Status:
COMPLETED
Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborating Sponsors:
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario Santa Maria del Rosell
Conditions:
Neuromuscular Blockade
Eligibility:
All Genders
2-11 years
Phase:
PHASE3
Brief Summary
The purpose of this clinical trial is to prove that the administration of sugammadex at a dose of 4 mg/kg for counteracting deep blockage \[without train-of-four (TOF) ratio response and post-tetanic ...
Detailed Description
Muscle relaxing facilitates endotracheal intubation and surgical access. Muscle relaxants have a long duration with the possibility of residual muscle relaxation after surgery (over 40% of patients), ...
Eligibility Criteria
Inclusion
- Children of both sexes,
- Aged between two and eleven years who have undergone surgery for procedures of short duration (less than one hour) and requiring muscle relaxation.
- Informed consent signed by parents or guardians
Exclusion
- No signed informed consent by parent/guardian,
- Anticipated difficult airway,
- Neuromuscular disease,
- Liver and/or renal failure,
- Personal or family history of malignant hyperthermia,
- Previous allergic reaction to any anesthetic.
- Treated at the time of the study with aminoglycosides, magnesium, or anticonvulsants.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01809886
Start Date
October 1 2011
End Date
December 1 2013
Last Update
March 6 2014
Active Locations (1)
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1
Mª Dolores Cárceles Barón
El Palmar, Murcia, Spain, 30120