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Completed

NCT Number: NCT01809886

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

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.

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Key information

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mª Dolores Cárceles Barón

El Palmar, Murcia, 30120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugammadex

Drug

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).

Neostigmine

Drug

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 outcomes

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

    Time frame: After surgery (Up to 10 h)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Other

Collaborators

  • Hospital Universitario Santa Maria del Rosell
  • Hospital Universitario Virgen de la Arrixaca

Registry information

Official study title

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

Acronym: SUGAPED-01

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2013
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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