Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients
NCT ID: NCT01911520
Last Updated: 2021-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2011-01-31
2012-06-30
Brief Summary
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Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It allows for reversing of neuromuscular transmission blocking activity. Until now, all studies with sugammadex were performed in non-obese patients.
Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore it is vital to avoid residual curarization. Sugammadex might be an important factor.
Obese patients have a large total body weight different from ideal body weight. Recent research demonstrated that the dose for the neuromuscular blocking agent rocuronium (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total Body Weight.
At this moment no data is available on the dose-response relationship of sugammadex in morbidly obese patients.
We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal bodyweight, instead of total bodyweight.
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Detailed Description
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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
TBW : Total Body Weight IBW : Ideal Body Weight
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BMI < 50, Total Body Weight (TBW), 2mg/kg
Patients with a BMI \< 50, who will be dosed according to total body weight.
Sugammadex 2 mg/kg
Patients receive 2 mg/kg Sugammadex.
Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
BMI < 50, TBW, 4 mg/kg
Patients with a BMI \< 50, who will be dosed according to total body weight.
Sugammadex. 4 mg/kg
Patients receive 4 mg/kg Sugammadex.
Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
BMI < 50, Ideal Body Weight (IBW), 2 mg/kg
Patients with a BMI \< 50, who will be dosed according to ideal body weight.
Sugammadex 2 mg/kg
Patients receive 2 mg/kg Sugammadex.
Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
BMI < 50, IBW, 4 mg/kg
Patients with a BMI \< 50, who will be dosed according to ideal body weight.
Sugammadex. 4 mg/kg
Patients receive 4 mg/kg Sugammadex.
Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
BMI > 50, TBW, 2mg/kg
Patients with a BMI \> 50, who will be dosed according to total body weight.
Sugammadex 2 mg/kg
Patients receive 2 mg/kg Sugammadex.
Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
BMI > 50, TBW, 4mg/kg
Patients with a BMI \> 50, who will be dosed according to total body weight.
Sugammadex. 4 mg/kg
Patients receive 4 mg/kg Sugammadex.
Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
BMI >50, IBW, 2 mg/kg
Patients with a BMI \> 50, who will be dosed according to ideal body weight.
Sugammadex 2 mg/kg
Patients receive 2 mg/kg Sugammadex.
Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
BMI >50, IBW, 4 mg/kg
Patients with a BMI \> 50, who will be dosed according to ideal body weight.
Sugammadex. 4 mg/kg
Patients receive 4 mg/kg Sugammadex.
Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
Interventions
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Sugammadex 2 mg/kg
Patients receive 2 mg/kg Sugammadex.
Sugammadex. 4 mg/kg
Patients receive 4 mg/kg Sugammadex.
Neuromuscular monitoring.
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .
Every 30 min, during the first 2 hours after the end of the surgery.
Eligibility Criteria
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Inclusion Criteria
* Age 18 - 65 year
* Male or female
* BMI \> 30
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Jurgen Van Limmen, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Luc De Baerdemaeker, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Koen Reyntjens, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Related Links
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Related Info
Other Identifiers
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2009-016857-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2010/207
Identifier Type: -
Identifier Source: org_study_id
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