Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575036
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Sugammadex Dose Finding Under Two Years Old
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old a Prospective Dose Finding Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dose and 95 effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method
Detailed Description:
The investigators are planning to enroll 33 patients to obtain data The starting dose of sugammadex will be 05mgkg When the dose for a patient was not effective the dose for next patient will be increased by 05mgkg When the dose was effective the dose for next patient will be decreased by 05mgkg or maintained with a 11 of allocation ratio
The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old
The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None