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A plain-language summary of the goals, design and what participants do
This clinical trial is focused on children who are scheduled to undergo planned surgeries with general anesthesia. The study involves two medications: sugammadex and rocuronium bromide. Sugammadex is a medication used to reverse the effects of muscle relaxants, while rocuronium bromide is a muscle relaxant used during surgery to help with intubation, which is the process of inserting a tube into the windpipe to assist with breathing.
The purpose of the study is to analyze how often sugammadex is used, with and without the help of a device called the TetraGraph system. This system helps monitor the level of muscle relaxation during surgery. The study will observe children aged between 2 and 16 years who are receiving general anesthesia and a non-depolarizing muscle relaxant, like rocuronium bromide. The trial will compare the use of sugammadex in different scenarios to understand its effectiveness and safety.
Throughout the study, researchers will look at various factors, such as the time it takes to remove the breathing tube after surgery, any breathing problems that occur, and the overall quality of recovery. They will also assess the reliability of using the TetraGraph system in children and monitor for any side effects from the medications or the monitoring system. The study aims to provide valuable insights into the best practices for using these medications and monitoring systems in pediatric anesthesia.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
5 criteria
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Sugammadex is a medication used to help patients recover from the effects of certain muscle relaxants that are often used during surgery. When you undergo surgery, doctors may use muscle relaxants to make sure your muscles are completely relaxed. After the surgery, it's important to reverse these effects so you can move and breathe normally again. Sugammadex works by binding to the muscle relaxants in your body, helping to remove them and allowing your muscles to regain their normal function more quickly. In this study, the researchers are looking at how often sugammadex is used, especially when doctors use a special monitoring tool to check how well your muscles are working during and after surgery.
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