Remimazolam vs midazolam cognitive and motor recovery after intravenous conscious sedation for dental extractions

Not Applicable

• Conditions: ow risk mandibular third molar wisdom tooth extraction; Oral Health

• Registration Number: ISRCTN35903062
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-09
• Last Update Posted: 19 September 2022
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 128

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

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 <50kg or >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified