Effect of DrugPhase 4NCT06333145
ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults
A Phase 4 study testing Remimazolam in people with Effect of Drug, run by Tongji Hospital at 1 site in China.
Trial summary
Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Remimazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 4 Feb 2024to 20 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18-65 years old, 2. ASA Ⅰ-Ⅲ level; 3. Sign an informed consent form.
Who cannot join
- 1.A history of central nervous system diseases, cognitive disorders, mental disorders, or communication disorders; 2.serious cardiovascular, respiratory, liver or kidney disease; 3.Anticipated need for tracheal intubation or laryngeal mask; 4.Allergic to benzodiazepines and opioids; 5.Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; 6.Abnormal liver and kidney function; 7.Recently participated in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscope in Adult: an up and Down Sequential Trial
Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups.
Read the detailed description
Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups, to provide a more scientific medication scheme for sedation in Drug-induced Sleep Endoscopy.
- Conditions
- Effect of Drug
- Being tested
- Remimazolam
- Keywords
- Drug-induced Sleep Endoscopy, remimazolam, ED90
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Remimazolam besylate
Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy
| Study group | Role | What they receive |
|---|---|---|
| normal group | Experimental | BMI: ≥18.5 and <24 Receives: Drug: Remimazolam |
| overweight group | Experimental | BMI: ≥24 and <30 Receives: Drug: Remimazolam |
| obese group | Experimental | BMI: ≥30 Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ramsey Sedation Scale
Using the Ramsey Sedation Scale scoring table ranging from 1-6 to evaluate if the sedation is successful
1point: Patients are anxious, restless or irritable; 2point: Patients cooperative, well-oriented and quiet; 3point: Patients fall asleep and respond only to commands; 4point: Patients fall asleep and respond quickly to eyebrow taps or loud auditory stimuli; 5point: Patients fall asleep and are blunt to respond to eyebrow taps or loud auditory stimuli; 6point: Patients fall asleep and do not respond to the above stimuli.
Measured: 1 day
Secondary outcomes (5)
Time records
Anesthesia time, induction time, surgical time, awakening time and recovery time
Measured: 1 day
Use of drugs
The total amount of sedative and analgesic drugs used.
Measured: 1 day
Respiratory suppression incidence
Respiratory frequency<8 times/min or SP02<90%
Measured: 1 day
Incidence of Treatment-Emergent Adverse Events
Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc.
Measured: 2 days
Incidence of PACU Adverse Reactions
Nausea and vomiting, pain (VAS score), hypotension, bradycardia, dizziness;
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start4 Feb 2024
- Primary completion20 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- Aihua Du, Dr, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333145
- Sponsor's protocol ID
- EDRA
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: You can request it from the main researcher.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscope in Adult: an up and Down Sequential Trial
- ClinicalTrials.gov ID
- NCT06333145
- Acronym / sponsor ID
- EDRA
- Conditions
- Effect of Drug
- Keywords
- Drug-induced Sleep Endoscopy, remimazolam, ED90
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 27 Mar 2024 (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.
Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups.
Detailed description
Exploring the ED90 of remimazolam in Drug-induced Sleep Endoscopy in adults at different BMI groups, to provide a more scientific medication scheme for sedation in Drug-induced Sleep Endoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal group | Experimental | Drug: RemimazolamBMI: ≥18.5 and <24 |
| overweight group | Experimental | Drug: RemimazolamBMI: ≥24 and <30 |
| obese group | Experimental | Drug: RemimazolamBMI: ≥30 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age 18-65 years old, 2. ASA Ⅰ-Ⅲ level; 3. Sign an informed consent form.
Key exclusion criteria (1 listed)
- 1.A history of central nervous system diseases, cognitive disorders, mental disorders, or communication disorders; 2.serious cardiovascular, respiratory, liver or kidney disease; 3.Anticipated need for tracheal intubation or laryngeal mask; 4.Allergic to benzodiazepines and opioids; 5.Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; 6.Abnormal liver and kidney function; 7.Recently participated in other clinical studies.
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 |
|---|---|---|
| RemimazolamAlso: Remimazolam besylateExploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy | Drug | normal group, obese group, overweight group |
Primary outcome
Ramsey Sedation Scale
Time frame: 1 day
Using the Ramsey Sedation Scale scoring table ranging from 1-6 to evaluate if the sedation is successful 1point: Patients are anxious, restless or irritable; 2point: Patients cooperative, well-oriented and quiet; 3point: Patients fall asleep and respond only to commands; 4point: Patients fall asleep and respond quickly to eyebrow taps or loud auditory stimuli; 5point: Patients fall asleep and are blunt to respond to eyebrow taps or loud auditory stimuli; 6point: Patients fall asleep and do not respond to the above stimuli.
5 secondary outcomes
Time records
Time frame: 1 day
Use of drugs
Time frame: 1 day
Respiratory suppression incidence
Time frame: 1 day
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 days
Incidence of PACU Adverse Reactions
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. You can request it from the main researcher.
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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.
Aihua Du, Dr study chair
Tongji Hospital
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 in people with Effect of Drug, run by Tongji Hospital 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: finished, as of the sponsor's last update on 1 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ramsey Sedation Scale (time frame: 1 day). 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 1 Jul 2026.