Obstructive Sleep Apnea
Conditions
Keywords
Drug-induced sleep endoscopy, Dexmedetomidine, Airway collapsibility, Propofol
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)
Interventions
Propofol will be infused with TCI (Target Controlled Infusion) pump. TCI system has been developed to provide improved convenience and control during intravenous anaesthesia. The basic principle is that the anesthetist sets and adjusts the target blood concentration- and depth of anesthesia-as required on clinical grounds. Infusion rates are altered automatically according to a validated pharmacokinetic model. TCI technology uses different pharmacokinetic modeling to control the infusion rate of the pump, which allows for a direct control of the sedative agent brain concentration rather than its blood concentration. (de vito 2017) The development of target-controlled infusion (TCI) technology has increased the number of indications for propofol sedation in clinical practice. Furthermore, several studies have demonstrated that propofol-based TCI allows for the accurate control of sedation during DISE and results in an authentic reproduction of the sleep process.
DRUGDexmedetomidine
is a selective alpha-2 adrenergic receptor agonist, which seems to act on the locus coeruleus (LC) or to the preoptic hypothalamus to decrease wakefulness, with almost no effect on respiratory depression. Dexmedetomidine exerts its hypnotic action through activation of central pre- and postsyn¬aptic alpha2-receptors in the locus coeruleus, thereby inducting a state of unconsciousness similar to natural sleep, with the unique as¬pect that patients remain easily arousable and cooperative. Comparing with propofol, dexmedetomidine provides a state of sedation closer to natural sleep and lesser upper airways muscular relaxing effect, even at the increased anesthetic dosage Otherwise, Dexmedetomidine is characterized by a slightly longer onset of action (5-10 minutes), and patients take longer timing to recover..The sedative action of Dexmedetomidine can be reached by means of infusion technique (starting dose: 1 μg/kg over 10 minutes; maintenance infusion rate: 0,7 μg/kg/h).
Sponsors
Ospedale Monsignor R. Dimiccoli, Barletta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
it's a randomized controlled single center study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oxygen saturation variation during DISE | during DISE time (until 40 minutes) | every 5 minute will be recorded this variation and for all exam duration |
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactIlaria Alicino, MD
Backup ContactValentina Dibenedetto, MD
Outcome results
None listed