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

Obstructive Sleep Apnea Clinical Trial

Official title:
Randomised Monocentric -Controlled Study to Evaluate the Efficacy and Stability of Dexmedetomidine Sedation Compared to Propofol Sedation in the Routinely Diagnostic Examination: Drug Induced Sleep Endoscopy

Clinical Trial 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.

Clinical Trial Description

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 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.

It's a Randomized Controlled study. 28 participants will be enrolled and randomized in two groups: in the first group the sedation state will be performed with Propofol, while in the second group will be used Dexmedetomidine for allow sedation state. The study will be evaluate the different hemodynamic and respiratory changes during sedation in these two different groups and differences in obstructive endoscopic anatomical patterns. This will be the first study in whic Dexmedetomidine and Propofol will be compared according to European DISE Recommendation published in august 2018 (references) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03892122
Study type Interventional
Source Ospedale Monsignor R. Dimiccoli, Barletta
Contact Ilaria Alicino, MD
Phone 3334080997
Email i.alicino@libero.it
Status Not yet recruiting
Phase Phase 4
Start date March 22, 2019
Completion date September 2020
View Details
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