Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial — SUGAPED-01  

Neuromuscular Blockade Clinical Trial

Official title: Reversal With Sugammadex (BRIDION ®) From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial of Efficacy and Safety

Status Completed

Clinical Trial 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.

Clinical Trial 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), and ventilatory problems (hypoxia, hypercapnia, atelectasis, airway collapse) that raise postoperative morbidity and mortality.

All of these facts are accentuated in the pediatric patient due to the reduced airway caliber which tends lead to obstruction and bronchospasm. So far, the effect of muscle relaxants has only been partially reversed by anticholinesterase (neostigmine), which has the limitation of its short duration of action (8-9 minutes) and has many side effects (bradycardia, hypotension, increased salivation, vomiting, dyspnea and bronchoconstriction). It also needs to be combined with anticholinergic (atropine), which causes a dry mouth, blurred vision and tachycardia.

At present, the introduction of sugammadex (Bridion®), an antagonist of nondepolarizing the neuromuscular relaxant rocuronium, may lead to an extraordinary breakthrough. It is the only antagonist able to encapsulate and fully eliminate the muscle relaxant to avoid residual effects and respiratory complications. Muscle strength can be retrieved at any time, without waiting for relaxant metabolism (30 to 40 minutes) and without using the usual classical antidotes (neostigmine and atropine), which produce many undesirable effects that become more troublesome in the postoperatory phase. Sugammadex lacks intrinsic activity and is considered safe, without significant side effects and can be used in cardiovascular or respiratory diseases. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade

• NCT number: NCT01809886
• Study type: Interventional
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Completion date: December 2013