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

NCT02118844 | Unknown Phase 4 DMC

• 1 other identifier: 2014-000289-23
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

bariatric surgery; surgical conditions; deep neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Pneumoperitoneum generated pressure

  15 minutes

Other Outcomes (2)

• time needed to perform gastrojejunal anastomosis

  90 minutes

• 10 point-VAS to evaluate surgical conditions

  2 x 15 minutes

Study Arms (2)

Moderate rocuronium neuromuscular blockade

ACTIVE COMPARATOR

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

Drug: rocuronium

deep rocuronium neuromuscular blockade

EXPERIMENTAL

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

Drug: rocuronium

Interventions

rocuronium DRUG

Moderate rocuronium neuromuscular blockade; deep rocuronium neuromuscular blockade

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• known hypersensibility to any of the drugs used during this study
• absence of written informed consent

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHU Nancy/Brabois

Vandœuvre-lès-Nancy, F-54511, France

RECRUITING

Related Publications (1)

• Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996.

  PMID: 30985536 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Thomas Fuchs-Buder, MD

  CHU Nancy, Department of Anaesthesia & Critical Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Fuchs-Buder, MD

CONTACT

#33.383.153942; t.fuchs-buder@chu-nancy.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 21, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 30, 2015

Record last verified: 2015-07

Locations

FR (1)