ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study

PHASE4CompletedINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

August 10, 2019

Primary Completion Date

January 1, 2021

Study Completion Date

May 20, 2022

Conditions
Patients for Transthoracic EchocardiographyUnknown Diagnosis
Interventions
DRUG

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)."

Trial Locations (1)

510000

Department of Anesthesiology of Guangzhou Women and Children's Medical Center, Guangzhou

All Listed Sponsors
lead

Guangzhou Women and Children's Medical Center

OTHER

NCT02780427 - ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study | Biotech Hunter | Biotech Hunter