Determining the optimal dose of remimazolam for anesthesia during sleep endoscopy in adults
The 90% Effective Dose (ED90) of Remimazolam Anesthesia Induction in Drug-induced Sleep Endoscope in Adult: an up and Down Sequential Trial
PHASE4 · Tongji Hospital · NCT06333145
This study is testing the best dose of remimazolam to safely sedate adults during sleep endoscopy while considering their body weight.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06333145 on ClinicalTrials.gov |
What this trial studies
This study investigates the effective dose (ED90) of remimazolam for anesthesia induction during drug-induced sleep endoscopy in adults, focusing on different body mass index (BMI) groups. The goal is to establish a scientifically-based sedation protocol that enhances safety and efficacy during the procedure. Participants will be monitored for their response to the medication, allowing for tailored dosing based on individual characteristics. The study aims to improve sedation practices in clinical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with an ASA physical status classification of I-III who can provide informed consent.
Not a fit: Patients with a history of central nervous system diseases, serious cardiovascular or respiratory conditions, or those requiring tracheal intubation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer sedation protocols for patients undergoing drug-induced sleep endoscopy.
How similar studies have performed: While studies on sedation protocols exist, this specific investigation into remimazolam's ED90 in relation to BMI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Age 18-65 years old, 2. ASA Ⅰ-Ⅲ level; 3. Sign an informed consent form. 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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: mujun chang
- Email: changmujun@hotmail.com
- Phone: +862783663625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Effect of Drug, Drug-induced Sleep Endoscopy, remimazolam, ED90