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Not yet recruiting NCT07459322

The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy

No phase Interventional OSAS (Obstructive Sleep Apneas Syndrome) DISE Sedation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remimazolam, Dexmedetomidine.
Who it may be relevant to
Registry conditions: OSAS (Obstructive Sleep Apneas Syndrome), DISE, Sedation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Drug Remimazolam
    Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy
  • Drug Dexmedetomidine
    Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy

Primary outcome measures

  • Apneic events [Time frame: from start of sedation to outpatient discharge from postoperative care unit]
  • Bradycardia [Time frame: from start of sedation to outpatient discharge from postoperative care unit]
  • Hypotension [Time frame: from start of sedation to outpatient discharge from postoperative care unit]
  • Agitation [Time frame: from start of sedation to outpatient discharge from postoperative care unit]
  • Surgeon satisfaction score [Time frame: From start of sedation to outpatient discharge from postoperative care unit]
  • Hypoxic event [Time frame: From start of sedation to outpatient discharge from postoperative care unit]
Secondary outcome measures (2)
  • Top-up requirement [Time frame: From start of sedation to outpatient discharge from postoperative care unit]
  • Patient satisfaction score [Time frame: Before outpatient discharge from postoperative care unit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Fu Jen Catholic University Hosptial — New Taipei City

Publications

  • 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 33092317
  • 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. PMID 34998748
  • 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. PMID 33918644
  • 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. PMID 38154891
  • 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. PMID 40142264

Identifiers

NCT: NCT07459322 · FJUH114458

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗