Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 count (PTC) < of 2 induced and maintained with Rocuronium in pediatric patients for short-term elective surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Collaborators: Hospital Universitario Santa Maria del Rosell; Hospital Universitario Virgen de la Arrixaca
• Treatments: Neostigmine; Rocuronium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.