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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
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
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

Study type
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

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

Key inclusion criteria
- ASA class 1 or 2.
- Proposed for elective surgery.
Minimum age
18 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Predicted difficult intubation.
- Hard-to-control hypertension.
- Coronaropathy.

Study design
Purpose of the study
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 6015 0
State/province [1] 6015 0

Funding & Sponsors
Funding source category [1] 289110 0
Name [1] 289110 0
Hopital Militaire Principal d'Instruction de Tunis
Address [1] 289110 0
Montfleury – 1008 Tunis
Country [1] 289110 0
Primary sponsor type
Hopital Militaire Principal d'Instruction de Tunis
Montfleury – 1008 Tunis
Secondary sponsor category [1] 287776 0
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
Montfleury - 1008 Tunis
Ethics committee country [1] 290904 0
Date submitted for ethics approval [1] 290904 0
Approval date [1] 290904 0
Ethics approval number [1] 290904 0

Brief summary
Bispectral index is a device used to monitor depth of anesthesia. Studies showed that it was well correlated with hypnotics, especially when used alone. Some data suggest that it can detect lack of analgesia. Our primary purpose was to test the ability of bispectral index to detect and/or predict the quality of analgesia.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 44386 0
Dr Abderrahmen Bargaoui
Address 44386 0
Hopital Militaire de Tunis. Montfleury 1008 Tunis
Country 44386 0
Phone 44386 0
Fax 44386 0
Email 44386 0
Contact person for public queries
Name 44387 0
Mr Abderrahmen Bargaoui
Address 44387 0
Hopital Militaire de Tunis. Montfleury 1008 Tunis
Country 44387 0
Phone 44387 0
Fax 44387 0
Email 44387 0
Contact person for scientific queries
Name 44388 0
Dr Abderrahmen Bargaoui
Address 44388 0
Hopital Militaire de Tunis. Montfleury 1008 Tunis
Country 44388 0
Phone 44388 0
Fax 44388 0
Email 44388 0

No information has been provided regarding IPD availability
Summary results
No Results