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

March 4, 2026 updated by: Fu Jen Catholic University Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan (r.o.c.)
      • New Taipei City, Taiwan (r.o.c.), Taiwan, 24352
        • Fu Jen Catholic University Hosptial
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy
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
Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apneic events
Time Frame: from start of sedation to outpatient discharge from postoperative care unit
Apnea event during sedation
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
Heart rate less than 60 beats per minute during sedation
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
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
Time Frame: from start of sedation to outpatient discharge from postoperative care unit
Agitation, coughing, involuntary movement during sedation
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
Rate of surgeon satisfaction of certain sedation
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
hypoxic event during sedation
From start of sedation to outpatient discharge from postoperative care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Top-up requirement
Time Frame: From start of sedation to outpatient discharge from postoperative care unit
Additional sedative agents given during sedation
From start of sedation to outpatient discharge from postoperative care unit
Patient satisfaction score
Time Frame: Before outpatient discharge from postoperative care unit
validated questionnaire regarding anesthesia quality in chinese after sedation for patients
Before outpatient discharge from postoperative care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJUH114458

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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