Clinical trial NCT01809886: Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial
Official title: Reversal With Sugammadex (BRIDION ®) From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial of Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuromuscular Blockade
Keywords: Neuromuscular relaxants
short-term pediatric surgery
reverses neuromuscular blockade
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen de la Arrixaca
name: Hospital Universitario Santa Maria del Rosell
First posted: 2013-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: The time in seconds which has elapsed until a T4/T1 ratio >0,9.
timeFrame: After surgery (Up to 10 h)
Secondary outcomes:
measure: Heart Rate (beats / min)
timeFrame: After surgery (Up to 10 h)
measure: Systolic and Diastolic blood pressure (mm HG)
timeFrame: After surgery (up to 10 h)
measure: Arterial oxygen saturation (%)
timeFrame: After surgery (up to 10 h)
measure: Total dose of rocuronium (mg/kg)
timeFrame: After surgery (up to 10 h)
measure: Number of participants with at least One Adverse event (AE)
timeFrame: up to 24 h
measure: Time in seconds from the initial dose administered of rocuronium until the maximum block is achieved(Onset time)
timeFrame: During peri-anesthetic period (up to 10 h)
measure: The time in seconds which has elapsed until a T4/T1 >0,8 is achieved.
timeFrame: After surgery (up to 10 h)
measure: The time in seconds which has elapsed until a T4/T1 ratio >0,7
timeFrame: After surgery (up to 10 h)
Other outcomes:
Locations:
city: El Palmar
country: Spain
facility: Mª Dolores Cárceles Barón
state: Murcia
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: MºDolores Cárceles Barón, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: