Bispectral Index Under Propofol Anesthesia in Children : a Study Between TIVA and TCI

Study Overview
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Brief Summary
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In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion: titration of the infusion rate on clinical signs (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI SBIS). Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate BIS values (45-55), the bias and imprecision will be calculated.

Official Title
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Bispectral Index Under Propofol Anesthesia in Children : a Comparative Randomised Study Between TIVA and TCI

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Propofol : TCI Schnider
* Drug: Propofol : TCI Kataria
* Drug: Propofol : TIVA
* Device: EEG Monitoring
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: weighting more than 15 kg; American Society of Anesthesiologists physical status I or II scheduled for middle ear surgery Exclusion Criteria: cardiovascular, neurological, hepatic or renal impairment, if their body mass index was above 95th percentile or if they received any drug interfering with the central nervous system.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIVA0<br>Propofol : TIVA guided by clinical signs. Remifentanil | Drug: Propofol : TIVA<br>* Total intravenous anesthesia without use of a pharmokinetic model<br>Drug: Remifentanil<br>* Remifentanil at discretion of the anesthesiologist<br>|
| Experimental: TIVA BIS<br>propofol : TIVA guided by EEG Monitoring. Remifentanil | Drug: Propofol : TIVA<br>* Total intravenous anesthesia without use of a pharmokinetic model<br>Device: EEG Monitoring<br>* Maintaining a bispectral index between 45 and 55<br>* Other names: BISPECTRAL INDEX;Drug: Remifentanil<br>* Remifentanil at discretion of the anesthesiologist<br>|
| Experimental: TCI KBIS<br>Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil. | Drug: Propofol : TCI Kataria<br>* Target controlled infusion using Kataria model for propofol<br>Device: EEG Monitoring<br>* Maintaining a bispectral index between 45 and 55<br>* Other names: BISPECTRAL INDEX;Drug: Remifentanil<br>* Remifentanil at discretion of the anesthesiologist<br>|
| Experimental: TCI SBIS<br>Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil. | Drug: Propofol : TCI Schnider<br>* Target controlled infusion using schnider model for propofol<br>Device: EEG Monitoring<br>* Maintaining a bispectral index between 45 and 55<br>* Other names: BISPECTRAL INDEX;Drug: Remifentanil<br>* Remifentanil at discretion of the anesthesiologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time spent at adequate BIS values |  | from the beginning to the end of the anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total intravenous anesthesia, Target Controlled Infusion, Propofol, Bispectral index, Children