Determination of Median Effective Dose (ED50) of Remimazolam in Oral Surgery Tooth Extraction Using BIS Monitoring and Sequential Method

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500110943

Enrollment

Unknown

Registered

2025-10-23

Start date

2023-09-11

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comfortable anesthesia in oral outpatient clinics

Interventions

Single group:This study aims to determine the median effective dose (ED50) of remimazolam for outpatient dental extraction under BIS-guided sequential dosing. Remimazolam is administered via intraveno

if the response is negative (Ramsay score <2 or presence of grimacing/body movement), the next dose is increased to 1.1 times the previous dose. The trial proceeds sequentially until the 11th response

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for outpatient dental extraction; 2. Age 18–60 years; 3. ASA physical status I–II; 4. BMI: 18–24 kg/m^2; 5. No restriction on gender; 6. No history of sedative or psychotropic drug use; 7. No history of asthma or upper respiratory tract infection; 8. No history of drug allergy; 9. No long-term medication use.

Exclusion criteria

Exclusion criteria: The patient is unable to cooperate; Having mental illness;

Design outcomes

Primary

Measure	Time frame
Remazolam half effective dose;	—

Countries

China

Contacts

Public ContactZhao Juzhao

Shenzhen Stomatology Hospital

2586810091@qq.com+86 136 5216 9305

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026