drugset / Trial / NCT03800641

A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

NCT03800641 ↗

Phase 4 Completed 45 enrolled Eye & ENT Hospital of Fudan University
RandomizedParallel-groupTriple-blindPrevention

Summary

Proper preoperative sedation can reduce patients' anxiety, enhance patients' cooperation and reduce perioperative complications. The investigators would explore the sedative effects of dexmedetomidine (DEX) with the administration of oral, intravenous and nasal drops, and detect DEX blood concentration in 15 participants, respectively. Pharmacokinetic parameters are detected at 8 time points ( before DEX administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration). 3 ml arterial blood was collected at each time point. The blood samples are detected by mass spectrometer. The aim of this study is to investigate appropriate administration time and route for DEX sedation.

Timeline

Start
2019-01-11
Primary completion
2019-03-29
Completion
2020-01-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.8 ug/kg Oral
Subject Dexmedetomidine Other / unclassified 1 ug/kg Oral
Subject Dexmedetomidine Other / unclassified 4 ug/kg Oral

Indications