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

Ospedale Monsignor R. Dimiccoli, Barletta

Status and phase: Unknown; Phase 4

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Dexmedetomidine; Drug: Propofol Fresenius

Study type: Interventional

Funder types: Other

Identifiers

NCT03892122

2019-001429-28 (EudraCT Number)

01-19

Details and patient eligibility

About

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.

Full 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)

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Propofol group

Other group

Description:

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

Treatment:

Drug: Propofol Fresenius

Dexmedetomidine group

Other group

Description:

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.

Treatment:

Drug: Dexmedetomidine