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

NCT03892122 | Unknown Phase 4

• 2 other identifiers: 01-192019-001429-28
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Drug-induced sleep endoscopy; Dexmedetomidine; Airway collapsibility; Propofol

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• pharyngeal and laryngeal patterns during DISE

  during DISE time (until 40 minutes)

Study Arms (2)

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

Drug: Propofol Fresenius

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.

Drug: Dexmedetomidine

Interventions

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.

Propofol group

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).

Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ospedale Monsignor R. Dimiccoli, Barletta: lead

Study Sites (1)

U.O.C. Otorinolaringoiatria Ospedale Di Barletta

Barletta, BAT, 76121, Italy

Location

Related Publications (6)

• 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.

  PMID: 30821349 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.

  PMID: 30515416 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.

  PMID: 30194726 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.

  PMID: 30133943 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.

  PMID: 28213776 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.

  PMID: 20811901 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michele Barbara, MD

  Otorhinolaryngology Department of Barletta's hospital

  PRINCIPAL INVESTIGATOR

• Francesco Barbara, MD

  Otorhinolaryngology department of " Policlinico di Bari"

  STUDY CHAIR

• Ilaria Alicino, MD

  Anesthesia Department of Barletta's hospital

  STUDY CHAIR

• Valentina Dibenedetto, MD

  Otorhinolaryngology Department of Barletta's hospital

  STUDY CHAIR

Central Study Contacts

Ilaria Alicino, MD

CONTACT

3334080997; i.alicino@libero.it

Valentina Dibenedetto, MD

CONTACT

3295435335; valedibe@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Otolaryngology

Model Details: it's a randomized controlled single center study

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 27, 2019
• Study Start: March 22, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)