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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02118844
Recruitment Status : Unknown
Verified July 2015 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : April 21, 2014
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment Phase
Bariatric Surgery Laparoscopic Bariatric Surgery Robotic Bariatric Surgery Gastric Bypass Morbid Obesity Drug: rocuronium Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Laparoscopic Bariatric Surgery: Impact of the Level of Neuromuscular Blockade on Surgical Conditions - Comparison Between Moderate and Deep Neuromuscular Blockade
Study Start Date : July 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118844


Contacts
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Contact: Thomas Fuchs-Buder, MD #33.383.153942 t.fuchs-buder@chu-nancy.fr

Locations
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France
CHU Nancy/Brabois Recruiting
Vandoeuvre-Les-Nancy, France, F-54511
Contact: Thomas Fuchs-Buder, MD    #33.383.153942    t.fuchs-buder@chu-nancy.fr   
Principal Investigator: Thomas Fuchs-Buder, MD         
Sub-Investigator: Claude Meistelman, 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         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Thomas Fuchs-Buder, MD CHU Nancy, Department of Anaesthesia & Critical Care

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02118844    
Other Study ID Numbers: 2014-000289-23
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Keywords provided by Central Hospital, Nancy, France:
bariatric surgery
surgical conditions
deep neuromuscular blockade
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs