Low risk mandibular third molar wisdom tooth extraction Oral Health
Conditions
Interventions
Participants will be randomised in a 1:1 ratio (remimazolam: midazolam). Randomisation will use permuted blocks of varying sizes and will be undertaken via a bespoke online randomisation service.
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 11/05/2022: 1. Patients who are scheduled to have mandibular third molar removal with intravenous conscious sedation 2. Male and female patients, aged =18 to =59 years old 3. American Society of Anesthesiologists (ASA-PS) grade I or II 4. English as their first or main language for =5 years. The primary outcome measure (HVLT) is a cognitive test to remember English words and validated on this basis 5. A patient who has given informed written consent for inclusion to the study 6. Patients who are willing and able to comply with study requirements Previous participant inclusion criteria: 1. Healthy adult male and female patients aged between 18 and 59 years old 2. Scheduled to have low risk mandibular third molar wisdom tooth extraction with intravenous conscious sedation
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 11/05/2022: 1. Any surgical risk factor which, in the opinion of the study surgeon, can lead to increased procedure complexity (for example high risk of inferior alveolar nerve damage) 2. A known sensitivity to benzodiazepines or a medical condition such that these agents are contraindicated as per the SmPC, for example unstable myasthenia gravis, hepatic impairment, acute respiratory depression, and severe respiratory failure 3. Any neurological deficit where cognitive tests will be impaired (for example dementia) 4. A patient with known difficult airway/ mask ventilation or who has increased risk factors recorded by the clinical team at assessment 5. A patient who reports hypersensitive gag reflex 6. Body mass index >34.9 kg/m2 or weight 130kg 7. Dental or needle phobia identified by a modified dental anxiety score =19 (MDAS questionnaire) 8. High Hospital Anxiety and Depression Score (HADS) >12 9. Chronic use of benzodiazepines or opioids for any indication 10. Use of medications known to interact with IMP or comparator as listed in the SmPC 11. All female patients with a positive urine pregnancy test within 8 hours before IMP administration. Female patients who are permanently sterile are not required to have a urine test. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. 12. Lactating female patients currently breastfeeding 13. Patients who self-report illicit drug use in the last 4 weeks 14. Patients who self-report alcohol abuse (AUDIT-C Scores > 7) or a history of abuse within the past 5 years 15. Patients who self-report a history of illicit drug abuse within the past 5 years or any history of benzodiazepine dependence 16. Inclusion in a study of an IMP in the previous 4 weeks or less than seven half-lives (whichever is the longer) 17. Hypersensitivity to the IMP or to any of the excipients 18. Patients who are unable to stand unassisted Previous participant exclusion criteria: Known sensitivity to benzodiazepines or a medical condition or concomitant medication such that these agents are cautioned or contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verbal learning measured using the Hopkins Verbal Learning Test Revised (HVLT(R)) at baseline and 60 min from last dose of Investigational Medicinal Product (IMP) vs midazolam (T60) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recovery measured using the proportion of patients returning to within 1 standard error (SE) of pre-dose cognitive and motor testing, measured using HVLT(R), Digit Symbol Substitution Test (DSST), Multi-Operational Apparatus for Reaction Time (MOART) and sway scores at baseline and 60 min from last IMP dose (T60) 2. Cognitive operation measured using the Digit Symbol Substitution Test (DSST) at baseline and 60 min from last IMP dose (T60) 3. Sway measured using the scales for assessment and rating of ataxia (balance board) at baseline and T60 4. Reaction time measured using MOART device by choice reaction time (with Go/No Go) at baseline and last dose of IMP (T60) 5. The times to fully alert (first of three Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of 5) after the end of the procedure (surgical “time out”) and after the last IMP dose (T60) 6. The times to ready for discharge after the end of the procedure (surgical “time out”) measured using Clinical Walk and orientation test 7. The overall co-operation score given by the surgical team (Dental Sedation Teacher Groups (DSTG) score) at end of the procedure 8. Occurrence of pain on injection at the application of study medication measured using the visual analogue score (VAS) at dosing 9. The procedure failure rate due to inadequate sedation at the maximum dose/top-up rate measured using the number of failures at the end of the trial 10. Comparative safety measures of adverse events measured using the number of adverse events at the end of the trial | — |
Countries
England, United Kingdom
Contacts
Public ContactChloe Christian
Outcome results
None listed