Laparoscopic Bariatric Surgery: Impact of Deep Neuromuscular Block on Surgical Conditions

Morbid Obesity Clinical Trial

— BaChiBloPro1  

Official title:

Laparoscopic Bariatric Surgery: Impact of the Level of Neuromuscular Blockade on Surgical Conditions - Comparison Between Moderate and Deep Neuromuscular Blockade

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02118844
• Other study ID #: 2014-000289-23
• Status: Recruiting
• Phase: Phase 4
• First received: April 15, 2014
• Last updated: July 29, 2015
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: July 2015
• Source: Central Hospital, Nancy, France
• Contact: Thomas Fuchs-Buder, MD
• Phone: #33.383.153942
• Email: t.fuchs-buder[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: April 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bariatric Surgery
• Gastric Bypass
• Laparoscopic Bariatric Surgery
• Morbid Obesity
• Obesity, Morbid
• Robotic Bariatric Surgery

Intervention

Drug:
• rocuronium

Locations

Country	Name	City	State
France	CHU Nancy/Brabois	Vandoeuvre-Les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	10 point-VAS to evaluate surgical conditions	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	No
Primary	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	No
Secondary	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	No