Clinical trial NCT03892122: Efficacy and Stability of Dexmedetomidine Sedation Compared to Propofol Sedation in the Drug Induced Sleep Endoscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Drug-induced sleep endoscopy
Dexmedetomidine
Airway collapsibility
Propofol
Lead sponsor: Ospedale Monsignor R. Dimiccoli, Barletta
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: it's a randomized controlled single center study
Primary purpose: DIAGNOSTIC

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)

Eligibility 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.

Primary outcomes:
measure: oxygen saturation variation during DISE
timeFrame: during DISE time (until 40 minutes)
measure: hert rate variation during DISE
timeFrame: during DISE time (until 40 minutes)
measure: systolic and diastolic blood pressure variation during DISE
timeFrame: during DISE time (until 40 minutes)
measure: adverse events during DISE
timeFrame: during DISE time (until 40 minutes)
Secondary outcomes:
measure: pharyngeal and laryngeal patterns during DISE
timeFrame: during DISE time (until 40 minutes)
Other outcomes:
Locations:
city: Barletta
country: Italy
facility: U.O.C. Otorinolaringoiatria Ospedale Di Barletta
state: BAT
Study officials:
affiliation: Otorhinolaryngology Department of Barletta's hospital
name: Michele Barbara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Otorhinolaryngology department of " Policlinico di Bari"
name: Francesco Barbara, MD
role: STUDY_CHAIR
affiliation: Anesthesia Department of Barletta's hospital
name: Ilaria Alicino, MD
role: STUDY_CHAIR
affiliation: Otorhinolaryngology Department of Barletta's hospital
name: Valentina Dibenedetto, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.