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Trial registered on ANZCTR
Registration number
ACTRN12613000846729
Ethics application status
Approved
Date submitted
25/07/2013
Date registered
1/08/2013
Date last updated
27/08/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Sevoflurane for maintenance of anaesthesia in major vascular surgery: using the bispectral index to determine the minimum alveolar concentration
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Scientific title
Minimum alveolar concentration of sevoflurane to maintain bispectral index below 50 in major vascular surgery
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Secondary ID [1]
282882
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
bispectral index guided minimum alveolar concentration of sevoflurane for maintenance of anaesthesia in major vascular surgery
289701
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Condition category
Condition code
Anaesthesiology
290023
290023
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
ASA physical status I and II patients scheduled to undergo major vascular surgery are enrolled in this study. Monitoring consists on blood pressure, heart rate, pulse oxymetry, endtidal CO2, entidal sevoflurane and bispectral index.
Induction of anaesthesia is standardized in all patients using target controlled infusion of propofol and remifentanil. Muscle relaxation is achieved with cisatracurium.
After tracheal intubation, propofol infusion is stopped. When the bispectral index reach 65 sevoflurane inhalation is started at the predetermined concentration. The predetermined endtidal concentration for the first patient is 2%. Sevoflurane is used once only to maintain anaesthesia.
The endtidal sevoflurane concentration is adjusted with starting dose of 2% for the first patient and maintained for 10 min to ensure equilibration with the cerebral anesthetic partial pressure followed by assessment of BIS. In the next patients doses are given according to the following rule: if the subject responds positively (BIS<50 after 10 minutes of sevoflurane), the endtidal concentration is decreased by 0.2% step for the next subject, and conversely, if the subject does not respond (BIS>50 after 10 minutes of sevoflurane), the dose is increased by 0.2% step.
The ED50 and ED95 of sevoflurane to maintain bispectral index below 50 are calculated using probit transformation.
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Intervention code [1]
287586
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Treatment: Drugs
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Comparator / control treatment
Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
290101
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the bispectral index value after the exposure to a predetermined alveolar concentration of sevoflurane
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Assessment method [1]
290101
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Timepoint [1]
290101
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10 minutes after reaching the predetermined end expiratory concentration of sevoflurane
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Secondary outcome [1]
303948
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Variation of blood pressure using invasive or non invasive monitoring as required and heart rate using ECG monitoring during exposure to sevoflurane
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Assessment method [1]
303948
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Timepoint [1]
303948
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Every minute during the first 10 minutes of exposure to sevoflurane
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Eligibility
Key inclusion criteria
ASA I or II adults scheduled to undergo major vascular surgery under general anaesthesia
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Known allergy to sevoflurane
Previous renal disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Up and down design
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Phase
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
We fixed the sample size according to the three previous studies that all used 20 participants.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
6/05/2013
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Actual
6/05/2013
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Date of last participant enrolment
Anticipated
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Actual
25/07/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5249
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Tunisia
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State/province [1]
5249
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Funding & Sponsors
Funding source category [1]
287688
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Hospital
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Name [1]
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Military Hospital of Tunis
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Address [1]
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Montfleury
1089 Tunis
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Country [1]
287688
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Tunisia
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Primary sponsor type
Hospital
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Name
Military Hospital of Tunis
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Address
Montfleury
1089 Tunis
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Country
Tunisia
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Secondary sponsor category [1]
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None
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Name [1]
286421
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Address [1]
286421
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Country [1]
286421
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289647
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Military Hospital of Tunis Local Ethics Committee
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Ethics committee address [1]
289647
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Montfleury
1089 Tunis
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Ethics committee country [1]
289647
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Tunisia
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Date submitted for ethics approval [1]
289647
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Approval date [1]
289647
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17/04/2013
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Ethics approval number [1]
289647
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043/013
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Summary
Brief summary
This study aim to determine the minimum alveolar concentration of sevoflurane to maintain the bispectral index below 50 in 95% of patients undergoing major vascular surgery. This will permit to better choose sevoflurane concentration that allow an adequate anaesthesia with a minimal risk of memorisation even when bispectral index is unavailable.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Radhouane Bousselmi
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Address
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Military Hospital of Tunis
15 avenue de la Republique
2000 Bardo
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Country
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Tunisia
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Phone
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+216 22 622 495
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
41651
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Dr Radhouane Bousselmi
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Address
41651
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Military Hospital of Tunis
15 avenue de la Republique
2000 Bardo
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Country
41651
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Tunisia
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Phone
41651
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+216 22 622 495
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Fax
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Email
41651
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[email protected]
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Contact person for scientific queries
Name
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Dr Radhouane Bousselmi
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Address
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Military Hospital of Tunis
15 avenue de la Republique
2000 Bardo
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Country
41652
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Tunisia
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Phone
41652
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+216 22 622 495
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Fax
41652
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Email
41652
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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