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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Lauren Arnold
+44 (0)2071887188 ext 54399
Lauren.arnold@gstt.nhs.uk


Dr Bryan Kerr
+44 (0)207 188 6076
bryan.kerr@kcl.ac.uk


Ms Chloe Christian
+44 (0)207 848 5958
Chloe.Christian@gstt.nhs.uk


Study Location:

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Be Part of Research - Trial Details - Remimazolam vs midazolam cognitive and motor recovery after intravenous conscious sedation for dental extractions
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Remimazolam vs midazolam cognitive and motor recovery after intravenous conscious sedation for dental extractions

Not Recruiting

Open to: All Genders

Age: Adult

London

Medical Conditions

Low risk mandibular third molar wisdom tooth extraction

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Over 12% of people in Britain are very anxious about dental work. Having teeth removed is often said to cause the most anxiety. Intravenous sedation is where a drug is injected into a patient’s hand or arm. The drug stops them from feeling worried and helps them relax and feel better able to cope. About half a million sedations for dental treatment are carried out in England each year. Sedation is very safe, and people generally say that they have had a good experience. After sedation patients wait in a recovery area until they are safe to walk. They usually go home after about an hour, but the side effects of the drug can last until the next day. This can cause people to forget important things, like putting a cooker on, and to feel heavy and sleepy and risk bumping into things for the rest of the day. A new drug (remimazolam) is in development that has the same sedation effect and safety, but the recovery is much quicker. It is thought that the side effects from the new drug will have worn off by the time patients are ready to leave the hospital. This means patients might feel more alert going home and better able to look after themselves. The aim of this study is to find out whether remimazolam is better than the current drug that is used (midazolam) and allows patients to recover faster and feel better quicker after surgery.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

09 Mar 2022 01 Feb 2023

Patients are randomly picked by a computer to be given the new or old drug. On the day of the appointment participants will be asked to follow all the normal sedation instructions. The sedation and dental treatment will be carried out in the normal way. The only extra things will be some questionnaires and some tests. This will add an extra 2 hours to the appointment time. Participants will only be discharged on the day of the procedure with an accompanying person.
There are four research tests. In the learning test participants will be asked to listen to some words and repeat them back. This tests how well they can remember new information. In the reaction test participants will be 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. In the symbol test participants will be asked to draw small shapes that are linked to numbers. This tests how well they can process information. In the standing test participants will be asked to stand on a platform that measures how much they are swaying back and forth. This tests how stable they are to walk. These tests are designed to check different ways the brain and body are affected by the sedation. By testing people before and after the sedation the researchers can see how they recovered. They will then check the results of the new and existing drugs to see if people having the new drug recovered quicker.
The researchers plan to phone patients a few days after their appointment to check they were happy with the sedation. They will also check they did not have any side effects from the medication. The phone call will take about 20 minutes. Normal fasting instructions will be given and standard of care leaflets. Participants will be are asked to refrain from alcohol, using heavy machinery, making important decisions or taking non-prescription drugs for at least 24 hours after the procedure. Painkillers like paracetamol may be recommended by the doctor as per standard of care.


Patients aged between 18 and 59 years who are coming to Guy’s Hospital to have their wisdom tooth extracted under sedation

You can take part if:



You may not be able to take part if:


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 failure3. 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 assessment5. A patient who reports hypersensitive gag reflex6. Body mass index >34.9 kg/m2 or weight <50kg or >130kg7. Dental or needle phobia identified by a modified dental anxiety score ≥19 (MDAS questionnaire)8. High Hospital Anxiety and Depression Score (HADS) >129. Chronic use of benzodiazepines or opioids for any indication10. Use of medications known to interact with IMP or comparator as listed in the SmPC11. 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 breastfeeding13. Patients who self-report illicit drug use in the last 4 weeks14. Patients who self-report alcohol abuse (AUDIT-C Scores > 7) or a history of abuse within the past 5 years15. Patients who self-report a history of illicit drug abuse within the past 5 years or any history of benzodiazepine dependence16. 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 excipients18. 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Guy’s Hospital
    Floor 26 Tower Wing
    London
    SE1 9RT

The patient will be asked to attend the hospital early on the day of the procedure for consent and will have two 30 minute episodes of memory and balance testing (one before procedure and one after procedure). This will add about 2 hours onto the normal treatment time but the patient is not required to wait in the Dental Institute between the first set of assessments and their procedure appointment. A member of the research team will be with the patient and can help with any questions during the testing. The tests were reviewed by the patient representative group and were not perceived to be burdensome.
The sedation and surgical tooth removal procedure will be carried out in the same way as patients who are not in the study. From published clinical trials and medication information available, the risks are the same as the standard of care and have been identified and mitigated by the use of monitoring by appropriately trained staff.
It is not anticipated that the patient will receive any direct benefit by participating in the trial. However, the patient will receive up to £60 reimbursement to cover reasonable expenses, including travel expenses, for themselves and their accompanying person.

Dr Bryan Kerr
+44 (0)207 188 6076
bryan.kerr@kcl.ac.uk


Ms Lauren Arnold
+44 (0)2071887188 ext 54399
Lauren.arnold@gstt.nhs.uk


Ms Chloe Christian
+44 (0)207 848 5958
Chloe.Christian@gstt.nhs.uk



The study is sponsored by Guy's and St Thomas' NHS Foundation Trust and funded by Paion AG.



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Read full details for Trial ID: ISRCTN35903062

Or CPMS 49437

Last updated 05 September 2022

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