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Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia. |
|
| 2 | Experimental | Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| muscle relaxant | Drug | muscle relaxant administration throughout anesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| propofol dose | one hour anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| remifentanil dose | one hour anesthesia | |
| number of automatic modifications of the propofol and remifentanil concentrations | one hour anesthesia | |
| number of patients' movements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD | Hôpital Foch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Besançon | Besançon | 25000 | France | |||
| Institut Paoli-Calmette |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| normal saline |
| Drug |
no muscle relaxant throughout anesthesia (normal saline infused as a placebo) |
|
| one hour anesthesia |
| number of hemodynamic abnormalities requiring treatment | one hour anesthesia |
| time to wake up | end of anesthesia |
| intraoperative awareness | postoperative day 1 or 2 |
| performance of the closed-loop system | one hour anesthesia |
| Marseille |
| 13273 |
| France |
| Hôpital Foch | Suresnes | 92151 | France |