NCT06575036

Sugammadex Dose Finding Under Two Years Old

Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old: a Prospective Dose Finding Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Sang-Hwan Ji · Academic / Other
• Sex: All
• Age: 23 Months
• Healthy volunteers: Not accepted

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 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 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.

Conditions

• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	Sugammadex	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 increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.

Timeline

• Start date: 2024-09-15
• Primary completion: 2025-04-30
• Completion: 2025-05-31
• First posted: 2024-08-28
• Last updated: 2024-08-29

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study