Laparoscopic Bariatric Surgery: Impact of Deep Neuromuscular Block on Surgical Conditions
Information source: Central Hospital, Nancy, France
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bariatric Surgery; Laparoscopic Bariatric Surgery; Robotic Bariatric Surgery; Gastric Bypass; Morbid Obesity
Intervention: rocuronium (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Central Hospital, Nancy, France Official(s) and/or principal investigator(s): Thomas Fuchs-Buder, MD, Principal Investigator, Affiliation: CHU Nancy, Department of Anaesthesia & Critical Care
Overall contact: Thomas Fuchs-Buder, MD, Phone: #33.383.153942, Email: t.fuchs-buder@chu-nancy.fr
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.
Clinical Details
Official title: Laparoscopic Bariatric Surgery: Impact of the Level of Neuromuscular Blockade on Surgical Conditions - Comparison Between Moderate and Deep Neuromuscular Blockade
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Improvement of surgical conditions
Secondary outcome: Pneumoperitoneum generated pressure
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Thomas Fuchs-Buder, MD, Phone: #33.383.153942, Email: t.fuchs-buder@chu-nancy.fr
CHU Nancy/Brabois, Vandoeuvre-Les-Nancy F-54511, France; Recruiting Thomas Fuchs-Buder, MD, Phone: #33.383.153942, Email: t.fuchs-buder@chu-nancy.fr Thomas Fuchs-Buder, MD, Principal 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, Sub-Investigator
Additional Information
Starting date: July 2014
Last updated: July 29, 2015
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