SUGAMMADEX for Elective surgery requiring general anesthesia

Inclusion criteria

• {"criterion_text":"- Children > 2 years or ≤ 16 years"}
• {"criterion_text":"- Children who will undergo surgery in general anesthesia with tracheal intubation and receiving a non-depolarizing blockade agent,"}
• {"criterion_text":"- Acquisition of informed consent by both legally recognized representatives, capable of understanding the document and providing consent on behalf of the participant."}

Exclusion criteria

• {"criterion_text":"- Children ≤ 2 years or > 16 years of age"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Cardiac surgery"}
• {"criterion_text":"- Emergency surgery"}
• {"criterion_text":"- Known hypersensitivity to any of the study drugs or to any of their components, or to any component of the study drugs"}
• {"criterion_text":"- Pregnancy or potential pregnancy"}
• {"criterion_text":"- Any specific contraindication to any aspect of the protocol"}
• {"criterion_text":"- Children with an ASA classification ≥ 3"}
• {"criterion_text":"- Presence of neuromuscular disease, channelopathy, peripheral neuropathy or any clinical condition that could alter the neuromuscular function"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Confirmed or suspected hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents or sugammadex"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Confirmed or suspected contraindication to sugammadex (hypersensitivity to sugammadex or to any of the excipients)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Renal impairment, defined as GFR < 60 mL/min/1.73 m2, as calculated with Schwartz formula (eGFR = 0.5 × height (cm)/plasma creatinine)"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the percentage of Sugammadex use in each arm at the end of anesthesia","definition_or_measurement_approach":"Percentage of patients receiving sugammadex in each arm at the end of anesthesia"}

Secondary endpoints

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

Italy

Earliest CTIS Part Ii Submission Date

28-02-2025

Latest Decision Or Authorization Date

21-07-2025

Processing Time Days

143

Number Of Sites

1

Number Of Participants

200

Primary sponsor

Full Name

IRCCS Istituto Giannina Gaslini

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy