Laparoscopic Bariatric Surgery: Impact of Deep Neuromuscular Block on Surgical Conditions (BaChiBloPro1)

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 4

Conditions: Gastric Bypass; Robotic Bariatric Surgery; Bariatric Surgery; Morbid Obesity; Laparoscopic Bariatric Surgery

Treatments: Drug: rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT02118844

2014-000289-23

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Moderate rocuronium neuromuscular blockade

Active Comparator group

Description:

rocuronium bolus is given if needed to maintain moderate neuromuscular blockade (TOF-count 2-4) during gastrojejunal anastomosis

Treatment:

Drug: rocuronium

deep rocuronium neuromuscular blockade

Experimental group

Description:

rocuronium bolus is given if needed to maintain deep neuromuscular blockade (here defined as a Posttetanic Count 1 - 5) during gastrojejunal anastomosis

Treatment:

Drug: rocuronium