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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVA0 | Experimental | Propofol : TIVA guided by clinical signs. Remifentanil |
|
| TIVA BIS | Experimental | propofol : TIVA guided by EEG Monitoring. Remifentanil |
|
| TCI KBIS | Experimental | Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil. |
|
| TCI SBIS | Experimental | Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol : TCI Schnider | Drug | Target controlled infusion using schnider model for propofol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time spent at adequate BIS values | from the beginning to the end of the anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Constant, PhD | Hôpital Armand Trousseau | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement d'anesthesie Hopital Armand Trousseau | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D056805 | Consciousness Monitors |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
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| Propofol : TCI Kataria |
| Drug |
Target controlled infusion using Kataria model for propofol |
|
| Propofol : TIVA | Drug | Total intravenous anesthesia without use of a pharmokinetic model |
|
| EEG Monitoring | Device | Maintaining a bispectral index between 45 and 55 |
|
|
| Remifentanil | Drug | Remifentanil at discretion of the anesthesiologist |
|
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |