Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Remimazolam vs Midazolam for Sedation in Wisdom Tooth Extraction
NCT05220462Phase 3
Key facts
- Status
- Recruiting
- Start
- Mar 2022
- Primary completion
- May 2024
- Countries
- 1
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Modality
- Small Molecules
- Drugs
- remimazolam
- Conditions
- Procedural sedation (PS)
01
Overview
Phase 3, randomised, triple-blind trial of remimazolam in Procedural sedation (PS) (2 arms), sponsored by Guy's and St Thomas' NHS Foundation Trust. Primary endpoint: Hopkins Verbal Learning Test Revised. Started Mar 2022; status: recruiting.
02
Design
2 arms- Study design
- RandomizedTriple-blind
Remimazolam
Remimazolam IV titration
Midazolam
Midazolam IV titration (Standard of Care)
03
Who it enrols
Adults aged 18-59 scheduled for mandibular third molar removal under IV sedation, ASA grade I or II, English speakers. Excludes patients with surgical risk factors, benzodiazepine sensitivity, neurological deficits, difficult airway, hypersensitive gag reflex, BMI >34.9 or weight <50kg/>130kg, dental/needle phobia, high anxiety/depression scores, chronic benzo/opioid use, or history of substance abuse.
04
Endpoints
Primary
Hopkins Verbal Learning Test Revised
Secondary
Cognitive and Motor Testing
Digit Symbol Substitution Test
Balance Board
Multi-Operational Apparatus for Reaction Time
Time to Start of Procedure
Modified Observer's Assessment of Alertness/Sedation
Ready for Discharge
Dental Sedation Teachers Group Score
Beyond the preview
Go deeper on NCT05220462.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT05220462.