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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with OSAS receiving dexmedetomidine for sedation during DISE | Active Comparator | Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy |
|
| Patients with OSAS receiving remimazolam for sedation during DISE | Experimental | Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apneic events | Apnea event during sedation | from start of sedation to outpatient discharge from postoperative care unit |
| Bradycardia | Heart rate less than 60 beats per minute during sedation | from start of sedation to outpatient discharge from postoperative care unit |
| Hypotension | Hypotensive event (defined as less mean blood pressure less than 80% of preoperative mean blood pressure) during sedation | from start of sedation to outpatient discharge from postoperative care unit |
| Agitation | Agitation, coughing, involuntary movement during sedation | from start of sedation to outpatient discharge from postoperative care unit |
| Surgeon satisfaction score | Rate of surgeon satisfaction of certain sedation | From start of sedation to outpatient discharge from postoperative care unit |
| Hypoxic event | hypoxic event during sedation | From start of sedation to outpatient discharge from postoperative care unit |
| Measure | Description | Time Frame |
|---|---|---|
| Top-up requirement | Additional sedative agents given during sedation | From start of sedation to outpatient discharge from postoperative care unit |
| Patient satisfaction score | validated questionnaire regarding anesthesia quality in chinese after sedation for patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Hsien Sung, MD | Contact | 0905302091 | joe411002@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Jen Catholic University Hosptial | New Taipei City | Taiwan (r.o.c.) | 24352 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33092317 | Background | Cheong CS, Loke W, Thong MKT, Toh ST, Lee CH. The Emerging Role of Drug-Induced Sleep Endoscopy in the Management of Obstructive Sleep Apnea. Clin Exp Otorhinolaryngol. 2021 May;14(2):149-158. doi: 10.21053/ceo.2020.01704. Epub 2020 Oct 16. | |
| 34998748 | Background | Lucas-Borja ME, Zema DA, Fernandez C, Soria R, Miralles I, Santana VM, Perez-Romero J, Del Campo AD, Delgado-Baquerizo M. Limited contribution of post-fire eco-engineering techniques to support post-fire plant diversity. Sci Total Environ. 2022 Apr 1;815:152894. doi: 10.1016/j.scitotenv.2021.152894. Epub 2022 Jan 5. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dexmedetomidine | Drug | Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy |
|
| Before outpatient discharge from postoperative care unit |
| 33918644 | Background | Chen YT, Sun CK, Wu KY, Chang YJ, Chiang MH, Chen IW, Liao SW, Hung KC. The Use of Propofol versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy: A Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2021 Apr 9;10(8):1585. doi: 10.3390/jcm10081585. |
| 38154891 | Background | Yan L, Wang X, Chen Z, Wu N, Li H, Yang B. Safety and efficacy of remimazolam tosilate combined with low-dose fentanyl for procedural sedation in obese patients undergoing gastroscopy: study protocol for a single-centre, double-blind, randomised controlled trial. BMJ Open. 2023 Dec 28;13(12):e079095. doi: 10.1136/bmjopen-2023-079095. |
| 40142264 | Background | Xin Y, Lu P, Guan S, Si S, Sun R, Xia W, Xu H. Efficacy and Safety of Remimazolam in Short Endoscopic Procedures: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2025 Mar 5;61(3):453. doi: 10.3390/medicina61030453. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |