DISE, OSAS (Obstructive Sleep Apneas Syndrome), Sedation
Conditions
Keywords
OSAS, DISE, Sedation, Remimazolam, Dexmedetomidine
Brief summary
This study seeks to compare the clinical efficacy and safety of the novel sedative Remimazolam with Dexmedetomidine in Drug-Induced Sleep Endoscopy (DISE), evaluating their performance in sedation depth stability, incidence of adverse events, and postoperative recovery time, thereby providing evidence-based guidance for sedative selection in OSA patients. Additionally, it aims to develop a model for predicting upper airway obstruction sites by analyzing Polysomnography (PSG) data with artificial intelligence, enhancing diagnostic accuracy and treatment decision-making efficiency for Obstructive Sleep Apnea (OSA) to optimize clinical management.
Interventions
DRUGRemimazolam
Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy
DRUGDexmedetomidine
Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy
Sponsors
Fu Jen Catholic University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients age \> 18 years old * American Society of Ansthesiologists functional class \< III * Schedule to receive DISE exam for evaluation of OSAS
Exclusion criteria
* Patient refusal * Allergic to experimental medication * History of central nervous system diseases * History of psychiatric diseases * Pregnancy * Severe, uncontrolled systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apneic events | from start of sedation to outpatient discharge from postoperative care unit | Apnea event during sedation |
| Bradycardia | from start of sedation to outpatient discharge from postoperative care unit | Heart rate less than 60 beats per minute during sedation |
| Hypotension | from start of sedation to outpatient discharge from postoperative care unit | Hypotensive event (defined as less mean blood pressure less than 80% of preoperative mean blood pressure) during sedation |
| Agitation | from start of sedation to outpatient discharge from postoperative care unit | Agitation, coughing, involuntary movement during sedation |
| Surgeon satisfaction score | From start of sedation to outpatient discharge from postoperative care unit | Rate of surgeon satisfaction of certain sedation |
| Hypoxic event | From start of sedation to outpatient discharge from postoperative care unit | hypoxic event during sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Top-up requirement | From start of sedation to outpatient discharge from postoperative care unit | Additional sedative agents given during sedation |
| Patient satisfaction score | Before outpatient discharge from postoperative care unit | validated questionnaire regarding anesthesia quality in chinese after sedation for patients |
| VOTE classification prediction | Perioperative phase | Using electronic stethescope to collect snoring noise and predict VOTE classification |
Countries
Taiwan
Contacts
CONTACTChao Hsien Sung, MD
Outcome results
None listed