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A randomized controlled study of intravenous sedation with remimazolam and propofol in tooth extraction

A randomized controlled study of intravenous sedation with remimazolam and propofol in tooth extraction

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058106
Enrollment
Unknown
Registered
2022-03-29
Start date
2022-04-05
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Intravenous sedation Intravenous analgesia Tooth extraction

Interventions

Remimazolam:Induce 0.08ug/kg/min, pump continuously for 1min and maintain 0.3ug/kg/h
Alfentanil 0.3ug/kg/min pump injection,After local anesthesia
Alfentanil 0.2ug/kg/min pump injection
Propofol:The target concentration of propofol was 1.8ug/ml and alfentanil was 0.3ug/kg/min
After local anesthesia, propofol maintained the target control concentration of 1.5ug/ml

Sponsors

Stomatological Hospital Affiliated to Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients receiving tooth extraction; 2. Aged 18-60; 3.kg/m2=BMI=30kg/m2 4. ASA Class I-II; 5. I agree and sign the Informed Consent for Clinical Research.

Exclusion criteria

Exclusion criteria: 1. Have a history of nervous system disease; 2. Have serious systemic diseases above ASA Class II; 3. Known allergy to benzodiazepines or local anesthetics; 4. Pregnant or lactating patients; 5. Refuse to treat under sedation; 6. Suspected or confirmed history of alcohol and drug abuse; 7. Extraction of teeth in emergency period such as pericoronitis of wisdom teeth; 8. Participated in other clinics in recent three months.

Design outcomes

Primary

MeasureTime frame
Mean arterial pressure;Heart Rate;Modified observer’s assessment of alert;Modified dental anxiety scale;Oxygen saturation;

Secondary

MeasureTime frame
Visual Analogue Scale/Score;

Countries

China

Contacts

Public ContactCong Yu

Stomatological Hospital Affiliated to Chongqing Medical University

500158@hospital.cqum.edu.cn+86 13996202110

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026