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Remimazolam and Fentanyl for Procedural Sedation in Dental Extraction
NCT06793358Phase 4
Key facts
- Status
- Withdrawn
- Start
- Jul 2025
- Primary completion
- Feb 2026
- Countries
- 1
- Sponsor
- Indiana University
- Modality
- Orthosteric Ligands
- Drugs
- remimazolamfentanyl
- Conditions
- tooth extraction
01
Overview
Phase 4, open-label, single-arm trial of remimazolam and fentanyl in tooth extraction, sponsored by Indiana University. Primary endpoints: Successful extraction of teeth at 30 minutes, Modified Observer's Assessment of Alertness/Sedation at 30 minutes and 1 more. Planned start Jul 2025; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Fentanyl and Remimazolam combined
Single arm receiving remimazolam and fentanyl for procedural sedation.
03
Who it enrols
Healthy adults (ASA 1 or 2) with BMI <= 30 kg/m2 scheduled for dental extractions under IV moderate sedation lasting 30 minutes or less.
04
Endpoints
Primary
Successful extraction of teeth
Modified Observer's Assessment of Alertness/Sedation
No need for rescue medications
Secondary
Timing related to anesthesia length, surgery, eye opening and discharge
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