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

July 29, 2015 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Vandoeuvre-Les-Nancy, France, F-54511
        • Recruiting
        • CHU Nancy/Brabois
        • Sub-Investigator:
          • Claude Meistelman, MD
        • Contact:
        • Principal Investigator:
          • Thomas Fuchs-Buder, MD
        • Sub-Investigator:
          • Laurent Brunaud, MD, PhD
        • Sub-Investigator:
          • Denis Schmartz, MD
        • Sub-Investigator:
          • Valérie Jacques, MD
        • Sub-Investigator:
          • Thibaut Fouquet, MD
        • Sub-Investigator:
          • Thomas Serradoni, MD
        • Sub-Investigator:
          • Claire Nominé, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moderate rocuronium neuromuscular blockade
rocuronium bolus is given if needed to maintain moderate neuromuscular blockade (TOF-count 2-4) during gastrojejunal anastomosis
Drug: rocuronium
Experimental: 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
Drug: rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of surgical conditions
Time Frame: 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.
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumoperitoneum generated pressure
Time Frame: 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.
15 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
time needed to perform gastrojejunal anastomosis
Time Frame: 90 minutes
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
10 point-VAS to evaluate surgical conditions
Time Frame: 2 x 15 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Thomas Fuchs-Buder, MD, CHU Nancy, Department of Anaesthesia & Critical Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-000289-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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