Bariatric Surgery, Gastric Bypass, Laparoscopic Bariatric Surgery, Morbid Obesity, Robotic Bariatric Surgery
Conditions
Keywords
bariatric surgery, surgical conditions, deep neuromuscular blockade
Brief summary
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.
Interventions
DRUGrocuronium
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* patient between 18 and 64 years * indication for bariatric surgery accordingly to HAS * patient undergoing laparoscopic or robotic gastric bypass surgery * written informed consent * affiliation to social security Non-inclusion Criteria: * known hypersensibility to any of the drugs used during this study * absence of written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of surgical conditions | 15 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumoperitoneum generated pressure | 15 minutes | Concomitantly to the evaluation of the surgical conditions the pneumoperitoneal pressure (in mm Hg) generated by the Carbon dioxide insufflation will be registrated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| time needed to perform gastrojejunal anastomosis | 90 minutes | 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. |
| 10 point-VAS to evaluate surgical conditions | 2 x 15 minutes | 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. |
Countries
France
Contacts
Primary ContactThomas Fuchs-Buder, MD
Outcome results
None listed