This study is looking at children under 2 years of age who need surgery that is not urgent and does not involve the heart. During these operations, doctors use a medicine called rocuronium to temporarily relax the muscles, which helps the surgeon work safely. After the surgery is finished, another medicine called sugammadex is given to reverse the muscle relaxation so the child can breathe and move normally again. The study will test different amounts of sugammadex to find out how much is needed in very young children to completely reverse the effects of rocuronium.
The purpose of the study is to compare the dose of sugammadex that works in adults with the dose needed in children under 24 months of age. Doctors will measure muscle function using a special monitoring device that checks how well the muscles are working. They will give small repeated doses of sugammadex, each dose being 0.2 milligrams per kilogram of body weight, until the muscle function returns to normal. This is different from the usual practice where doctors give one single larger dose.
During the study, doctors will carefully watch how the child’s muscles respond after each dose of sugammadex is given. They will record the total amount of medicine needed to achieve complete muscle recovery and check whether the dose is lower or higher than what is typically used in adults. The medical team will also monitor for any problems such as the muscle relaxation coming back after it was reversed, any breathing difficulties, or allergic reactions to the medicine. The study will track these measurements for up to 60 minutes after the last dose of sugammadex is given.



France