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

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Propofol Fresenius
Dexmedetomidine
Sponsored by
Ospedale Monsignor R. Dimiccoli, Barletta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring Drug-induced sleep endoscopy, Dexmedetomidine, Airway collapsibility, Propofol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • U.O.C. Otorinolaringoiatria Ospedale Di Barletta

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Propofol group

Dexmedetomidine group

Arm 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

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.

Outcomes

Primary Outcome Measures

oxygen saturation variation during DISE
every 5 minute will be recorded this variation and for all exam duration
hert rate variation during DISE
every 5 minute will be recorded this variation and for all exam duration
systolic and diastolic blood pressure variation during DISE
every 5 minute will be recorded this variation and for all exam duration
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2019
Last Updated
March 27, 2019
Sponsor
Ospedale Monsignor R. Dimiccoli, Barletta
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1. Study Identification

Unique Protocol Identification Number
NCT03892122
Brief Title
Efficacy and Stability of Dexmedetomidine Sedation Compared to Propofol Sedation in the Drug Induced Sleep Endoscopy
Acronym
DISERT
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Monsignor R. Dimiccoli, Barletta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Drug-induced sleep endoscopy, Dexmedetomidine, Airway collapsibility, Propofol

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
it's a randomized controlled single center study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol group
Arm Type
Other
Arm 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
Arm Title
Dexmedetomidine group
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Propofol Fresenius
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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).
Primary Outcome Measure Information:
Title
oxygen saturation variation during DISE
Description
every 5 minute will be recorded this variation and for all exam duration
Time Frame
during DISE time (until 40 minutes)
Title
hert rate variation during DISE
Description
every 5 minute will be recorded this variation and for all exam duration
Time Frame
during DISE time (until 40 minutes)
Title
systolic and diastolic blood pressure variation during DISE
Description
every 5 minute will be recorded this variation and for all exam duration
Time Frame
during DISE time (until 40 minutes)
Title
adverse events during DISE
Description
Number of Participants with arterial hypotension, hypertension; number of desaturation episodes below 60%; rate of patients with heart rate below 50 beats per minute.
Time Frame
during DISE time (until 40 minutes)
Secondary Outcome Measure Information:
Title
pharyngeal and laryngeal patterns during DISE
Description
pharyngeal and laryngeal patterns observed during DISE will be compared with patterns observed during awake endoscopic evaluation, the vote classification will be used
Time Frame
during DISE time (until 40 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilaria Alicino, MD
Phone
3334080997
Email
i.alicino@libero.it
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Dibenedetto, MD
Phone
3295435335
Email
valedibe@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Barbara, MD
Organizational Affiliation
Otorhinolaryngology Department of Barletta's hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Barbara, MD
Organizational Affiliation
Otorhinolaryngology department of " Policlinico di Bari"
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ilaria Alicino, MD
Organizational Affiliation
Anesthesia Department of Barletta's hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Valentina Dibenedetto, MD
Organizational Affiliation
Otorhinolaryngology Department of Barletta's hospital
Official's Role
Study Chair
Facility Information:
Facility Name
U.O.C. Otorinolaringoiatria Ospedale Di Barletta
City
Barletta
State/Province
BAT
ZIP/Postal Code
76121
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ILARIA ALICINO, MD
Phone
3334080997
Email
i.alicino@libero.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30821349
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.
Results Reference
background
PubMed Identifier
30515416
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.
Results Reference
background
PubMed Identifier
30194726
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.
Results Reference
background
PubMed Identifier
30133943
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.
Results Reference
background
PubMed Identifier
28213776
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.
Results Reference
background
PubMed Identifier
20811901
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.
Results Reference
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Efficacy and Stability of Dexmedetomidine Sedation Compared to Propofol Sedation in the Drug Induced Sleep Endoscopy

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