Sedative Effect During Drug-induced Sleep EndoscopyPhase 4NCT06784479
Combination of Remimazolam and Propofol During Drug-induced Sleep Endoscopy
A Phase 4 study testing Remimazolam and Propofol, Propofol and Midazolam and propofol in people with Sedative Effect During Drug-induced Sleep Endoscopy and Obstructive Sleep Apnea (OSA), run by Dan Liu at 1 site in China.
Trial summary
This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sedative Effect During Drug-induced Sleep Endoscopy, Obstructive Sleep Apnea (OSA)
- What is being tested?
- Remimazolam and Propofol, Propofol and Midazolam and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with sleep apnea hypopnea syndrome were included
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Respiratory Endoscopy Center of Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
About this study
Official title: 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
- Being tested
- Remimazolam and Propofol, Propofol, Midazolam and propofol
- Keywords
- drug-induced sleep endoscopy, remimazolam, propofol, Obstructive sleep apnea, airway collapsibility
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam and PropofolDrug
Application of Remimazolam and Propofol to induce sleep
PropofolDrug
Application of Propofol to induce sleep
Midazolam and propofolDrug
Application of Midazolam and Propofol to induce sleep
| Study group | Role | What they receive |
|---|---|---|
| Application of remimazolam and propofol to achieve satisfactory sedative effect | Experimental | Not described Receives: Drug: Remimazolam and Propofol |
| Application of propofol to achieve satisfactory sedative effect | Active comparator | Not described Receives: Drug: Propofol |
| Application of midazolam and propofol to achieve satisfactory sedative effect | Active comparator | Not described Receives: Drug: Midazolam and propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
Secondary outcomes (7)
Procedure-related adverse effect-The need for antidote administration
Percentage of patients need for antidote administration
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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
Measured: 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
Measured: During procedure (From the start of medication to target BIS range), an average of 2min
Sedative effect-sedation to recovery time
The process of a patient recovering from anesthesia to complete wakefulness
Measured: The time period of the end of operation to complete wakefulness,through operation completion, an average of 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedative Effect During Drug-induced Sleep EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Liu, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784479
- Sponsor's protocol ID
- IRB2024-YX-607-01
- Other IDs
- 82300120
- Status last verified
- Feb 2026
- First submitted
- 31 Dec 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Evaluate the Sedative Effect of the Combination of Remimazolam and Propofol in Drug-induced Sleep Endoscopy
- ClinicalTrials.gov ID
- NCT06784479
- Acronym / sponsor ID
- IRB2024-YX-607-01
- Keywords
- drug-induced sleep endoscopy, remimazolam, propofol, Obstructive sleep apnea, airway collapsibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Dan LiuUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Application of remimazolam and propofol to achieve satisfactory sedative effect | Experimental | Drug: Remimazolam and Propofol |
| Application of propofol to achieve satisfactory sedative effect | Active comparator | Drug: Propofol |
| Application of midazolam and propofol to achieve satisfactory sedative effect | Active comparator | Drug: Midazolam and propofol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with sleep apnea hypopnea syndrome were included
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam and PropofolApplication of Remimazolam and Propofol to induce sleep | Drug | Application of remimazolam and propofol to achieve satisfactory sedative effect |
| PropofolApplication of Propofol to induce sleep | Drug | Application of propofol to achieve satisfactory sedative effect |
| Midazolam and propofolApplication of Midazolam and Propofol to induce sleep | Drug | Application of midazolam and propofol to achieve satisfactory sedative effect |
Primary outcome
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.
7 secondary outcomes
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)
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)
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)
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)
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)
Sedative effect-Adequate sedation time
Time frame: During procedure (From the start of medication to target BIS range), an average of 2min
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam and Propofol, Propofol and Midazolam and propofol in people with Sedative Effect During Drug-induced Sleep Endoscopy and Obstructive Sleep Apnea (OSA), run by Dan Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sedation success rate (time frame: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.