Safety and efficacy of remimazolam in oral comfort

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200066544

Enrollment

Unknown

Registered

2022-12-08

Start date

2022-12-15

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

None listed

Interventions

Remimazolam group:0.1 mg/kg remazolam

Midazolam group:0.05 mg/kg midazolam

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients who have received tooth extraction and have high dental phobia; 2. Aged between 18 and 60 years; 3. BMI18-30kg/m^2; 4. ASA ? ~ ?; 5. The patient agrees and signs the informed consent for clinical study.

Exclusion criteria

Exclusion criteria: 1. History of nervous system; 2. Have serious systemic disease; 3. Severe abnormal functions of heart, lung, liver and kidney; 4. Known allergy to benzodiazepines or local anesthesia drugs; 5. Pregnant or lactating patients; 6. Refusal to be treated under sedation; 7. Suspected or confirmed history of alcohol and drug abuse; 8. Patients with pericoronitis and other emergency periods of wisdom teeth extraction; 9. Participated in other clinical trials within the last three months.

Design outcomes

Primary

Measure	Time frame
Success rate of sedation;Compliance;Visual analogue scale for pain;Modified observer's assessment of alert;Wake up time;	—

Countries

China

Contacts

Public ContactZhang Tiejun

Hospital of Stomatology Wuhan University

784047004@qq.com+86 18854036987

Outcome results