Efficacy and safety of reversal with Sugammadex (BRIDION®) from deep Neuromuscular Blockade induced by rocuronium in childre

• Conditions: euromuscular Blockade induced by Rocuronium; MedDRA version: 14.0Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-000401-50-ES
• Lead Sponsor: Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Children of both sexes, aged between two and eleven years will have surgery for procedures of short duration (less than one hour) and requiring muscle relaxation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Express their wish not to participate in the trial
- Patients with anticipated difficult airway
- Patients with Neuromuscular disease-present
-Liver failure and / or renal
-Have personal or family history of malignant hyperthermia,
-Submitted previous allergic reaction to any anesthetic.
-On treatment at the time of the study with aminoglycosides, magnesium, anticonvulsants, toremifene, Flucloxacillin and Fusidic Acid

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified