Back to results

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

Primary Purpose

Bariatric Surgery, Laparoscopic Bariatric Surgery, Robotic Bariatric Surgery

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

rocuronium

About this trial

This is an interventional supportive care trial for Bariatric Surgery focused on measuring bariatric surgery, surgical conditions, deep neuromuscular blockade

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Nancy/BraboisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Moderate rocuronium neuromuscular blockade

deep rocuronium neuromuscular blockade

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pneumoperitoneum generated pressure

Concomitantly to the evaluation of the surgical conditions the pneumoperitoneal pressure (in mm Hg) generated by the Carbon dioxide insufflation will be registrated.

Full Information

NCT ID

NCT02118844

First Posted

April 15, 2014

Last Updated

July 29, 2015

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT02118844

Brief Title

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

Acronym

BaChiBloPro1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

bariatric surgery, surgical conditions, deep neuromuscular blockade

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Moderate rocuronium neuromuscular blockade

Arm Type

Active Comparator

Arm Description

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

Arm Title

deep rocuronium neuromuscular blockade

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

rocuronium

Primary Outcome Measure Information:

Title

Improvement of surgical conditions

Description

Time Frame

15 minutes

Secondary Outcome Measure Information:

Title

Pneumoperitoneum generated pressure

Description

Concomitantly to the evaluation of the surgical conditions the pneumoperitoneal pressure (in mm Hg) generated by the Carbon dioxide insufflation will be registrated.

Time Frame

15 minutes

Other Pre-specified Outcome Measures:

Title

time needed to perform gastrojejunal anastomosis

Description

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.

Time Frame

90 minutes

Title

10 point-VAS to evaluate surgical conditions

Description

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.

Time Frame

2 x 15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Fuchs-Buder, MD

Phone

#33.383.153942

t.fuchs-buder@chu-nancy.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Fuchs-Buder, MD

Organizational Affiliation

CHU Nancy, Department of Anaesthesia & Critical Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Nancy/Brabois

City

Vandoeuvre-Les-Nancy

ZIP/Postal Code

F-54511

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Fuchs-Buder, MD

Phone

#33.383.153942

t.fuchs-buder@chu-nancy.fr

First Name & Middle Initial & Last Name & Degree

Thomas Fuchs-Buder, MD

First Name & Middle Initial & Last Name & Degree

Claude Meistelman, MD

First Name & Middle Initial & Last Name & Degree

Laurent Brunaud, MD, PhD

First Name & Middle Initial & Last Name & Degree

Denis Schmartz, MD

First Name & Middle Initial & Last Name & Degree

Valérie Jacques, MD

First Name & Middle Initial & Last Name & Degree

Thibaut Fouquet, MD

First Name & Middle Initial & Last Name & Degree

Thomas Serradoni, MD

First Name & Middle Initial & Last Name & Degree

Claire Nominé, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

30985536

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs