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

Phase 4

Brief 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.

Detailed 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)

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Propofol group	Propofol Fresenius	Sleep endoscopy will be performed by a Target Controlled Infusion system (BRAUN perfusion system) using Schneider model in effect-site (cerebral) targeted infusion 50-ml prefilled syringe of 1% propofol. Schneider system is a complex pharmacokinetic/pharmacodynamic (PK/PD) model that allows to obtain different rates of drug from the values of age, height, weight and lean body mass of the patient . The starting dose of propofol will be 2-2,5 mcg ml-1 and increments of 0.2 mcg ml-1 took place when the new cerebral concentration of propofol will be reached, and never before 5 minutes. In this way, the investigators will be realized a slow technique of TCI propofol infusion according to European working group
Dexmedetomidine group	Dexmedetomidine	For the D-DISE group, dexmedetomidine will be administered with an IV infusion at 1 mcg/kg over 10 minutes, followed by a maintenance rate of 0,7 mcg/kg/h.

Primary Outcome Measures

Name	Time	Method
adverse events during DISE	during DISE time (until 40 minutes)	Number of Participants with arterial hypotension, hypertension; number of desaturation episodes below 60%; rate of patients with heart rate below 50 beats per minute.
hert rate variation during DISE	during DISE time (until 40 minutes)	every 5 minute will be recorded this variation and for all exam duration
systolic and diastolic blood pressure variation during DISE	during DISE time (until 40 minutes)	every 5 minute will be recorded this variation and for all exam duration
oxygen saturation variation during DISE	during DISE time (until 40 minutes)	every 5 minute will be recorded this variation and for all exam duration

Secondary Outcome Measures

Name	Time	Method
pharyngeal and laryngeal patterns during DISE	during DISE time (until 40 minutes)	pharyngeal and laryngeal patterns observed during DISE will be compared with patterns observed during awake endoscopic evaluation, the vote classification will be used

Locations (1): U.O.C. Otorinolaringoiatria Ospedale Di Barletta
🇮🇹
Barletta, BAT, Italy