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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Sugammadex 1 mg/kg
Sugammadex 2 mg/kg
Sugammadex 4 mg/kg
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Morbid Obesity focused on measuring General anaesthesia, Curarization with rocuronium

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Poitiers

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sugammadex 1mg/kg

Sugammadex 2mg/kg

Sugammadex 4mg/kg

Arm Description

for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients

for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients

for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients

Outcomes

Primary Outcome Measures

determine a profound neuromuscular blockade reversal 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

Secondary Outcome Measures

Compare dosages based on ideal body weight to real body weight

Full Information

First Posted
March 27, 2013
Last Updated
October 10, 2016
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02545595
Brief Title
Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
General anaesthesia, Curarization with rocuronium

7. Study Design

Study Phase
Phase 2

8. Arms, Groups, and Interventions

Arm Title
Sugammadex 1mg/kg
Arm Type
Experimental
Arm Description
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
Arm Title
Sugammadex 2mg/kg
Arm Type
Experimental
Arm Description
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
Arm Title
Sugammadex 4mg/kg
Arm Type
Experimental
Arm Description
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
Intervention Type
Drug
Intervention Name(s)
Sugammadex 1 mg/kg
Intervention Type
Drug
Intervention Name(s)
Sugammadex 2 mg/kg
Intervention Type
Drug
Intervention Name(s)
Sugammadex 4 mg/kg
Primary Outcome Measure Information:
Title
determine a profound neuromuscular blockade reversal on ideal body weight
Description
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
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Compare dosages based on ideal body weight to real body weight
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

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

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