CClinicalTrials.gg
CompletedNCT06333145Updated Jul 1, 2026

ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults

A Phase 4 interventional study of Remimazolam in Effect of Drug, sponsored by Tongji Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Tongji Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Effect of Drug

Keywords

  • Drug-induced Sleep Endoscopy
  • remimazolam
  • ED90
03

In context

Lead sponsor

Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 1. Age 18-65 years old, 2. ASA Ⅰ-Ⅲ level; 3. Sign an informed consent form.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    normal group

    BMI: ≥18.5 and \<24

    Drug: Remimazolam

  • Experimental
    overweight group

    BMI: ≥24 and \<30

    Drug: Remimazolam

  • Experimental
    obese group

    BMI: ≥30

    Drug: Remimazolam

Interventions

  • DrugRemimazolam

    Exploring ED90 induced by remimazolam anesthesia in adults of different BMI groups undergoing drug-induced sleep endoscopy

    Also known as: Remimazolam besylate

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. Time records

    Anesthesia time, induction time, surgical time, awakening time and recovery time

    Time frame: 1 day

  2. Use of drugs

    The total amount of sedative and analgesic drugs used.

    Time frame: 1 day

  3. Respiratory suppression incidence

    Respiratory frequency\<8 times/min or SP02\<90%

    Time frame: 1 day

  4. 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.

    Time frame: 2 days

  5. Incidence of PACU Adverse Reactions

    Nausea and vomiting, pain (VAS score), hypotension, bradycardia, dizziness;

    Time frame: 1 day

07

Study locations

1 site
  • Tongji Hospital
    Wuhan, Hubei 430000, China
08

References and documents

Individual participant data

Plan to share: No — You can request it from the main researcher.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06333145
Lead sponsor
Tongji Hospital
Responsible party
aijun xu (Clinical Professor, Tongji Hospital) — Principal investigator
First posted
Mar 27, 2024
Start date
Feb 4, 2024
Primary completion
Jun 20, 2026
Completion
Jun 20, 2026
Last update
Jul 1, 2026

Study contacts

Aihua Du, Dr
study chair · Tongji Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion