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

ConditionsOSAS (Obstructive Sleep Apneas Syndrome)DISESedation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFu Jen Catholic University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients age > 18 years old

American Society of Ansthesiologists functional class < III

Schedule to receive DISE exam for evaluation of OSAS

Disqualifiers

Patient refusal

Allergic to experimental medication

History of central nervous system diseases

History of psychiatric diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Patients with OSAS receiving dexmedetomidine for sedation during DISEActive comparator 1 intervention
Group B: Patients with OSAS receiving remimazolam for sedation during DISEExperimental treatment 1 intervention

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fu Jen Catholic University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: