Study on the Use of Sugammadex and Rocuronium Bromide in Children Undergoing Surgery with General Anesthesia

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What is this study about?

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.

1 joining the study

Upon joining the study, informed consent must be obtained from both legally recognized representatives. This consent confirms understanding and agreement to participate in the study.

2 preparation for surgery

The study involves children aged over 2 years and up to 16 years who are scheduled for surgery under general anesthesia. This includes the use of a breathing tube, known as tracheal intubation, and a medication that temporarily relaxes muscles.

3 administration of medications

During the surgery, two medications are used: sugammadex and rocuronium bromide. Both are given through a vein, known as intravenous administration.

Rocuronium bromide is used to relax the muscles during surgery. The dosage and frequency are determined by the medical team based on individual needs.

Sugammadex is used to reverse the muscle relaxation effects of rocuronium bromide at the end of the surgery. The dosage is calculated based on body weight and the specific needs of the patient.

4 monitoring and evaluation

Throughout the procedure, the medical team monitors the effects of the medications using a system that measures muscle function. This helps determine the appropriate dosage of sugammadex needed to reverse muscle relaxation.

The primary goal is to analyze how often sugammadex is used with and without the aid of this monitoring system.

5 post-surgery care

After surgery, the time taken to remove the breathing tube is recorded. The medical team also observes for any breathing difficulties or other reactions.

The quality of awakening and any signs of confusion or agitation are assessed using a specific scale.

The effectiveness of the monitoring system in pediatric patients is evaluated by the medical team.

6 completion of study participation

Participation in the study concludes after the post-surgery observations and evaluations are completed. The study aims to finish by June 4, 2026.

Who Can Join the Study?

Children who are older than 2 years and up to 16 years old.
Children who will have surgery with general anesthesia. This means they will be put into a deep sleep so they do not feel pain during the surgery.
Children who will have a tube placed in their windpipe to help them breathe during surgery. This is called tracheal intubation.
Children who will receive a type of medicine called a non-depolarizing blockade agent. This medicine helps relax the muscles during surgery.
Both parents or legal guardians must understand and agree to the study by signing a consent form. This means they give permission for their child to participate in the study.

Who Cannot Join the Study?

Patients who are not scheduled to have planned surgical procedures with general anesthesia. General anesthesia is a type of medicine that makes you completely unconscious and unable to feel pain during surgery.
Patients who are not within the required age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are not part of a vulnerable population. A vulnerable population includes groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
IRCCS Istituto Giannina Gaslini	Genoa	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	03.06.2025

Trial locations

Investigated drugs:

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.

Residual Neuromuscular Paralysis – Residual neuromuscular paralysis occurs when muscle relaxants used during surgery do not fully wear off after the procedure. This condition can lead to weakened muscle function, particularly affecting the muscles involved in breathing. Patients may experience difficulty in breathing, swallowing, or maintaining an open airway. The condition is typically temporary but requires careful monitoring to ensure that muscle function returns to normal. It is often identified by a train-of-four ratio (TOFr) of less than 0.9, indicating incomplete recovery of neuromuscular function. Monitoring and management are crucial to prevent complications during the recovery phase.

Trial ID:

2024-517057-27-00

Protocol code:

MOTOR

NCT ID:

NCT06331611

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Use of Sugammadex and Rocuronium Bromide in Children Undergoing Surgery with General Anesthesia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?