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Clinical Trials/NCT02118844
NCT02118844
Unknown
Phase 4

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

Central Hospital, Nancy, France1 site in 1 country92 target enrollmentJuly 2014

Overview

Phase
Phase 4
Intervention
rocuronium
Conditions
Bariatric Surgery
Sponsor
Central Hospital, Nancy, France
Enrollment
92
Locations
1
Primary Endpoint
Improvement of surgical conditions
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
April 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Moderate rocuronium neuromuscular blockade

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

Intervention: rocuronium

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

Intervention: rocuronium

Outcomes

Primary Outcomes

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 Outcomes

  • Pneumoperitoneum generated pressure(15 minutes)

Study Sites (1)

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