Laparoscopic Bariatric Surgery: Impact of Deep Neuromuscular Block on Surgical Conditions (BaChiBloPro1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02118844|
Recruitment Status : Unknown
Verified July 2015 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : April 21, 2014
Last Update Posted : July 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bariatric Surgery Laparoscopic Bariatric Surgery Robotic Bariatric Surgery Gastric Bypass Morbid Obesity||Drug: rocuronium||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Laparoscopic Bariatric Surgery: Impact of the Level of Neuromuscular Blockade on Surgical Conditions - Comparison Between Moderate and Deep Neuromuscular Blockade|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||April 2016|
Active Comparator: Moderate rocuronium neuromuscular blockade
rocuronium bolus is given if needed to maintain moderate neuromuscular blockade (TOF-count 2-4) during gastrojejunal anastomosis
Experimental: deep rocuronium neuromuscular blockade
rocuronium bolus is given if needed to maintain deep neuromuscular blockade (here defined as a Posttetanic Count 1 - 5) during gastrojejunal anastomosis
- Improvement of surgical conditions [ Time Frame: 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.
- Pneumoperitoneum generated pressure [ Time Frame: 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.
- time needed to perform gastrojejunal anastomosis [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118844
|Contact: Thomas Fuchs-Buder, MDemail@example.com|
|Vandoeuvre-Les-Nancy, France, F-54511|
|Contact: Thomas Fuchs-Buder, MD #33.383.153942 firstname.lastname@example.org|
|Principal Investigator: Thomas Fuchs-Buder, MD|
|Sub-Investigator: Claude Meistelman, MD|
|Sub-Investigator: Laurent Brunaud, MD, PhD|
|Sub-Investigator: Denis Schmartz, MD|
|Sub-Investigator: Valérie Jacques, MD|
|Sub-Investigator: Thibaut Fouquet, MD|
|Sub-Investigator: Thomas Serradoni, MD|
|Sub-Investigator: Claire Nominé, MD|
|Principal Investigator:||Thomas Fuchs-Buder, MD||CHU Nancy, Department of Anaesthesia & Critical Care|