Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 3

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.
    

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), 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.
    

Intervention name(s): Sugammadex; Neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): 50 patients, aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with sugammadex 4 mg/kg when surgery is over, maintaining a profound block level until that point in time (no response to TOF and PTC<2).; 50 patients aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with neostigmine 0. 05 mg/kg and atropine 0.025 mg/kg (conventional reverser treatment) when surgery is over, maintaining a profound block level unit that point in time (no response to TOF and PTC<2).
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuromuscular relaxants; short-term pediatric surgery; reverses neuromuscular blockade