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Active, Not Recruiting

NCT Number: NCT06784479

Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sedative Effect During Drug-induced Sleep Endoscopy Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea (OSA) Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Respiratory Endoscopy Center of Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Remimazolam and Propofol

Drug

Application of Remimazolam and Propofol to induce sleep

Propofol

Drug

Application of Propofol to induce sleep

Midazolam and propofol

Drug

Application of Midazolam and Propofol to induce sleep

Primary outcomes

  1. sedation success rate

    Time frame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

    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.

Secondary outcomes

  1. Procedure-related adverse effect-The need for antidote administration

    Time frame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

    Percentage of patients need for antidote administration

  2. Procedure-related adverse effect-The occurrence of tachycardia

    Time frame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

    Percentage of patients affected tachycardia（ECG monitor）

  3. Procedure-related adverse effect-The occurrence of hypotension

    Time frame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

    Percentage of patients affected hypotension（ECG monitor）

  4. Procedure-related adverse effect-The occurrence of hypoxemia

    Time frame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)

    Percentage of patients affected hypoxemia（ECG monitor）

  5. The degree of patient and physician satisfaction

    Time frame: During procedure (the start of drug induced sleep endoscopy to the complete awakening of the patient)

    The percentage of patient and physician satisfacted with the procedure

  6. Sedative effect-Adequate sedation time

    Time frame: During procedure (From the start of medication to target BIS range), an average of 2min

    The doctor evaluate the time it takes for the patient to reach a state of sufficient

  7. Sedative effect-sedation to recovery time

    Time frame: The time period of the end of operation to complete wakefulness,through operation completion, an average of 30min

    The process of a patient recovering from anesthesia to complete wakefulness

Sponsors and collaborators

Lead sponsor

Dan Liu

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Feb 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.

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