(MOTOR Study) Neuromuscular MOniTOring in pediatric anesthesia. Randomized clinical study
- Conditions
- patients scheduled to undergo elective surgical procedures with general anesthesia
- Registration Number
- 2024-517057-27-00
- Lead Sponsor
- IRCCS Istituto Giannina Gaslini
- Brief Summary
The main objective of the study is to analyze the frequency of sugammadex use, with and without the aid of quantitative neuromuscular monitoring.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 200
Children > 2 years or ≤ 16 years
Children who will undergo surgery in general anesthesia with tracheal intubation and receiving a non-depolarizing blockade agent,
Acquisition of informed consent by both legally recognized representatives, capable of understanding the document and providing consent on behalf of the participant.
Children ≤ 2 years or > 16 years of age
Biliary tract and hepatic impairment, defined as levels of AST or ALT 3 times above the upper limit of the range of normality, or levels of total bilirubin 2 times above the upper limit of the range of normality, as reported by the local lab
Cardiac surgery
Emergency surgery
Known hypersensitivity to any of the study drugs or to any of their components, or to any component of the study drugs
Pregnancy or potential pregnancy
Any specific contraindication to any aspect of the protocol
Children with an ASA classification ≥ 3
Presence of neuromuscular disease, channelopathy, peripheral neuropathy or any clinical condition that could alter the neuromuscular function
Presence of contraindications to or impossible use of the TetraGraph monitoring: patients too small for the TetraSens Pediatric, skin lesions or tattoos in or in proximity of all the possible sites of the TetraSens Pediatric, implanted electronic device (such as a cardiac pacemaker), combined intraoperative use of short wave or microwave, epileptic patients, amputations or limb malformations.
Confirmed or suspected hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents or sugammadex
Conditions may affect the pharmacokinetics and/or pharmacodynamics of rocuronium bromide (biliary tract/hepatic/renal impairment, prolonged circulation time such as cardiovascular disease or edematous state, obesity, hypothermia, burn patients, severe electrolyte disturbances, altered blood pH or severe dehydration)
Confirmed or suspected contraindication to sugammadex (hypersensitivity to sugammadex or to any of the excipients)
Conditions may affect the pharmacokinetics and/or pharmacodynamics of sugammadex (increased risk of bleeding such as hereditary deficiencies of vitamin K-dependent coagulation factors, pre-existing coagulopathies. anticoagulants, renal and hepatic dysfunction, prolonged circulation time such as cardiovascular disease or edematous state, drugs such as Toremifene, EV fusidic acid, Hormonal contraceptives
Renal impairment, defined as GFR < 60 mL/min/1.73 m2, as calculated with Schwartz formula (eGFR = 0.5 × height (cm)/plasma creatinine)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint is the percentage of Sugammadex use in each arm at the end of anesthesia The primary endpoint is the percentage of Sugammadex use in each arm at the end of anesthesia
- Secondary Outcome Measures
Name Time Method The time needed to extubate patients The time needed to extubate patients
the difference in the dose of sugammadex (mg/kg) in the two arms 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 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 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 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) 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) 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 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 incidence of SpO2 < 90% in the post-operative acute care unit (PACU)
The frequency of sugammadex use in patients with TOFr ≥ 0.9 The frequency of sugammadex use in patients with TOFr ≥ 0.9
Trial Locations
- Locations (1)
IRCCS Istituto Giannina Gaslini
🇮🇹Genoa, Italy
IRCCS Istituto Giannina Gaslini🇮🇹Genoa, ItalyNicola DismaSite contact01056362445nicoladisma@gaslini.org