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
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- adverse events during DISE
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Apnea-Hypopnea Index (AHI) of 15-
- •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.
Arms & Interventions
Propofol group
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
Intervention: Propofol Fresenius (Drug)
Dexmedetomidine 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.
Intervention: Dexmedetomidine (Drug)
Outcomes
Primary Outcomes
adverse events during DISE
Time Frame: during DISE time (until 40 minutes)
Number of Participants with arterial hypotension, hypertension; number of desaturation episodes below 60%; rate of patients with heart rate below 50 beats per minute.
hert rate variation during DISE
Time Frame: during DISE time (until 40 minutes)
every 5 minute will be recorded this variation and for all exam duration
systolic and diastolic blood pressure variation during DISE
Time Frame: during DISE time (until 40 minutes)
every 5 minute will be recorded this variation and for all exam duration
oxygen saturation variation during DISE
Time Frame: during DISE time (until 40 minutes)
every 5 minute will be recorded this variation and for all exam duration
Secondary Outcomes
- pharyngeal and laryngeal patterns during DISE(during DISE time (until 40 minutes))
Investigators
Michele Barbara
Director, Head of Otolaryngology
Ospedale Monsignor R. Dimiccoli, Barletta