MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA
Launched by ISTITUTO GIANNINA GASLINI · Mar 25, 2024
Trial Information
Current as of July 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a special method called quantitative neuromuscular monitoring during anesthesia in young children. Neuromuscular monitoring helps doctors know when to safely reverse the effects of muscle relaxants used during surgery. The trial will compare two groups of children aged between 2 months and 6 years who are undergoing elective non-cardiac surgeries that last about one to two hours. One group will have their muscle activity monitored using advanced technology, while the other group will rely on standard practices without that technology.
To participate in this trial, children must be healthy enough for surgery and not have certain medical conditions, such as severe neuromuscular diseases or allergies to the medications being used. A total of 200 children will be involved, and their experiences will be closely observed to see how well the different monitoring methods work. Parents or guardians will provide informed consent, meaning they will understand and agree to their child's participation in the study. This research aims to improve safety and minimize complications during and after surgery for young patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Children aged 2 months to 6 years of age
- • Children undergoing elective non-cardiac surgery with an estimated anesthesia time of about 60 to 120 minutes
- • ASA ≤ 2
- • Acquisition of informed consent by a legally recognised representative able to understand the document and provide consent on behalf of the participant.
- Exclusion Criteria:
- • Children under 2 months or over 6 years of age
- • Children with ASA classification ≥ 3
- • Presence of neuromuscular diseases, channelopathies or any clinical condition contraindicating the administration of neuromuscular muscle relaxants
- • Confirmed or suspected allergy to the active substance
- • Presence of amputation or limb malformations that make the positioning of neuromuscular monitoring impossible
- • Any specific contraindication to any aspect of the protocol
About Istituto Giannina Gaslini
Istituto Giannina Gaslini is a renowned pediatric research institute located in Genoa, Italy, dedicated to advancing child health through innovative clinical research and high-quality care. As a leading center in pediatric medicine, the institute focuses on a wide range of specialties, including oncology, immunology, and rare diseases. Committed to improving patient outcomes, Istituto Giannina Gaslini actively engages in clinical trials that explore new therapeutic strategies and enhance existing treatments. With a multidisciplinary team of experts, the institute fosters collaboration with national and international partners to contribute to the global body of pediatric medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported