- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02545595
Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients
October 10, 2016 updated by: Poitiers University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Poitiers, France, 86021
- CHU de Poitiers
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sugammadex 1mg/kg
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
|
|
Experimental: Sugammadex 2mg/kg
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
|
|
Experimental: Sugammadex 4mg/kg
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare dosages based on ideal body weight to real body weight
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 27, 2013
First Submitted That Met QC Criteria
September 9, 2015
First Posted (Estimate)
September 10, 2015
Study Record Updates
Last Update Posted (Estimate)
October 12, 2016
Last Update Submitted That Met QC Criteria
October 10, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBRITI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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