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Trial record 5 of 6 for:    "PROFOUND" | France

Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients

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ClinicalTrials.gov Identifier: NCT02545595
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:
This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.

Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: Sugammadex 1 mg/kg Drug: Sugammadex 2 mg/kg Drug: Sugammadex 4 mg/kg Phase 2

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Study Type : Interventional  (Clinical Trial)
Study Start Date : May 2012
Actual Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Sugammadex 1mg/kg
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
Drug: Sugammadex 1 mg/kg
Experimental: Sugammadex 2mg/kg
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
Drug: Sugammadex 2 mg/kg
Experimental: Sugammadex 4mg/kg
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
Drug: Sugammadex 4 mg/kg



Primary Outcome Measures :
  1. determine a profound neuromuscular blockade reversal on ideal body weight [ Time Frame: 30 minutes ]
    A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success


Secondary Outcome Measures :
  1. Compare dosages based on ideal body weight to real body weight [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • General anaesthesia
  • Neuromuscular blockade induce by rocuronium
  • Body Masse Indice ≥ 40 kg/m2
  • informed consent

Exclusion Criteria:

  • Contraindication to rocuronium or sugammadex
  • Pregnant women
  • Severe renal insufficiency

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): NCT02545595


Locations
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France
CHU de Poitiers
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02545595    
Other Study ID Numbers: OBRITI
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Keywords provided by Poitiers University Hospital:
General anaesthesia
Curarization with rocuronium
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