Status:
UNKNOWN
Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for Dental Extractions.
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Tooth Extraction
Eligibility:
All Genders
18-59 years
Phase:
PHASE3
Brief Summary
The study is looking to see if a new drug (remimazolam) that is used to sedate and relax adults (aged 18-59 years) having dental treatment is better than the current drug in use (midozolam). Intraveno...
Detailed Description
This study will be performed as a prospective, randomised, triple blind, active controlled, parallel group, single centre study design assessing enhanced cognitive recovery in patients having third mo...
Eligibility Criteria
Inclusion
- Patients who are scheduled to have mandibular third molar removal with intravenous conscious sedation.
- Male and female patients, aged ≥18 to ≤59 years old.
- American Society of Anesthesiologists (ASA-PS) grade I or II.
- 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.
- A patient who has given informed written consent for inclusion to the study.
- Patients who are willing and able to comply with study requirements.
Exclusion
- 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)
- 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.
- Any neurological deficit where cognitive tests will be impaired (for example dementia).
- A patient with known difficult airway/ mask ventilation or who has increased risk factors recorded by the clinical team at assessment.
- A patient who reports hypersensitive gag reflex.
- Body mass index \>34.9 kg/m or weight \<50kg or \>130kg.
- Dental or needle phobia identified by a modified dental anxiety score ≥19 (MDAS questionnaire).
- High Hospital Anxiety and Depression Score (HADS) \>12.
- Chronic use of benzodiazepines or opioids for any indication.
- Use of medications known to interact with IMP or comparator as listed in the SmPC.
- 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.
- Lactating female patients currently breastfeeding.
- Patients who self-report illicit drug use in the last 4 weeks. Patients who self-report alcohol abuse (AUDIT-C Scores \> 7) or history of abuse within the past 5 years.
- Patients who self-report a history of illicit drug abuse within the past 5 years or any history of benzodiazepine dependence.
- Inclusion in a study of an IMP in the previous 4 weeks or less than seven half-lives (whichever is the longer).
- Hypersensitivity to the IMP or to any of the excipients.
- Patients who are unable to stand unassisted.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05220462
Start Date
March 9 2022
End Date
September 1 2024
Last Update
December 5 2023
Active Locations (1)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT