Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for De… (NCT05220462) | Clinical Trial Compass
UnknownPhase 3
Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for Dental Extractions.
United Kingdom128 participantsStarted 2022-03-09
Plain-language 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). Intravenous sedation is where a drug is injected into a patient's hand or arm. The drug stops them feeling worried, and helps them relax. After sedation, patients wait in a recovery area until they are safe to walk but the side effects of the drug can last until the next day. A new drug has been developed that has the same sedation effect and safety, but the recovery is much quicker. The investigators think that the side effects from the new drug will have worn off by the time patients are ready to leave the hospital. Patients who are coming to Guy's Hospital to have their wisdom tooth extracted under sedation will be asked if they want to be included in the research. Patients will be randomised to receive either remimazolam of standard of care midazolam. The sedation and dental treatment will be carried out in the normal way.
The patients will be asked to do will be some questionnaires and some tests which are as follows:
1. Patients are asked to listen to some words and repeat them back. This tests how well they can remember new information
2. Reaction test - Patients are asked to rest their fingers on a keypad and move their fingers when lights come on above them. This tests how quick their reactions are.
3. Symbol test- Patients are asked to draw small shapes that are linked to numbers. This tests how well they can process information.
4. Standing test- Patients are asked to stand on a platform that measures how much they are swaying back and forth. This tests how stable they are to walk.
By testing people before and after the sedation the investigators can see how they recovered and compare the two drugs. The research will take place during the day case visit and involve 2 x 30 mins research assessments (before sedation and post sedation). After the post-sedation tests, participants will be discharged, followed by a telephone review 3-10 days post procedure.
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Chro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hopkins Verbal Learning Test Revised (HVLT-R)
Timeframe: On day 1. At time T60 (60 minutes after last dose of IMP)