The efficacy and safety of remimazolam compared with midazolam in patients undergoing dental extraction

The efficacy and safety of remimazolam compared with midazolam in patients undergoing dental extraction - a randomized, controlled, multicentered trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100050822

Enrollment

Unknown

Registered

2021-09-04

Start date

2021-09-20

Completion date

Unknown

Last updated

2023-07-30

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

Conditions

Dental extraction

Interventions

Remimazolam group:The initial dose of remimazolam is 0.1mg/kg, with an additional dose of 2mg, meeting the MOAA/S score of = 4 points during the procedure

Midazolam group:The initial dose of midazolam is 0.05mg/kg, with an additional dose of 1mg, meeting the MOAA/S score of = 4 points during the procedure

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients receiving tooth extraction under sedation; 2. Aged 18 to 60 years; 3. 18 kg/m^2 < BMI < 30 kg/m^2; 4. ASA I - II; 5. Informed consent got from patients.

Exclusion criteria

Exclusion criteria: 1. History of nervous system; 2. Have serious systemic diseases; 3. Known allergy to benzodiazepines or local anesthetics; 4. Pregnant or lactating patients; 5. Suspected or true history of alcohol and drug abuse; 6. Acute infection of pericoronitis of wisdom teeth; 7. Participated in other clinical trials in recent three months.

Design outcomes

Primary

Measure	Time frame
Success of sedation;	—

Secondary

Measure	Time frame
Frankl Scale;Visual analogue scale (VAS) of local anesthesia;Visual analogue scale (VAS) of procedure;Pain on injection at application of the study medication;Fluctuation of vital signs;Time to peak sedation after administration of the first dose of medication;Time to local anesthesia after administration of the first dose of medication;Times to fully alert (first of 3 MOAA/S scores of 5 after end of the procedure) ;Times to fully alert (first of 3 MOAA/S scores of 5 after administration of the last dose of medication);Times to readiness for discharge after the end of the procedure;Times to readiness for discharge after the last dose of the medication;Fluctuation of MOAA/S;Satisfaction of patients, anesthesiologists and dentists;adverse events during the procedure;Complications related to medication;	—

Measure

Time frame

Frankl Scale;Visual analogue scale (VAS) of local anesthesia;Visual analogue scale (VAS) of procedure;Pain on injection at application of the study medication;Fluctuation of vital signs;Time to peak sedation after administration of the first dose of medication;Time to local anesthesia after administration of the first dose of medication;Times to fully alert (first of 3 MOAA/S scores of 5 after end of the procedure) ;Times to fully alert (first of 3 MOAA/S scores of 5 after administration of the last dose of medication);Times to readiness for discharge after the end of the procedure;Times to readiness for discharge after the last dose of the medication;Fluctuation of MOAA/S;Satisfaction of patients, anesthesiologists and dentists;adverse events during the procedure;Complications related to medication;

—

Countries

China

Contacts

Public ContactZhang Hui

School of Stomatology, the Fourth Military Medical University

zhanghuifmmua@163.com+86 29 8477 6115

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026