Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy

A Randomized Clinical Trial to Evaluate the Sedative Effect of the Combination of Remimazolam and Propofol in Drug-induced Sleep Endoscopy

This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea (OSA); Sedative Effect During Drug-induced Sleep Endoscopy
• Intervention / Treatment: Drug: Remimazolam and Propofol; Drug: Propofol; Drug: Midazolam and propofol

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Respiratory Endoscopy Center of Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with sleep apnea hypopnea syndrome were included

Exclusion Criteria:

• Patients were excluded if they had nasal obstruction, significantly deviated nasal septum, nasal turbinate hypertrophy, or nasal polyps. Patients with uncontrolled heart failure, renal insufficiency, diabetes, or hyperthyroidism were also excluded. Patients were also excluded if taking medications that could affect upper airway muscle function, such as ben- zodiazepines and muscle relaxants.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application of remimazolam and propofol to achieve satisfactory sedative effect	Drug: Remimazolam and Propofol; Application of Remimazolam and Propofol to induce sleep
Active Comparator: Application of propofol to achieve satisfactory sedative effect	Drug: Propofol; Application of Propofol to induce sleep
Active Comparator: Application of midazolam and propofol to achieve satisfactory sedative effect	Drug: Midazolam and propofol; Application of Midazolam and Propofol to induce sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation success rate	a composite measure including completion of the DISE, no requirement for rescue sedative medication, and no requirement for more than 5 top-up doses of the trial medication after the initial dose.	During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedative effect-sedation to recovery time	The process of a patient recovering from anesthesia to complete wakefulness	The time period of the end of operation to complete wakefulness,through operation completion, an average of 30min
Procedure-related adverse effect-The need for antidote administration	Percentage of patients need for antidote administration	During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
Procedure-related adverse effect-The occurrence of tachycardia	Percentage of patients affected tachycardia（ECG monitor）	During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
Procedure-related adverse effect-The occurrence of hypotension	Percentage of patients affected hypotension（ECG monitor）	During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
Procedure-related adverse effect-The occurrence of hypoxemia	Percentage of patients affected hypoxemia（ECG monitor）	During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
The degree of patient and physician satisfaction	The percentage of patient and physician satisfacted with the procedure	During procedure (the start of drug induced sleep endoscopy to the complete awakening of the patient)
Sedative effect-Adequate sedation time	The doctor evaluate the time it takes for the patient to reach a state of sufficient	During procedure (From the start of medication to target BIS range), an average of 2min

Collaborators and Investigators

• Sponsor: Dan Liu

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; propofol; drug-induced sleep endoscopy; remimazolam; airway collapsibility
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Benzazepines; Benzodiazepines; Midazolam; Propofol; remimazolam
• Other Study ID Numbers: IRB2024-YX-607-01; 82300120 (Other Grant/Funding Number: National Natural Science Foundation of China)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No