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

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ClinicalTrials.gov Identifier: NCT01809886
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : March 6, 2014
Sponsor:
Collaborators:
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario Santa Maria del Rosell
Information provided by (Responsible Party):
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Sugammadex Drug: Neostigmine Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reversal With Sugammadex (BRIDION ®) From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial of Efficacy and Safety
Study Start Date : October 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sugammadex
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).
Drug: Sugammadex
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).

Active Comparator: Neostigmina
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).
Drug: Neostigmine
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).




Primary Outcome Measures :
  1. The time in seconds which has elapsed until a T4/T1 ratio >0,9. [ Time Frame: After surgery (Up to 10 h) ]

Secondary Outcome Measures :
  1. Heart Rate (beats / min) [ Time Frame: After surgery (Up to 10 h) ]
  2. Systolic and Diastolic blood pressure (mm HG) [ Time Frame: After surgery (up to 10 h) ]
  3. Arterial oxygen saturation (%) [ Time Frame: After surgery (up to 10 h) ]
  4. Total dose of rocuronium (mg/kg) [ Time Frame: After surgery (up to 10 h) ]
  5. Number of participants with at least One Adverse event (AE) [ Time Frame: up to 24 h ]
  6. Time in seconds from the initial dose administered of rocuronium until the maximum block is achieved(Onset time) [ Time Frame: During peri-anesthetic period (up to 10 h) ]
  7. The time in seconds which has elapsed until a T4/T1 >0,8 is achieved. [ Time Frame: After surgery (up to 10 h) ]
  8. The time in seconds which has elapsed until a T4/T1 ratio >0,7 [ Time Frame: After surgery (up to 10 h) ]


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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809886


Locations
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Spain
Mª Dolores Cárceles Barón
El Palmar, Murcia, Spain, 30120
Sponsors and Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario Santa Maria del Rosell
Investigators
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Principal Investigator: MºDolores Cárceles Barón, MD,PhD Hospital Universitario Virgen de la Arrixaca

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Responsible Party: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier: NCT01809886     History of Changes
Other Study ID Numbers: CT-PED-2010-01CT
2011-000401-50 ( EudraCT Number )
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014

Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:
Neuromuscular relaxants
short-term pediatric surgery
reverses neuromuscular blockade

Additional relevant MeSH terms:
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Rocuronium
Neostigmine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents