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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Propofol Fresenius
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: it's a randomized controlled single center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Propofol group<br>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 | Drug: Propofol Fresenius<br>* 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.<br>|
| Other: Dexmedetomidine group<br>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. | Drug: Dexmedetomidine<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharyngeal and laryngeal patterns during DISE | pharyngeal and laryngeal patterns observed during DISE will be compared with patterns observed during awake endoscopic evaluation, the vote classification will be used | during DISE time (until 40 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-induced sleep endoscopy, Dexmedetomidine, Airway collapsibility, Propofol