.5 Vol%) Receives: Drug: Isoflurane |
| SEVO | Other | Drug name: Sevoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (1.0 Vol%) Receives: Drug: Sevoflurane |
| DES | Other | Drug name: Desflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (3.0 Vol%) Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
usage of volatile anesthetics at 0.5 MAC during ICU Sedation
Comparison between Isofluarne, Sevoflurane and Desflurane
Measured: up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start10 Dec 2014
- Primary completion5 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Bellgardt, Ruhr University of Bochum
- Investigators
- Thomas Weber, PhD, Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860129
- Sponsor's protocol ID
- RUB 4780-13-B
- Status last verified
- Feb 2019
- First submitted
- 24 Sep 2018
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bomberg H, Glas M, Groesdonk VH, Bellgardt M, Schwarz J, Volk T, Meiser A. A novel device for target controlled administration and reflection of desflurane--the Mirus. Anaesthesia. 2014 Nov;69(11):1241-50. doi: 10.1111/anae.12798. Epub 2014 Jul 9.
PubMed 25040673Romagnoli S, Chelazzi C, Villa G, Zagli G, Benvenuti F, Mancinelli P, Arcangeli G, Dugheri S, Bonari A, Tofani L, Belardinelli A, De Gaudio AR. The New MIRUS System for Short-Term Sedation in Postsurgical ICU Patients. Crit Care Med. 2017 Sep;45(9):e925-e931. doi: 10.1097/CCM.0000000000002465.
PubMed 28441236Bellgardt M, Drees D, Vinnikov V, Procopiuc L, Meiser A, Bomberg H, Gude P, Vogelsang H, Weber TP, Herzog-Niescery J. Use of the MIRUS system for general anaesthesia during surgery: a comparison of isoflurane, sevoflurane and desflurane. J Clin Monit Comput. 2018 Aug;32(4):623-627. doi: 10.1007/s10877-018-0138-z. Epub 2018 Apr 9.
PubMed 29633099Georgevici AI, Kyprianou T, Herzog-Niescery J, Procopiuc L, Loganathan S, Weber TP, Bellgardt M. Negative drift of sedation depth in critically ill patients receiving constant minimum alveolar concentration of isoflurane, sevoflurane, or desflurane: a randomized controlled trial. Crit Care. 2021 Apr 13;25(1):141. doi: 10.1186/s13054-021-03556-y.
PubMed 33849618Bellgardt M, Georgevici AI, Klutzny M, Drees D, Meiser A, Gude P, Vogelsang H, Weber TP, Herzog-Niescery J. Use of MIRUS for MAC-driven application of isoflurane, sevoflurane, and desflurane in postoperative ICU patients: a randomized controlled trial. Ann Intensive Care. 2019 Oct 16;9(1):118. doi: 10.1186/s13613-019-0594-8.
PubMed 31620921
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depth of Long Term ICU Sedation Under 0,5 MAC Isoflurane, Sevoflurane or Desflurane Using MIRUS, an Automated Delivery System for Volatile Anaesthetics
- ClinicalTrials.gov ID
- NCT03860129
- Acronym / sponsor ID
- RUB 4780-13-B
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- inhalational Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 10 Dec 2014 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ISO | Other | Drug: IsofluraneDrug name: Isoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (0.5 Vol%) |
| SEVO | Other | Drug: SevofluraneDrug name: Sevoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (1.0 Vol%) |
| DES | Other | Drug: DesfluraneDrug name: Desflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (3.0 Vol%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signing of the informed consent document (patient or relatives).
- Patient age 18 years or older.
- ASA I-III
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsofluraneAlso: ForeneGroup A: Isoflurane (0.5 MAC) | Drug | ISO |
| SevofluraneAlso: SevoraneGroup B: Sevoflurane (0.5 MAC) | Drug | SEVO |
| DesfluraneAlso: SupraneGroup C: Desflurane (0.5 MAC) | Drug | DES |
Primary outcome
usage of volatile anesthetics at 0.5 MAC during ICU Sedation
Time frame: up to one week
Comparison between Isofluarne, Sevoflurane and Desflurane
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Background: PubMed 25040673Bomberg H, Glas M, Groesdonk VH, Bellgardt M, Schwarz J, Volk T, Meiser A. A novel device for target controlled administration and reflection of desflurane--the Mirus. Anaesthesia. 2014 Nov;69(11):1241-50. doi: 10.1111/anae.12798. Epub 2014 Jul 9.
- Background: PubMed 28441236Romagnoli S, Chelazzi C, Villa G, Zagli G, Benvenuti F, Mancinelli P, Arcangeli G, Dugheri S, Bonari A, Tofani L, Belardinelli A, De Gaudio AR. The New MIRUS System for Short-Term Sedation in Postsurgical ICU Patients. Crit Care Med. 2017 Sep;45(9):e925-e931. doi: 10.1097/CCM.0000000000002465.
- Background: PubMed 29633099Bellgardt M, Drees D, Vinnikov V, Procopiuc L, Meiser A, Bomberg H, Gude P, Vogelsang H, Weber TP, Herzog-Niescery J. Use of the MIRUS system for general anaesthesia during surgery: a comparison of isoflurane, sevoflurane and desflurane. J Clin Monit Comput. 2018 Aug;32(4):623-627. doi: 10.1007/s10877-018-0138-z. Epub 2018 Apr 9.
- Derived from this study: PubMed 33849618Georgevici AI, Kyprianou T, Herzog-Niescery J, Procopiuc L, Loganathan S, Weber TP, Bellgardt M. Negative drift of sedation depth in critically ill patients receiving constant minimum alveolar concentration of isoflurane, sevoflurane, or desflurane: a randomized controlled trial. Crit Care. 2021 Apr 13;25(1):141. doi: 10.1186/s13054-021-03556-y.
- Derived from this study: PubMed 31620921Bellgardt M, Georgevici AI, Klutzny M, Drees D, Meiser A, Gude P, Vogelsang H, Weber TP, Herzog-Niescery J. Use of MIRUS for MAC-driven application of isoflurane, sevoflurane, and desflurane in postoperative ICU patients: a randomized controlled trial. Ann Intensive Care. 2019 Oct 16;9(1):118. doi: 10.1186/s13613-019-0594-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Weber, PhD principal investigator
Ruhr University of Bochum
Questions about this trial
What is this clinical trial studying?
A study testing Isoflurane, Sevoflurane and Desflurane in people with Intensive Care Unit Syndrome, run by Ruhr University of Bochum.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
usage of volatile anesthetics at 0.5 MAC during ICU Sedation (time frame: up to one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860129, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.