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Study on Rocuronium Bromide for Neuromuscular Block in Infants with Craniosynostosis During Surgery

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Rocuronium bromide in infants undergoing surgery for a condition known as craniosynostosis. Craniosynostosis is a condition where the bones in a baby's skull join together too early, which can affect the shape of the head and brain development. The medication, Rocuronium bromide, is used to help relax muscles during surgery, making it easier for doctors to perform the procedure.

The purpose of the study is to understand how different doses of Rocuronium bromide work in infants, especially when used alongside two types of anesthesia: sevoflurane, which is inhaled, and propofol, which is given through an IV. Anesthesia is used to keep patients asleep and pain-free during surgery. The study aims to see how these anesthetics might change the way Rocuronium bromide works in the body, which could help doctors use the medication more safely and effectively in the future.

During the study, infants will receive different doses of Rocuronium bromide while undergoing surgery for craniosynostosis. Researchers will monitor how long the muscle relaxation lasts and how the medication interacts with the anesthesia. This information will help improve the safety and effectiveness of muscle relaxants in young patients. The study is designed to gather important data that could benefit future medical treatments for infants with similar conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves infants aged 3-12 months whose parents have provided written consent for participation.

    The study focuses on infants undergoing surgical treatment for craniosynostosis.

  2. Step 2

    Administration of medication

    The medication used in the study is rocuronium bromide, administered as a solution for injection or infusion.

    The medication is given intravenously, meaning it is injected directly into a vein.

  3. Step 3

    Monitoring during surgery

    The study measures the duration of the muscle relaxation effect caused by different doses of rocuronium.

    The effect of rocuronium is observed during the surgical procedure.

  4. Step 4

    Use of anesthesia

    Two types of anesthesia are used: sevoflurane for inhalational anesthesia and propofol for total intravenous anesthesia.

    The study investigates how these anesthetics affect the action of rocuronium.

  5. Step 5

    End of study participation

    The study aims to understand how the anesthetics influence the pharmacokinetic properties of rocuronium.

    The knowledge gained may help in safely reversing the muscle relaxant effects in infants.

Who can join the trial?

5 criteria

  • The study is looking for **20 infants** to participate.
  • The infants must be **between 3 to 12 months old**.
  • The parents of the infants must provide **informed written consent**. This means they agree to let their child participate after understanding the study details.
  • Both **male and female** infants can participate.
  • The study does not include any special or vulnerable groups.

Who cannot join the trial?

10 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who have any medical condition that might interfere with the study results.
  • Patients who are not able to give informed consent or understand the study procedures.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to the medications used in the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a significant medical condition that could affect their safety during the study.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a known sensitivity to **sevoflurane** or **propofol**, which are medications used for anesthesia.
  • Patients who have a known sensitivity to **rocuronium**, a medication used to relax muscles during surgery.
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Investigated drugs

  • Rocuronium

    is a medication used to relax muscles during surgery. In this trial, it is being studied to understand how long its effects last in infants undergoing surgery for craniosynostosis. The study aims to see how different doses of rocuronium work in this specific group of patients.

  • Sevoflurane

    is an inhaled anesthetic used to keep patients asleep during surgery. In this trial, it is being used to see how it affects the action of rocuronium when used together. The researchers want to know if sevoflurane changes how rocuronium works in infants.

  • Propofol

    is an intravenous anesthetic that helps keep patients asleep during surgery. This trial is examining how propofol might change the way rocuronium works when both are used together. The goal is to understand if propofol affects the duration of muscle relaxation caused by rocuronium in infants.

What is already known about the treatment

Rocuronium – Rocuronium is administered intravenously and is used to induce muscle relaxation during surgery. It is well-established in medical literature as a neuromuscular blocking agent. The main therapeutic indication for rocuronium is to facilitate tracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation. At the molecular level, rocuronium works by blocking the transmission of nerve impulses to the muscles, specifically by competing with acetylcholine for binding to receptors at the neuromuscular junction. It is classified pharmacologically as a non-depolarizing neuromuscular blocker.

Investigated diseases

  • Sevoflurane Inhalational Anesthesia

    Sevoflurane is a type of inhalational anesthesia used to maintain unconsciousness during surgery. It is administered through a mask or breathing circuit, allowing the patient to breathe in the anesthetic gas. The drug works by depressing the central nervous system, leading to a loss of consciousness and sensation. Its effects are generally rapid, allowing for quick adjustments in anesthesia depth. Sevoflurane is often chosen for its smooth induction and recovery profile. It is commonly used in both adult and pediatric anesthesia.

  • Propofol Total Intravenous Anesthesia

    Propofol is a medication used to induce and maintain anesthesia through intravenous administration. It acts quickly to produce a state of deep sedation or unconsciousness. The drug is known for its rapid onset and short duration of action, making it suitable for procedures requiring quick recovery. Propofol is often used in combination with other medications to enhance its effects. It is favored for its ability to provide a smooth and controlled anesthetic experience. The medication is widely used in various surgical and diagnostic procedures.

  • Rocuronium

    Rocuronium is a muscle relaxant used during surgery to facilitate intubation and provide muscle relaxation. It is administered intravenously and works by blocking the transmission of nerve impulses to the muscles. This results in temporary paralysis of the muscles, allowing surgeons to perform procedures without involuntary muscle movements. Rocuronium is known for its rapid onset and intermediate duration of action. It is often used in combination with anesthetics to enhance surgical conditions. The drug's effects are typically reversed at the end of the procedure to restore muscle function.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-515545-41-00Protocol codeAITT 2023/8Estimated enrolment20 patientsSponsorUniversity Of Debrecen

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