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The purpose of this study is to determine whether deep neuromuscular blockade compared to moderate neuromuscular blockade may improve the surgical conditions in patients undergoing laparoscopic bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate rocuronium neuromuscular blockade | Active Comparator | rocuronium bolus is given if needed to maintain moderate neuromuscular blockade (TOF-count 2-4) during gastrojejunal anastomosis |
|
| deep rocuronium neuromuscular blockade | Experimental | rocuronium bolus is given if needed to maintain deep neuromuscular blockade (here defined as a Posttetanic Count 1 - 5) during gastrojejunal anastomosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rocuronium | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of surgical conditions | The surgical conditions will be evaluated with the King Score (M. King et al Anesthesiology 2000; 93: 1392 - 97). This score is a 4-point score. The evaluation will be done by the surgeon who is blinded. An improvement of at least 1-point will be considered as clinical relevant. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumoperitoneum generated pressure | Concomitantly to the evaluation of the surgical conditions the pneumoperitoneal pressure (in mm Hg) generated by the Carbon dioxide insufflation will be registrated. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| time needed to perform gastrojejunal anastomosis | The time from begin of the gastrojejunal anastomosis until the end will be measured in min. The surgeon indicate begin and end of the gastrojejunal anastomosis. | 90 minutes |
| 10 point-VAS to evaluate surgical conditions |
Inclusion Criteria:
Non-inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Fuchs-Buder, MD | Contact | #33.383.153942 | t.fuchs-buder@chu-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Fuchs-Buder, MD | CHU Nancy, Department of Anaesthesia & Critical Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nancy/Brabois | Recruiting | Vandœuvre-lès-Nancy | F-54511 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30985536 | Derived | Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Concomitantly the the evaluation by the King score, the surgical conditions will be also evaluated by a 10 point VAS (visual-analog scale).This evaluation will also be realized by the surgeon, still blinded to the study arm. |
| 2 x 15 minutes |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |