Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial (SUGAPED-01)
Reversal With Sugammadex (BRIDION ®) From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial of Efficacy and Safety
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Murcia
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El Palmar, Murcia, Španělsko, 30120
- Mª Dolores Cárceles Barón
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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).
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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).
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Aktivní komparátor: 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).
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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).
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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The time in seconds which has elapsed until a T4/T1 ratio >0,9.
Časové okno: After surgery (Up to 10 h)
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After surgery (Up to 10 h)
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Heart Rate (beats / min)
Časové okno: After surgery (Up to 10 h)
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After surgery (Up to 10 h)
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Systolic and Diastolic blood pressure (mm HG)
Časové okno: After surgery (up to 10 h)
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After surgery (up to 10 h)
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Arterial oxygen saturation (%)
Časové okno: After surgery (up to 10 h)
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After surgery (up to 10 h)
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Total dose of rocuronium (mg/kg)
Časové okno: After surgery (up to 10 h)
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After surgery (up to 10 h)
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Number of participants with at least One Adverse event (AE)
Časové okno: up to 24 h
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up to 24 h
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Time in seconds from the initial dose administered of rocuronium until the maximum block is achieved(Onset time)
Časové okno: During peri-anesthetic period (up to 10 h)
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During peri-anesthetic period (up to 10 h)
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The time in seconds which has elapsed until a T4/T1 >0,8 is achieved.
Časové okno: After surgery (up to 10 h)
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After surgery (up to 10 h)
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The time in seconds which has elapsed until a T4/T1 ratio >0,7
Časové okno: After surgery (up to 10 h)
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After surgery (up to 10 h)
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: MºDolores Cárceles Barón, MD,PhD, Hospital Universitario Virgen de La Arrixaca
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CT-PED-2010-01CT
- 2011-000401-50 (Číslo EudraCT)
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