Comparing Remimazolam and Midazolam for Dental Sedation Recovery

A Phase III Randomised, Triple-blind Controlled Superiority Trial of Remimazolam (CNS 7056), Compared to Midazolam, in Adults Having Lower Third Molar Wisdom Tooth Extraction Under Intravenous Conscious Sedation to Assess Cognitive and Motor Recovery at Normal Discharge Time

This study is testing if a new sedation drug called remimazolam helps people recover faster in their thinking and movement after having their wisdom teeth removed compared to the standard drug midazolam.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: Guy's and St Thomas' NHS Foundation Trust (other)
• Locations: 1 site (London)
• Trial ID: NCT05220462 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of remimazolam compared to midazolam in aiding cognitive and motor recovery after intravenous sedation for dental extractions. It involves a prospective, randomized, triple-blind design with 128 participants scheduled for wisdom tooth removal. Patients will be randomly assigned to receive either remimazolam or midazolam, with the aim of determining if the new drug allows for quicker recovery from sedation. The study will assess cognitive function using a validated test to measure memory performance post-sedation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 59 scheduled for wisdom tooth extraction requiring intravenous sedation.

Not a fit: Patients with contraindications to benzodiazepines or those at high surgical risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to faster recovery times for patients undergoing dental procedures under sedation.

How similar studies have performed: Other studies have shown promising results with remimazolam, suggesting potential advantages over traditional sedatives like midazolam.

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.

Where this trial is running

London

• Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Bryan Kerr — Guy's and St Thomas' NHS Foundation Trust
• Study coordinator: Bryan Kerr

Conditions: Tooth Extraction