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ISRCTN
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ISRCTN90609144
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ClinicalTrials.gov identifier
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Public title
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Inhalative long-term sedation with sevoflurane/remifentanil using the AnaConDa® system
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Scientific title
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Efficiency and safety of inhalative long-term sedation with sevoflurane/remifentanil compared to intravenous sedation with propofol/remifentanil in intensive care patients: a prospective randomised clinical trial
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Acronym
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Anaconda trial
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Serial number at source
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KKSH-044
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Study hypothesis
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Sedation with inhalative sedation using sevoflurane/remifentanil is more effective compared to intravenous sedation using propofol/remifentanil.
Please note that as of 06/02/09 this record was updated to include information on the ethics approval and the anticipated start date. The initial anticipated start date was 01/09/2008.
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Lay summary
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Ethics approval
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Added 06/02/2009: Ethics Board of the University Halle/Saale (Germany) gave approval in November 2008.
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Study design
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Prospective randomised clinical trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Sedation
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Participants - inclusion criteria
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1. Aged older than 18 years, either sex
2. Critically ill patients with mechanical ventilation
3. Need analgosedation for more than 48 hours
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Participants - exclusion criteria
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1. Pregnancy
2. Primary unfavourable prognosis
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Anticipated start date
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08/01/2009
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Anticipated end date
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01/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information
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Target number of participants
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100
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Interventions
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Sedation using the AnaConDa® system.
The study protocol implies a randomised prospective study with two groups including 50 patients in each group. Group S will be sedated with sevoflurane and remifentanil and Group P with propofol (disoprivan 2%) and remifentanil for day one to four. From the fifth day only the intravenous propofol is going to be switched to midazolam to avoid the danger of a propfol infusion syndrome. A rescue medication like esketamin or clonidin are allowed when indicated for example for shivering or insufficient sedation depth. There is also the possibility to exchange the remifentanil to sufentanil in both groups if the clinical situation demands it for example because of a persistent bradycardia during the analgosedation.
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Primary outcome measure(s)
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Weaning time (time end of sedation until spontaneous breathing)
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Secondary outcome measure(s)
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1. Sedation quality (daily assessment, Richmond Agitation Sedation scale, relation between aspired to real sedation depth, frequency of additional boli)
2. Flouride (daily measurement up to 3 days after stop sedation)
3. Cardiac markers (daily measurement up to 3 days after stop sedation)
4. Sedation depth (daily assessment, Richmond Agitation Aedation scale, BIS-Monitoring)
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Sources of funding
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Investigator initiated study, in parts funded by:
1. Sedana Medical (Sweden)
2. Draeger Medical Inc. (USA)
3. University Hospital Halle (Saale) (Germany)
4. Abbott Deutschland (Germany)
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Trial website
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Publications
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Contact name
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Dr
Jens
Soukup
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Address
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University Hospital Halle (Saale)
Department of Anaesthesiology and Critical Care
Ernst-Grube-Str. 40
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City/town
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Halle
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Zip/Postcode
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06120
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Country
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Germany
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Email
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jens.soukup@medizin.uni-halle.de
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Sponsor
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University Hospital Halle (Saale) (Germany)
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Address
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Department of Anaesthesiology and Critical Care
Ernst-Grube-Str. 40
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City/town
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Halle
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Zip/Postcode
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06120
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Country
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Germany
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Email
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jens.soukup@medizin.uni-halle.de
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Sponsor website:
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http://www.medizin.uni-halle.de/
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Date applied
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28/06/2008
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Last edited
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06/02/2009
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Date ISRCTN assigned
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31/07/2008
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