We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Minimum alveolar concentration of sevoflurane to maintain bispectral index below 50 in major vascular surgery
Secondary ID [1] 282882 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

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 0
Condition category
Condition code
Anaesthesiology 290023 290023 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287586 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290101 0
the bispectral index value after the exposure to a predetermined alveolar concentration of sevoflurane
Timepoint [1] 290101 0
10 minutes after reaching the predetermined end expiratory concentration of sevoflurane
Secondary outcome [1] 303948 0
Variation of blood pressure using invasive or non invasive monitoring as required and heart rate using ECG monitoring during exposure to sevoflurane
Timepoint [1] 303948 0
Every minute during the first 10 minutes of exposure to sevoflurane

Eligibility
Key inclusion criteria
ASA I or II adults scheduled to undergo major vascular surgery under general anaesthesia
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy to sevoflurane
Previous renal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Up and down design
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
We fixed the sample size according to the three previous studies that all used 20 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5249 0
Tunisia
State/province [1] 5249 0

Funding & Sponsors
Funding source category [1] 287688 0
Hospital
Name [1] 287688 0
Military Hospital of Tunis
Address [1] 287688 0
Montfleury
1089 Tunis
Country [1] 287688 0
Tunisia
Primary sponsor type
Hospital
Name
Military Hospital of Tunis
Address
Montfleury
1089 Tunis
Country
Tunisia
Secondary sponsor category [1] 286421 0
None
Name [1] 286421 0
Address [1] 286421 0
Country [1] 286421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289647 0
Military Hospital of Tunis Local Ethics Committee
Ethics committee address [1] 289647 0
Montfleury
1089 Tunis
Ethics committee country [1] 289647 0
Tunisia
Date submitted for ethics approval [1] 289647 0
Approval date [1] 289647 0
17/04/2013
Ethics approval number [1] 289647 0
043/013

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41650 0
Dr Radhouane Bousselmi
Address 41650 0
Military Hospital of Tunis
15 avenue de la Republique
2000 Bardo
Country 41650 0
Tunisia
Phone 41650 0
+216 22 622 495
Fax 41650 0
Email 41650 0
rdh.bousselmi@gmail.com
Contact person for public queries
Name 41651 0
Dr Radhouane Bousselmi
Address 41651 0
Military Hospital of Tunis
15 avenue de la Republique
2000 Bardo
Country 41651 0
Tunisia
Phone 41651 0
+216 22 622 495
Fax 41651 0
Email 41651 0
rdh.bousselmi@gmail.com
Contact person for scientific queries
Name 41652 0
Dr Radhouane Bousselmi
Address 41652 0
Military Hospital of Tunis
15 avenue de la Republique
2000 Bardo
Country 41652 0
Tunisia
Phone 41652 0
+216 22 622 495
Fax 41652 0
Email 41652 0
rdh.bousselmi@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary