Status:
NOT_YET_RECRUITING
Sugammadex Dose Finding Under Two Years Old
Lead Sponsor:
Sang-Hwan Ji
Conditions:
Neuromuscular Blockade
Eligibility:
All Genders
Up to 23 years
Phase:
PHASE2
Brief Summary
This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective ...
Detailed Description
The investigators are planning to enroll 33 patients to obtain data. The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06575036
Start Date
September 15 2024
End Date
May 31 2025
Last Update
August 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, South Korea, 03080