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Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight?
The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). The research hypothesis is that both dosing regimens are equivalent
The secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very deep block (TOF count = 0 and PTC < 5)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| deep block ideal body weight | Experimental |
| |
| deep block real body weight | Active Comparator |
| |
| moderate block ideal body weight | Experimental |
| |
| moderate block real body weight | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ideal BW based sugammadex reversal of moderate block | Drug | 2 mg/kg sugammadex (based og ideal body weight) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 100% TOF-recovery 3 min after sugammadex | 3 min |
| Measure | Description | Time Frame |
|---|---|---|
| impact of depth of block on surgical conditions | to evaluate the impact of neuromuscular blockade on surgical conditions, the The "King Score" (King M, Anesthesiology 2000; 93:1392 - 7) will be applied every 15 min throught surgery by the surgeon (blinded to the study protocol)King-Score: from 1 to 4 with 1 excellent conditions, 2 good conditions, 3 acceptable conditions and 4 poor conditions. | every 15 min during surgery |
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Inclusion Criteria:
adult patients undergoing bariatric surgery according to the respective criteria of the French Medical Authority (HAS) and having given their written informed consent after appropriate information
Exclusion Criteria:
not fulfilling the inclusion criteria, known or suspected allergy to any of the drugs used in that study, absence of written informed consent,doubt of pregnancy in women of childbearing age, pregnancy and breast feeding
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Strasbourg Hôpital Civil | Strasbourg | Alsace | 67091 | France | ||
| CHU Nancy |
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| real body weight based sugammadex reversal of moderate block | Drug | 2 mg/kg sugammadex (based on real BW) |
|
| real body weight based sugammadex reversal of deep block | Drug | 4 mg/kg sugammadex (based on real BW) |
|
| ideal body weight based sugammadex reversal of deep block | Drug | 4 mg/kg sugammadex (based on ideal BW) |
|
| Vandœuvre-lès-Nancy |
| Lorraine |
| 54500 |
| France |