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

Phase 4

• Conditions: Bariatric Surgery; Laparoscopic Bariatric Surgery; Robotic Bariatric Surgery; Gastric Bypass; Morbid Obesity
• Interventions: Drug: rocuronium

• Registration Number: NCT02118844
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Study Start: 2014-07
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30
• Primary Completion: 2015-08
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Moderate rocuronium neuromuscular blockade	rocuronium	rocuronium bolus is given if needed to maintain moderate neuromuscular blockade (TOF-count 2-4) during gastrojejunal anastomosis
deep rocuronium neuromuscular blockade	rocuronium	rocuronium bolus is given if needed to maintain deep neuromuscular blockade (here defined as a Posttetanic Count 1 - 5) during gastrojejunal anastomosis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU Nancy/Brabois; 🇫🇷 Vandoeuvre-Les-Nancy, France