Actively Recruiting
The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscope in Adult: an Up and Down Sequential Trial
Led by Tongji Hospital · Updated on 2025-05-07
165
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the 90% effective dose (ED90) of remimazolam for anesthesia induction during drug-induced sleep endoscopy in adults with different body mass index (BMI) groups. This study aims to develop a more scientific and tailored sedation plan for patients undergoing this procedure. The trial is a phase 4, randomized, and double-blind study led by Tongji Hospital. Participants are divided into three groups based on their BMI: normal weight (BMI 18.5 to less than 24), overweight (BMI 24 to less than 30), and obese (BMI 30 and above). All participants receive remimazolam anesthesia induction during the endoscopy procedure. The study evaluates how the effective dose varies across these BMI groups. During the study, researchers will assess sedation levels using the Ramsey Sedation Scale within one day. They will also record treatment times, drug usage, and monitor respiratory suppression, treatment-emergent adverse events, and post-anesthesia care unit adverse reactions. The study includes close safety monitoring for up to two days after the procedure. Overall participation spans the procedure day and short-term follow-up.
CONDITIONS
Brief Title
ED90 of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscopy in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years old
- ASA physical status level I to III
- Signed informed consent form
You will not qualify if you...
- History of central nervous system diseases, cognitive disorders, mental disorders, or communication disorders
- Serious cardiovascular, respiratory, liver, or kidney disease
- Anticipated need for tracheal intubation or laryngeal mask
- Allergy to benzodiazepines or opioids
- Use of sedative, analgesic, or antidepressant drugs within 24 hours
- Abnormal liver or kidney function
- Recent participation in other clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive remimazolam anesthesia induction during drug-induced sleep endoscopy to explore the effective dose at different BMI groups.
1 treatment visit (in-person)
Duration - 2 days
Participants are monitored for adverse events and recovery following anesthesia induction.
Up to 2 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
M
mujun chang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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