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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023943-13 | EudraCT Number |
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Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol-Remifentanil | Active Comparator | Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium |
|
| Sevoflurane-Remifentanil | Active Comparator | Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | sugammadex
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with an increase in Bispectral Index after sugammadex injection | Increase in Bispectral Index (> 20) after sugammadex injection | One hour after anesthesia |
| Number of patients with occurence of clinical signs of awakening after sugammadex injection | Clinical signs of awakening after sugammadex are wallowing, eye opening on demand, cough, spontaneous movements, response to simple commands, tearing, ... | One hour after anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| T4/T1 ratio after sugammadex injection | Modification of T4/T1 ratio after sugammadex injection | One hour after anesthesia |
| Number of patients with side effects due to sugammadex injection | Side effects after sugammadex injection are bradycardia, nausea or vomiting, pain, residual curarisation, awareness,... |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morgan Le Guen, MD | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Suresnes | Île-de-France Region | 92151 | France |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| One hour after anesthesia |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |