The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 9, 2026
March 1, 2026
1 year
March 4, 2026
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Secondary Outcomes (2)
Top-up requirement
From start of sedation to outpatient discharge from postoperative care unit
Patient satisfaction score
Before outpatient discharge from postoperative care unit
Study Arms (2)
Patients with OSAS receiving dexmedetomidine for sedation during DISE
ACTIVE COMPARATORPatients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy
Patients with OSAS receiving remimazolam for sedation during DISE
EXPERIMENTALPatients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy
Interventions
Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy
Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy
Eligibility Criteria
You may qualify if:
- Patients age \> 18 years old
- American Society of Ansthesiologists functional class \< III
- Schedule to receive DISE exam for evaluation of OSAS
You may not qualify if:
- Patient refusal
- Allergic to experimental medication
- History of central nervous system diseases
- History of psychiatric diseases
- Pregnancy
- Severe, uncontrolled systemic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fu Jen Catholic University Hosptial
New Taipei City, Taiwan (r.o.c.), 24352, Taiwan
Related Publications (5)
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.
PMID: 33092317BACKGROUNDLucas-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.
PMID: 34998748BACKGROUNDChen 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.
PMID: 33918644BACKGROUNDYan 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.
PMID: 38154891BACKGROUNDXin Y,Lu P,Guan S,Si S,Sun R,Xia W,Xu H
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 9, 2026
Study Start
April 15, 2026
Primary Completion (Estimated)
April 15, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 9, 2026
Record last verified: 2026-03