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(MOTOR Study) Neuromuscular MOniTOring in pediatric anesthesia. Randomized clinical study
EU CTIS ID: 2024-517057-27-00
What this study is testing
The main objective of the study is to analyze the frequency of sugammadex use, with and without the aid of quantitative neuromuscular monitoring.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.