Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07459322

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

OSAS (Obstructive Sleep Apneas Syndrome) Apnea DISE Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sedation Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fu Jen Catholic University Hosptial

New Taipei City, Taiwan (r.o.c.), 24352, Taiwan

Location contact

Chao-Hsien Sung, MD

CONTACT

[email protected]

886905302091

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

Drug

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

Dexmedetomidine

Drug

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

Primary outcomes

  1. Apneic events

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

    Apnea event during sedation

  2. Bradycardia

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

    Heart rate less than 60 beats per minute during sedation

  3. 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

  4. Agitation

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

    Agitation, coughing, involuntary movement during sedation

  5. Surgeon satisfaction score

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

    Rate of surgeon satisfaction of certain sedation

  6. Hypoxic event

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

    hypoxic event during sedation

Secondary outcomes

  1. Top-up requirement

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

    Additional sedative agents given during sedation

  2. Patient satisfaction score

    Time frame: Before outpatient discharge from postoperative care unit

    validated questionnaire regarding anesthesia quality in chinese after sedation for patients

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Hsien Sung, MD

CONTACT

[email protected]

0905302091

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.