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

• Status: Unknown status
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ospedale Monsignor R. Dimiccoli, Barletta
• Treatments: Dexmedetomidine; Propofol

Criteria

Inclusion Criteria:

• Apnea-Hypopnea Index (AHI) of 15-30.

• Men and women, age 18-65 years, Body Mass Index (BMI) < 35 Kg/m2,

• Awake oxygen saturation > 95%

• Able to read and sign the consent form

Exclusion Criteria:

• Chronic Obstructive Pulmonary Disease (COPD)

• Liver disease (Child Pugh 1-3)

• History of chronic use of sedatives, narcotics, alcohol or illicit drugs,

• History of 1st and 2nd degree heart block (not paced),

• Left Ventricular Ejection Fraction (LVEF) < 50%,

• Allergy to propofol or Dexmedetomidine,

• OSHAS (Obstructive sleep apnea/hypopnea syndrome) surgical failure patients

• Pregnant women.