Ongoing Clinical Trials for Craniosynostosis
There is currently 1 ongoing clinical trial for craniosynostosis, a condition where the bones in a baby’s skull join together too early. This trial is taking place in Hungary and focuses on improving surgical safety by studying how muscle relaxant medication works in infants during corrective surgery.
Clinical trial locations
- Hungary
Study on Rocuronium Bromide for Neuromuscular Block in Infants with Craniosynostosis During Surgery
This trial is studying how a muscle relaxant medication called rocuronium bromide works in infants who are having surgery to correct the early joining of skull bones. The condition affects the shape of the head and can impact brain development, so surgery is often needed to correct it.
Who can participate:
- Infants between 3 and 12 months old
- Both male and female infants are welcome
- Parents must provide written consent after understanding the study details
- The study is looking for 20 infants to participate
Who cannot participate:
- Infants outside the 3-12 month age range
- Infants with medical conditions that might interfere with study results
- Infants with known allergies to rocuronium, sevoflurane, or propofol (the medications used in the study)
- Infants currently participating in another clinical trial
- Infants with significant medical conditions that could affect their safety during the study
What the trial focuses on:
The main goal is to understand how different doses of rocuronium bromide work to relax muscles during surgery. Muscle relaxation is important because it makes it easier for surgeons to perform the procedure safely. The researchers are particularly interested in how rocuronium interacts with two types of anesthesia commonly used to keep infants asleep and pain-free during surgery: sevoflurane, which is inhaled through a mask, and propofol, which is given through an IV.
During the surgery, doctors will monitor how long the muscle relaxation lasts and how the medication works with the anesthesia. The information gathered could help doctors use these medications more safely and effectively in future surgeries for young patients.
Investigational drugs being tested:
- Rocuronium bromide: A muscle relaxant given intravenously (through a vein) to temporarily paralyze muscles during surgery, making surgical procedures easier to perform
- Sevoflurane: An inhaled anesthetic gas that keeps patients unconscious during surgery, being studied to see how it affects rocuronium’s action
- Propofol: An intravenous anesthetic that maintains unconsciousness during surgery, being studied to understand its interaction with rocuronium
Summary
Currently, there is one clinical trial available for infants with craniosynostosis, located in Hungary. This trial focuses on optimizing the use of muscle relaxants during corrective surgery, which is an important aspect of surgical safety for this young patient population. The study investigates how different anesthetic approaches may influence the effectiveness of rocuronium bromide, potentially leading to safer anesthesia protocols for infants undergoing skull surgery. Parents of eligible infants interested in participating should discuss this opportunity with their child’s medical team.
