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Finding the Right Dose of Sugammadex to Reverse Rocuronium Muscle Relaxation in Children Under 2 Years of Age During Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Surgical procedure preparation

    Your child will undergo a non-urgent surgical procedure that does not involve the heart, or a relative emergency procedure scheduled more than 12 hours in advance.

    The procedure will require the use of medications to temporarily relax muscles during surgery.

  2. Step 2

    Administration of rocuronium

    Your child will receive rocuronium, a medication that causes temporary muscle relaxation during the surgical procedure.

    This medication will be given through an injection or infusion into a vein.

    The dose will be determined by the medical team based on your child's weight and the requirements of the surgery.

    Additional doses may be given during the procedure if needed.

  3. Step 3

    Monitoring during surgery

    Throughout the procedure, the medical team will monitor the level of muscle relaxation using a device attached to your child's thumb.

    This monitoring uses a method called electromyographic monitoring, which measures the response of the thumb muscle to small electrical signals.

    The measurements are recorded as TOFc (a count from 0 to 4) and TOFr (a percentage), which indicate how relaxed the muscles are.

  4. Step 4

    Administration of sugammadex

    When the surgical procedure is complete, your child will receive sugammadex, a medication that reverses the muscle relaxation caused by rocuronium.

    The medication will be given through an injection into a vein.

    Your child will receive an initial dose of 0.2 mg per kilogram of body weight.

    The medical team will measure the muscle response approximately 3 minutes after each dose.

    If the muscle function has not fully returned (meaning the TOFr is not yet above 90%), your child will receive an additional dose of 0.2 mg per kilogram.

    This process will be repeated, with doses given approximately every 3 minutes, until complete muscle function is restored.

  5. Step 5

    Monitoring after sugammadex administration

    After each dose of sugammadex, the medical team will continue to monitor your child's muscle function using the same device on the thumb.

    The goal is to achieve complete reversal of muscle relaxation, defined as a TOFc of 4 out of 4 and a TOFr of 90% or higher.

    The medical team will check for any signs of muscle relaxation returning unexpectedly during this process.

    This would be identified by a decrease in the measurements taken from the thumb muscle.

  6. Step 6

    Extended monitoring period

    After your child achieves complete muscle function recovery, monitoring will continue for up to 60 minutes.

    During this time, the medical team will check to ensure that muscle relaxation does not return.

    This is done by continuing to measure the muscle response at regular intervals.

    The medical team will also observe your child for any breathing difficulties during the waking process or in the intensive care unit if applicable.

  7. Step 7

    Safety monitoring

    Throughout the entire process and after the procedure, the medical team will monitor your child for any adverse reactions related to the sugammadex medication.

    This includes watching for any return of muscle relaxation, breathing problems, or allergic reactions to the medication.

    Any such events will be recorded and managed appropriately by the medical team.

Who can join the trial?

8 criteria

  • Boys and girls younger than 24 months old
  • ASA Physical Status Class 1 or 2, which means the child is either healthy or has mild disease that does not limit daily activities
  • The child needs a surgery that is not urgent or is a relative emergency that can wait more than 12 hours, and the surgery is not on the heart
  • The surgery requires the use of rocuronium, a medicine that temporarily relaxes muscles during the operation, and sugammadex, a medicine that reverses the muscle relaxation after surgery
  • The surgery allows for monitoring of the adductor muscle of the thumb, which is a muscle in the hand that helps move the thumb
  • The child must be covered by a social security system
  • The parent or legal guardian must sign an informed consent form agreeing to the child's participation
  • The parent or legal guardian must speak French

Who cannot join the trial?

4 criteria

  • The study does not list specific exclusion criteria in the provided information. However, patients should discuss with their doctor whether they are suitable for this study, which involves testing a medication called sugammadex (a drug used to reverse muscle relaxation) in children under 24 months of age who receive rocuronium (a muscle relaxant used during surgery).
  • This study is only for children who need non-urgent surgery that is not related to the heart, or surgeries that can wait more than 12 hours.
  • The child must require the use of rocuronium for muscle relaxation during the surgical procedure.
  • Parents or guardians should inform the medical team about any existing health conditions, allergies, or medications the child is currently taking, as these factors may affect participation.
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Investigated drugs

  • Sugammadex

    is a medicine used to reverse the effects of muscle relaxation after surgery. During operations, doctors give patients medications to relax their muscles, and sugammadex helps the muscles return to normal function more quickly after the procedure is finished.

  • Rocuronium

    is a muscle relaxant medication given during surgery to temporarily paralyze muscles. This makes it easier for doctors to perform surgical procedures and helps with inserting breathing tubes. The effects of this medication need to be reversed after surgery so patients can breathe and move normally again.

What is already known about the treatment

  • Sugammadex

    Sugammadex is a medication given through injection into a vein that works to reverse muscle paralysis caused by certain drugs used during surgery. It is an approved medicine widely used in operating rooms to help patients regain their ability to breathe and move on their own after procedures requiring muscle relaxation. Sugammadex belongs to a class of drugs called selective relaxant binding agents, and it works by wrapping around and trapping rocuronium molecules in the bloodstream, quickly removing them from muscle receptors where they cause paralysis. This medication is primarily used at the end of surgical procedures to safely and rapidly restore normal muscle function, including breathing muscles.

  • Rocuronium

    Rocuronium is a muscle relaxant medication administered through an intravenous injection during surgical procedures to temporarily paralyze muscles, making it easier for surgeons to operate and for doctors to insert breathing tubes. It is a well-established drug used routinely in operating rooms worldwide as part of general anesthesia. Rocuronium belongs to a class of medications called neuromuscular blocking agents, and it works by blocking the signals between nerves and muscles at special connection points, preventing muscles from contracting. This medication is indicated for surgical procedures requiring muscle relaxation, and its effects can be reversed with specific reversal agents like sugammadex when the surgery is complete.

Investigated diseases

Neuromuscular Block – Neuromuscular block is a temporary condition where communication between nerves and muscles is interrupted, typically induced during surgery using specific medications. This state prevents muscle movement and is essential for certain surgical procedures requiring complete muscle relaxation. The condition is created by administering drugs called neuromuscular blocking agents, such as rocuronium, which prevent nerve signals from reaching muscles. During neuromuscular block, muscles cannot contract even when the brain sends signals for movement. The depth of the block can be measured and monitored throughout the procedure. The condition is reversed after surgery using special medications that restore normal nerve-muscle communication.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2025-521946-82-00Estimated enrolment99 patientsSponsorCentre Hospitalier Universitaire De Caen Normandie

sourced from the EU Clinical Trials Register and site verification

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