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Trial registered on ANZCTR


Registration number
ACTRN12614000487617
Ethics application status
Not yet submitted
Date submitted
23/04/2014
Date registered
9/05/2014
Date last updated
9/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Is bispectral index monitoring useful to assess the quality of analgesia in patients under general anesthesia?
Scientific title
Induction of general anesthesia and laryngoscopy with and without remifentanil: can bispectral index predict and/or detect the lack of analgesia?
Secondary ID [1] 284464 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General anesthesia 291690 0
Analgesia 291691 0
measuring depth of anesthesia 291693 0
Condition category
Condition code
Anaesthesiology 292073 292073 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Patients were randomized in 2 groups.
- Group P: induction of anesthesia performed by propofol alone.
- Group PR: induction of anesthesia performed by propofol and remifentanil.
- Propofol administration was performed in the 2 groups by target-controlled infusion (TCI) using Schnider model. We targeted a plasmatic concentration of 6ug/ml obtained over 2 minutes.
- Remifentanil administration was performed in the PR group by TCI using Minto model. We targeted a cerebral concentration of 4ng/ml.
- We noted the arterial pressure, heart rate and bispectral index (BIS) each minute.
- As BIS reached 60, consumption and cerebral concentration of propofol and time elapsed since the initiation of the induction were noted. Then, we fixed the plasmatic concentration of propofol to the cerebral concentration noted.
- A muscle relaxing agent was administered and a laryngoscopy with endotracheal intubation was performed.
- BIS, heart rate and arterial pressure were noted before and in the 2 minutes following laryngoscopy.
Intervention code [1] 289219 0
Treatment: Devices
Intervention code [2] 289300 0
Treatment: Drugs
Comparator / control treatment
Group P, where induction of anesthesia is performed by propofol alone.
Control group
Active

Outcomes
Primary outcome [1] 291949 0
Difference in DeltaBIS (maximum of BIS after laryngoscopy - BIS before laryngoscopy) between the P and the PR group.
Timepoint [1] 291949 0
2 minutes after laryngoscopy
Secondary outcome [1] 307906 0
Correlation between DeltaBIS and DeltaHeartRate. Heart rate is assessed by continuous electrocardiogram.
Timepoint [1] 307906 0
2 minutes after laryngoscopy
Secondary outcome [2] 307907 0
Correlation between DeltaBIS and DeltaArterialPressure. Arterial pressure is assessed by automated pneumatic cuff.
Timepoint [2] 307907 0
2 minutes after laryngoscopy

Eligibility
Key inclusion criteria
- ASA class 1 or 2.
- Proposed for elective surgery.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Predicted difficult intubation.
- Hard-to-control hypertension.
- Coronaropathy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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)
Simple randomisation by coin-tossing patient by patient
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
DeltaBIS, DeltaHeartRate and DeltaArterialPressure compared using t-student test.
Correlation measured by Pearson correlation coefficient.
The needed number of participants was calculated using the results of a previous study (Anesth Analg 1998;87:949-55). It was calculated on the basis of the primary outcome, with a power of 0,8 and an error risk of 0,05. We found a needed number of 28 in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6015 0
Tunisia
State/province [1] 6015 0
Tunis

Funding & Sponsors
Funding source category [1] 289110 0
Hospital
Name [1] 289110 0
Hopital Militaire Principal d'Instruction de Tunis
Country [1] 289110 0
Tunisia
Primary sponsor type
Hospital
Name
Hopital Militaire Principal d'Instruction de Tunis
Address
Montfleury – 1008 Tunis
Country
Tunisia
Secondary sponsor category [1] 287776 0
None
Name [1] 287776 0
Address [1] 287776 0
Country [1] 287776 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290904 0
Comité d'ethique local de l'Hopital Militaire de Tunis
Ethics committee address [1] 290904 0
Ethics committee country [1] 290904 0
Tunisia
Date submitted for ethics approval [1] 290904 0
25/04/2014
Approval date [1] 290904 0
Ethics approval number [1] 290904 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44386 0
Dr Abderrahmen Bargaoui
Address 44386 0
Hopital Militaire de Tunis. Montfleury 1008 Tunis
Country 44386 0
Tunisia
Phone 44386 0
+21622849078
Fax 44386 0
Email 44386 0
[email protected]
Contact person for public queries
Name 44387 0
Abderrahmen Bargaoui
Address 44387 0
Hopital Militaire de Tunis. Montfleury 1008 Tunis
Country 44387 0
Tunisia
Phone 44387 0
+21622849078
Fax 44387 0
Email 44387 0
[email protected]
Contact person for scientific queries
Name 44388 0
Abderrahmen Bargaoui
Address 44388 0
Hopital Militaire de Tunis. Montfleury 1008 Tunis
Country 44388 0
Tunisia
Phone 44388 0
+21622849078
Fax 44388 0
Email 44388 0
[email protected]

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
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Documents added automatically
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