(MOTOR Study) Neuromuscular MOniTOring in pediatric anesthesia. Randomized clinical study

Conditions

patients scheduled to undergo elective surgical procedures with general anesthesia

Brief summary

The primary endpoint is the percentage of Sugammadex use in each arm at the end of anesthesia

Detailed description

The time needed to extubate patients, the difference in the dose of sugammadex (mg/kg) in the two arms, The frequency of respiratory complications during and after extubation (residual paralysis, upper airway obstruction, laryngospasm, bronchospasm), The best dose needed to reach the reversal of the neuromuscular blockade, indirectly evaluated from the need to administer further doses of sugammadex after extubation, Possible adverse reactions to the use of sugammadex or to the use of TetraGraph System, The incidence of extubation with residual neuromuscular paralysis (TOFr < 0.9), Quality of awakening and occurrence of any episodes of agitation/delirium (Richmond Agitation-Sedation Scale -RASS), The reliability of using quantitative neuromuscular monitoring in pediatrics, in the anesthetist's opinion, The incidence of SpO2 < 90% in the post-operative acute care unit (PACU), The frequency of sugammadex use in patients with TOFr ≥ 0.9

Related papers

No related papers found yet.

Interventions

DRUGSugammadex 100 mg/ml solution for injection

DRUGRocuronium bromide 10 mg/ml solution for injection/infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the percentage of Sugammadex use in each arm at the end of anesthesia	—

Secondary

Measure	Time frame
The time needed to extubate patients, the difference in the dose of sugammadex (mg/kg) in the two arms, The frequency of respiratory complications during and after extubation (residual paralysis, upper airway obstruction, laryngospasm, bronchospasm), The best dose needed to reach the reversal of the neuromuscular blockade, indirectly evaluated from the need to administer further doses of sugammadex after extubation, Possible adverse reactions to the use of sugammadex or to the use of TetraGraph System, The incidence of extubation with residual neuromuscular paralysis (TOFr < 0.9), Quality of awakening and occurrence of any episodes of agitation/delirium (Richmond Agitation-Sedation Scale -RASS), The reliability of using quantitative neuromuscular monitoring in pediatrics, in the anesthetist's opinion, The incidence of SpO2 < 90% in the post-operative acute care unit (PACU), The frequency of sugammadex use in patients with TOFr ≥ 0.9	—

Measure

Time frame

The time needed to extubate patients, the difference in the dose of sugammadex (mg/kg) in the two arms, The frequency of respiratory complications during and after extubation (residual paralysis, upper airway obstruction, laryngospasm, bronchospasm), The best dose needed to reach the reversal of the neuromuscular blockade, indirectly evaluated from the need to administer further doses of sugammadex after extubation, Possible adverse reactions to the use of sugammadex or to the use of TetraGraph System, The incidence of extubation with residual neuromuscular paralysis (TOFr < 0.9), Quality of awakening and occurrence of any episodes of agitation/delirium (Richmond Agitation-Sedation Scale -RASS), The reliability of using quantitative neuromuscular monitoring in pediatrics, in the anesthetist's opinion, The incidence of SpO2 < 90% in the post-operative acute care unit (PACU), The frequency of sugammadex use in patients with TOFr ≥ 0.9

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Countries

Italy

Outcome results

None listed