Sugammadex Dose Finding Under Two Years Old

Launched by SANG-HWAN JI · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medicine called sugammadex, which is used to help reverse the effects of a muscle relaxant called rocuronium during surgery. The study focuses on children under two years old to find out the right amount of sugammadex needed to quickly reverse muscle relaxation. The goal is to determine how much of the medicine is effective within two minutes, which is important for making sure children wake up safely after surgery.

To be eligible for this study, children must be younger than two years and scheduled for surgery that requires general anesthesia. They should be in good health, with no serious medical conditions affecting their heart, kidneys, or liver, and should not have any known allergies to the medications used in the study. Parents will be asked to consent to their child's participation, and the study is not yet open for recruitment. Families can expect that their child's safety and well-being will be a top priority throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia
• • American Society of Anesthesiologists Physical Status 1 or 2
• Exclusion Criteria:
• • History of hypersensitivity to rocuronium or any anesthetics
• • Presence of cardiovascular or genitourinary disease
• • Presence of severe renal dysfunction or in need of dialysis
• • Presence of severe hepatic dysfunction or coagualtion disorder
• • Current state of administration of neuromuscular blocking agent on admission to operating room
• • Concurrent use of any medications that affect the activity of neuromuscular blocking agents
• • History of malignant hyperthermia
• • Refusal to enroll in the study by one or more parents
• • Presence of any other reasons that investigator regards inappropriate to enroll in the study.