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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

Tracking Information
First Submitted Date  ICMJE August 28, 2012
First Posted Date  ICMJE March 13, 2013
Last Update Posted Date March 6, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
The time in seconds which has elapsed until a T4/T1 ratio >0,9. [ Time Frame: After surgery (Up to 10 h) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01809886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
  • Heart Rate (beats / min) [ Time Frame: After surgery (Up to 10 h) ]
  • Systolic and Diastolic blood pressure (mm HG) [ Time Frame: After surgery (up to 10 h) ]
  • Arterial oxygen saturation (%) [ Time Frame: After surgery (up to 10 h) ]
  • Total dose of rocuronium (mg/kg) [ Time Frame: After surgery (up to 10 h) ]
  • Number of participants with at least One Adverse event (AE) [ Time Frame: up to 24 h ]
  • 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) ]
  • The time in seconds which has elapsed until a T4/T1 >0,8 is achieved. [ Time Frame: After surgery (up to 10 h) ]
  • The time in seconds which has elapsed until a T4/T1 ratio >0,7 [ Time Frame: After surgery (up to 10 h) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial
Official Title  ICMJE Reversal With Sugammadex (BRIDION ®) From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial of Efficacy and Safety
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuromuscular Blockade
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Sugammadex
  • 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).
    Intervention: Drug: Neostigmine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809886
Other Study ID Numbers  ICMJE CT-PED-2010-01CT
2011-000401-50 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study Sponsor  ICMJE Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators  ICMJE
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital Universitario Santa Maria del Rosell
Investigators  ICMJE
Principal Investigator: MºDolores Cárceles Barón, MD,PhD Hospital Universitario Virgen de la Arrixaca
PRS Account Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP