Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Recruiting NCT05558969 - The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex N/A
Completed NCT03168308 - Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients Phase 4
Not yet recruiting NCT03978780 - Erector Spinae Block vs. Placebo Block Study N/A
Completed NCT02892045 - Mindray Neuromuscular Transmission Transducer
Completed NCT02912039 - Electromyographic Assessment of the TetraGraph in Normal Volunteers
Completed NCT03427385 - Minimum Local Anesthetic Dose for Adductor Canal Block N/A
Completed NCT01450813 - The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy N/A
Completed NCT00535496 - Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698) Phase 3
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Not yet recruiting NCT05993390 - Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients N/A
Recruiting NCT04609410 - Bleeding in Laparoscopic Liver Surgery N/A
Terminated NCT03649672 - The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor N/A
Completed NCT05474638 - Comparison of Mechanomyographic 100 Versus 200 Hz 5 Second Tetanic Fade Ratios During Neuromuscular Block Recovery N/A
Completed NCT05687253 - Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery Phase 2
Completed NCT05120999 - Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring
Completed NCT03608436 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery Phase 4
Completed NCT03572413 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis. Phase 4
Recruiting NCT02930629 - Residual Block in Postoperative Anaesthetic Care Unit N/A
Completed NCT02932254 - Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex Phase 4
Completed NCT01828385 - Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex Phase 4