Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for Dental Extractions.

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Jan 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a new drug called remimazolam works better for helping adults relax during dental procedures, specifically tooth extractions, compared to the commonly used drug midazolam. Both drugs are given through an injection in the arm to help patients feel calm and comfortable while their dentist works on their teeth. The researchers believe that remimazolam helps patients recover faster, allowing them to feel more alert and ready to leave the hospital sooner after their procedure.

To participate in this study, you need to be an adult between 18 and 59 years old who is scheduled to have a wisdom tooth removed under sedation. If you join the study, you will receive either remimazolam or midazolam and will undergo some simple tests before and after the sedation to measure your memory, reaction time, and stability. You will also complete a few questionnaires. The entire process will take place during your dental visit, and you will have a follow-up phone call about a week later to check on how you are feeling. It's important to know that this study is looking for volunteers, so if you're interested, you can ask your dentist at Guy's Hospital for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.