Status:

COMPLETED

Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients

Lead Sponsor:

University Hospital, Ghent

Conditions:

Morbidly Obese Patients

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission blocking agents, such...

Detailed Description

Flowchart : 72 participants Stratification BMI\<50 BMI \>50 Randomization Randomization TBW IBW TBW IBW 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 T...

Eligibility Criteria

Inclusion

  • Inclusion criteria :
  • ASA I-II-III
  • Age 18 - 65 year
  • Male or female
  • BMI \> 30
  • Exclusion criteria :
  • Renal failure
  • Liver dysfunction
  • Breastfeeding female patients, or female patients without reliable contraception
  • Neuromuscular disease
  • Malignant hyperthermia or a family history of malignant hyperthermia
  • Allergy for neuromuscular blocking agents or other medications used during general anesthesia
  • Infectious disease or patients with fever
  • Patients who already received rocuronium or sugammadex on the day of the study

Exclusion

    Key Trial Info

    Start Date :

    January 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2012

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT01911520

    Start Date

    January 1 2011

    End Date

    June 1 2012

    Last Update

    July 13 2021

    Active Locations (1)

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    1

    Ghent University Hospital

    Ghent, Belgium, 9000