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

NCT ID: NCT02118844

Last Updated: 2015-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Moderate rocuronium neuromuscular blockade

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

Group Type ACTIVE_COMPARATOR

rocuronium

Intervention Type DRUG

deep rocuronium neuromuscular blockade

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

Group Type EXPERIMENTAL

rocuronium

Intervention Type DRUG

Interventions

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rocuronium

Intervention Type DRUG

Eligibility Criteria

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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


* known hypersensibility to any of the drugs used during this study
* absence of written informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Fuchs-Buder, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nancy, Department of Anaesthesia & Critical Care

Locations

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CHU Nancy/Brabois

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Thomas Fuchs-Buder, MD

Role: CONTACT

#33.383.153942

Facility Contacts

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Thomas Fuchs-Buder, MD

Role: primary

#33.383.153942

References

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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.

Reference Type DERIVED
PMID: 30985536 (View on PubMed)

Other Identifiers

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2014-000289-23

Identifier Type: -

Identifier Source: org_study_id

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