drugset / Trial / NCT03892122

Efficacy and Stability of Dexmedetomidine Sedation Compared to Propofol Sedation in the Drug Induced Sleep Endoscopy

NCT03892122 ↗

Phase 4 Unknown 28 enrolled Ospedale Monsignor R. Dimiccoli, Barletta
RandomizedParallel-groupOpen-labelDiagnostic

Summary

Obstructive Sleep Apnea Syndrome affect up 12% in adult population. It is associated with an increase rate of hypertension, metabolic syndrome, depression and adverse cardiovascular events. The evaluation of upper airway obstruction is vital to obtain site-specific treatment. Drug Induced Sleep Endoscopy (DISE) is a routinely exam which allows the direct observation of the upper airway during sedative induced sleep. Propofol and Dexmedetomidine are sedatives approved for all diagnostic examinations that required sedation.

Timeline

Start
2019-03-22
Primary completion
2020-09
Completion
2020-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.7 ug/kg Intravenous
Subject Propofol Small molecule 2 ug/ml Intravenous
Subject Propofol Small molecule 2.5 ug/ml Intravenous