ClinicalTrials.gg
Not yet recruitingNCT07459322Updated Aug 12, 2026

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

An interventional study of Remimazolam and Dexmedetomidine in OSAS (Obstructive Sleep Apneas Syndrome), DISE and Sedation, sponsored by Fu Jen Catholic University Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Fu Jen Catholic University Hospital · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 90 studies in Sleep Apnea, Obstructive with a site in Taiwan — 26 open to participants now, 27 under way, 3 of them phase 3. Sleep Apnea, Obstructive · Taiwan.

Planned enrollment
33rd of 58
60 · median 71
Started
2026
with 9 others
No phase
51 of 90
16 open now
Primary completion
2027-08
later than 13 of 26 live
Registered
82nd of 90
by date

Among the 90 studies in Sleep Apnea, Obstructive with a site in Taiwan, this one is the 33rd largest by planned enrollment of the 58 interventional ones that give a count, is one of 10 that started in 2026, is one of 51 with no phase, reaches primary completion later than 13 of the 26 other live ones, and was the 82nd registered.

Sleep Apnea, Obstructive

2,243 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

Browse Sleep Apnea, Obstructive studies →

Open to participants now

26 of the 90 studies in Sleep Apnea, Obstructive with a site in Taiwan are open now. Recruiting first, the newest first:

21 more — sign in →

All 26 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • OSAS (Obstructive Sleep Apneas Syndrome)
  • DISE
  • Sedation

Keywords

  • OSAS
  • DISE
  • Sedation
  • Remimazolam
  • Dexmedetomidine
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patient refusal
  • Allergic to experimental medication
  • History of central nervous system diseases
  • History of psychiatric diseases
  • Pregnancy
  • Severe, uncontrolled systemic diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Patients with OSAS receiving dexmedetomidine for sedation during DISE

    Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy

    Drug: Dexmedetomidine

  • Experimental
    Patients with OSAS receiving remimazolam for sedation during DISE

    Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy

    Drug: Remimazolam

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

06

What researchers measure

Primary outcomes

  1. Apneic events

    Apnea event during sedation

    Time frame: from start of sedation to outpatient discharge from postoperative care unit

  2. Bradycardia

    Heart rate less than 60 beats per minute during sedation

    Time frame: from start of sedation to outpatient discharge from postoperative care unit

  3. Hypotension

    Hypotensive event (defined as less mean blood pressure less than 80% of preoperative mean blood pressure) during sedation

    Time frame: from start of sedation to outpatient discharge from postoperative care unit

  4. Agitation

    Agitation, coughing, involuntary movement during sedation

    Time frame: from start of sedation to outpatient discharge from postoperative care unit

  5. Surgeon satisfaction score

    Rate of surgeon satisfaction of certain sedation

    Time frame: From start of sedation to outpatient discharge from postoperative care unit

  6. Hypoxic event

    hypoxic event during sedation

    Time frame: From start of sedation to outpatient discharge from postoperative care unit

Secondary outcomes

  1. Top-up requirement

    Additional sedative agents given during sedation

    Time frame: From start of sedation to outpatient discharge from postoperative care unit

  2. Patient satisfaction score

    validated questionnaire regarding anesthesia quality in chinese after sedation for patients

    Time frame: Before outpatient discharge from postoperative care unit

  3. VOTE classification prediction

    Using electronic stethescope to collect snoring noise and predict VOTE classification

    Time frame: Perioperative phase

07

Study locations

1 site
  • Fu Jen Catholic University Hosptial
    New Taipei City, Taiwan (r.o.c.) 24352, Taiwan
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 40142264 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.

Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 12 months is below that.

Counting every sponsor, half of 624 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2026
First posted
Mar 9, 2026
StartEst.
Aug 5, 2026
Primary completionEst.
Aug 5, 2027
CompletionEst.
Dec 31, 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07459322
Lead sponsor
Fu Jen Catholic University Hospital
Responsible party
Sponsor
First posted
Mar 9, 2026
Start date
Aug 5, 2026 (estimated)
Primary completion
Aug 5, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 12, 2026

Study contacts

Chao Hsien Sung, MD
Contact
joe411002@gmail.com
0905302091

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Remimazolam

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