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

Condition(s) targeted: Neuromuscular Blockade

Intervention: Sugammadex (Drug); Neostigmine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Official(s) and/or principal investigator(s):
MºDolores Cárceles Barón, MD,PhD, Principal Investigator, Affiliation: Hospital Universitario Virgen de la Arrixaca

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.

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

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

Primary outcome: The time in seconds which has elapsed until a T4/T1 ratio >0,9.

Secondary outcome:

Heart Rate (beats / min)

Systolic and Diastolic blood pressure (mm HG)

Arterial oxygen saturation (%)

Total dose of rocuronium (mg/kg)

Number of participants with at least One Adverse event (AE)

Time in seconds from the initial dose administered of rocuronium until the maximum block is achieved(Onset time)

The time in seconds which has elapsed until a T4/T1 >0,8 is achieved.

The time in seconds which has elapsed until a T4/T1 ratio >0,7

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.

Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.

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.

Mª Dolores Cárceles Barón, El Palmar, Murcia 30120, Spain

Starting date: October 2011
Last updated: March 5, 2014