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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001429-28 | EudraCT Number |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol group | Other | 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 |
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| Dexmedetomidine group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol Fresenius | Drug | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilaria Alicino, MD | Contact | 3334080997 | i.alicino@libero.it | |
| Valentina Dibenedetto, MD | Contact | 3295435335 | valedibe@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michele Barbara, MD | Otorhinolaryngology Department of Barletta's hospital | Principal Investigator |
| Francesco Barbara, MD | Otorhinolaryngology department of " Policlinico di Bari" | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O.C. Otorinolaringoiatria Ospedale Di Barletta | Barletta | BAT | 76121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30821349 | Background | Padiyara TV, Bansal S, Jain D, Arora S, Gandhi K. Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial. Laryngoscope. 2020 Jan;130(1):257-262. doi: 10.1002/lary.27903. Epub 2019 Mar 1. | |
| 30515416 | Background | Zhao LL, Liu H, Zhang YY, Wei JQ, Han Y, Han L, Yang JP. A Comparative Study on Efficacy and Safety of Propofol versus Dexmedetomidine in Sleep Apnea Patients undergoing Drug-Induced Sleep Endoscopy: A CONSORT-Prospective, Randomized, Controlled Clinical Trial. Biomed Res Int. 2018 Nov 1;2018:8696510. doi: 10.1155/2018/8696510. eCollection 2018. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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it's a randomized controlled single center study
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| Dexmedetomidine | Drug | 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). |
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| Ilaria Alicino, MD | Anesthesia Department of Barletta's hospital | Study Chair |
| Valentina Dibenedetto, MD | Otorhinolaryngology Department of Barletta's hospital | Study Chair |
| 30194726 | Background | Viana A, Zhao C, Rosa T, Couto A, Neves DD, Araujo-Melo MH, Capasso R. The Effect of Sedating Agents on Drug-Induced Sleep Endoscopy Findings. Laryngoscope. 2019 Feb;129(2):506-513. doi: 10.1002/lary.27298. Epub 2018 Sep 7. |
| 30133943 | Background | De Vito A, Carrasco Llatas M, Ravesloot MJ, Kotecha B, De Vries N, Hamans E, Maurer J, Bosi M, Blumen M, Heiser C, Herzog M, Montevecchi F, Corso RM, Braghiroli A, Gobbi R, Vroegop A, Vonk PE, Hohenhorst W, Piccin O, Sorrenti G, Vanderveken OM, Vicini C. European position paper on drug-induced sleep endoscopy: 2017 Update. Clin Otolaryngol. 2018 Dec;43(6):1541-1552. doi: 10.1111/coa.13213. Epub 2018 Sep 30. |
| 28213776 | Background | De Vito A, Agnoletti V, Zani G, Corso RM, D'Agostino G, Firinu E, Marchi C, Hsu YS, Maitan S, Vicini C. The importance of drug-induced sedation endoscopy (D.I.S.E.) techniques in surgical decision making: conventional versus target controlled infusion techniques-a prospective randomized controlled study and a retrospective surgical outcomes analysis. Eur Arch Otorhinolaryngol. 2017 May;274(5):2307-2317. doi: 10.1007/s00405-016-4447-x. Epub 2017 Feb 17. |
| 20811901 | Background | De Vito A, Agnoletti V, Berrettini S, Piraccini E, Criscuolo A, Corso R, Campanini A, Gambale G, Vicini C. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study. Eur Arch Otorhinolaryngol. 2011 Mar;268(3):457-62. doi: 10.1007/s00405-010-1376-y. Epub 2010 Sep 2. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |