320
Participants
Start Date
August 10, 2019
Primary Completion Date
January 1, 2021
Study Completion Date
May 20, 2022
intranasal dexmedetomidine
"Phase 1, Children received a bolus of intranasal dexmedetomidine which adjusted by the Dixon up-and-down method for TEE study. The first child received 2.5 mcg/kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose varied by 0.1 mcg/kg according to the up-and-down method Phase 2 was a dose-escalation study. After interim analysis of the phase 1 results, four dose levels above the calculated ED50 were defined. Dose spacing was set at 0.25 mcg/kg of intranasal dexmedetomidine consistent with the re-estimated standard deviation (SD)."
Department of Anesthesiology of Guangzhou Women and Children's Medical Center, Guangzhou
Guangzhou Women and Children's Medical Center
OTHER