Tooth ExtractionPhase 3REMIDENTNCT05220462

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

A Phase 3 study testing Remimazolam and Midazolam in people with Tooth Extraction, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 59 years
Conditions the study is for: Tooth Extraction
What is being tested?: Remimazolam and Midazolam
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 siteUnited Kingdom
Study dates: 9 Mar 2022to 1 Sep 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Bryan Kerr contact

02071887188

bryan.kerr@kcl.ac.uk

United Kingdom1 site, 1 recruiting

Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Bryan Kerr, 02071887188, bryan.kerr@kcl.ac.uk
Recruiting

Other trials in United Kingdom

About this study

Official title: 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

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:

Patients are asked to listen to some words and repeat them back. This tests how well they can remember new information
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.
Symbol test- Patients are asked to draw small shapes that are linked to numbers. This tests how well they can process information.
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.

Read the 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 molar wisdom tooth extraction under intravenous conscious sedation with remimazolam. An active control group has been chosen using intravenous midazolam which is the current standard of care in Dentistry. 128 patients will be randomised, of which n=64 will receive remimazolam, and n=64 in the midazolam group.

Conditions: Tooth Extraction
Being tested: Remimazolam, Midazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemimazolamDrug
As per Remimazolam arm
MidazolamDrug
As per Midazolam arm

Study groups in NCT05220462
Study group	Role	What they receive
Remimazolam	Experimental	White to off-white lyophilised powder, presented in a 12 mL clear glass vial with a grey bromobutyl stopper, fitted with an aluminium crimp and a blue plastic flip-off cap. Each 20 mg vial of remimazolam, will be reconstituted with sterile 0.9% NaCl solution to yield a 2.5 mg/mL solution for injection. An initial dose of 5mg (2mL) over 60 seconds, pausing for 90 seconds, followed by 2.5mg (1mL) over 30 seconds and waiting 30 seconds will be titrated to response end point. Subsequent doses of 2.5mg (1 mL) increments can be administered if required should the procedure take longer, or the patient recover more quickly than expected, to maintain the sedation level. Top-up doses will be administered slowly, at least 2 minutes apart. Top-up doses will be limited to a maximum of 5 doses in a 15-minute window. Additionally, a maximum dose of 40mg of remimazolam (16mL) will be set. Receives: Drug: Remimazolam
Midazolam	Active comparator	Midazolam will be presented as a solution in a 5 mL ampoule. Each ampoule will contain 5 mg of midazolam, yielding a 1 mg/mL solution for injection. Dosing of midazolam was based on local formulary and standard of care / local guidance. An initial dose of 2mg (2mL) over 60 seconds, pausing for 90 seconds, followed by 1mg (1mL) over 30 seconds and waiting 30 seconds will be titrated to response end point. Subsequent doses of 1mg (1 mL) increments can be administered if required should the procedure take longer, or the patient recover more quickly than expected, to maintain the sedation level. Top-up doses will be administered slowly at least 2 minutes apart. Top-up doses will be limited to a maximum of 5 doses in a 15-minute window. Additionally, a maximum of dose of 16mg of midazolam (16mL) will be set. Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

Hopkins Verbal Learning Test Revised (HVLT-R)
The sum of the correct responses in the three learning trials (total recall) following last dose administration of remimazolam or midazolam.
Measured: On day 1. At time T60 (60 minutes after last dose of IMP)

Secondary outcomes (18)

Cognitive and Motor Testing
Proportion of patients returning to within 1 standard error (SE) of pre-dose cognitive and motor testing.
Measured: Baseline and 60 minutes (T60)
Digit Symbol Substitution Test (DSST)
Number of items completed on the digit symbol substitution test (DSST) at baseline and 60 minutes following last dose administration of remimazolam or midazolam
Measured: Baseline and 60 minutes (T60)
Balance Board
Scores on the scales for assessment and rating of ataxia (balance board) at baseline and 60 minutes following last dose administration of remimazolam or midazolam
Measured: Baseline and 60 minutes (T60)
MOART Device
Scores on the reaction time measured on a MOART device by choice reaction time (with Go/No Go) at baseline and 60 minutes following last dose administration of remimazolam or midazolam
Measured: Baseline and 60 minutes (T60)
Start of Procedure
The time to start of procedure (local anaesthetic injection) after administration of the first dose of study medication.
Measured: Time-to-event from IMP administration to start of procedure recorded in minutes between 0 minutes and 20 minutes
Fully Alert After End of Procedure - Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
The times to fully alert (first of three Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of 5 after the end of the procedure (surgical "time out").
Measured: On day 1. Time in minutes between 0 and 90 minutes after defined procedure end.
Fully Alert After Last Injection of Study Drug - Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
The times to fully alert (first of three Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of 5 after the last injection of study drug.
Measured: On day 1. Time in minutes between 0 and 90 minutes after last dose of IMP.
Ready for Discharge After End of Procedure
The times to initial recovery and ready for discharge (passed walk test) after the end of the procedure (surgical "time out").
Measured: On day 1. Time in minutes between 0 and 90 minutes after defined procedure end.
Ready for Discharge After Last Injection of Study Drug
The times to initial recovery and ready for discharge (passed walk test) after the last injection of study drug .
Measured: On day 1. Time in minutes between 0 and 90 minutes after last dose of IMP
Dental Sedation Teachers Group (DSTG) Score
The overall co-operation score given by the surgical team (DSTG score).
The scale is 1 (good) to 4 (impossible), with 1 being the better outcome.
Measured: On day 1. Assessed up to 60 minutes after end of procedure (surgical "time out")
Visual Analogue Score (VAS)
Occurrence of pain on injection at application of study medication (VAS).
The scale is 1-10, with 1 being the better outcome.
Measured: On day 1. Assessed up to 5 minutes after dosing IMP
The Patient Satisfaction Score
The patient satisfaction score
The questionnaire has multiple questions, which the patient will score from 0-10. 10 is the better outcome.
Measured: On day 1 at discharge and repeated on review phone call (minimum on day 3, up to day 10 after procedure)
Requirement for Flumazenil during the Procedure or to Aid Recovery.
The requirement for flumazenil during the procedure or to aid recovery.
Measured: During procedure
Inadequate Sedation
The procedure failure rate due to inadequate sedation at the maximum dose / top-up rate
Measured: During procedure
Comparison of Safety Measures - Hypoxia
Comparison of safety measures - hypoxia (SpO2).
Measured: During Procedure
Comparison of Safety Measures - Airway Manoeuvres
Comparison of safety measures - use of airway manoeuvres.
Measured: During Procedure
Comparison of Safety Measures - Heart Rate
Comparison safety measures - bradycardia \& tachycardia (pulse).
Measured: During Procedure
Comparison of Safety Measures - Blood Pressure
Comparison of safety measures - hypotension and hypertension (NIBP).
Measured: During Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 20221 Sep 2024

First posted2 Feb 2022
Study start9 Mar 2022
Primary completion1 May 2024 (estimated)
Study completion1 Sep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tooth ExtractionStudies of the same condition, open and under way.
More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 128 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05220462
Sponsor's protocol ID: 1003587
Acronym: REMIDENT
Status last verified: Dec 2023
First submitted: 29 Oct 2021
Last updated: 5 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan to share IPD

Want to know more?

Bryan Kerr

02071887188

bryan.kerr@kcl.ac.uk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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All Tooth Extraction trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05220462
Acronym / sponsor ID: REMIDENT / 1003587
Conditions: Tooth Extraction
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 128 participants (estimated)
Lead sponsor: Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
Study start: 9 Mar 2022 (actual)
Primary completion: 1 May 2024 (estimated)
Study completion: 1 Sep 2024 (estimated)
First posted: 2 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The patients will be asked to do will be some questionnaires and some tests which are as follows:

Patients are asked to listen to some words and repeat them back. This tests how well they can remember new information
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.
Symbol test- Patients are asked to draw small shapes that are linked to numbers. This tests how well they can process information.
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Remimazolam	Experimental	Drug: RemimazolamWhite to off-white lyophilised powder, presented in a 12 mL clear glass vial with a grey bromobutyl stopper, fitted with an aluminium crimp and a blue plastic flip-off cap. Each 20 mg vial of remimazolam, will be reconstituted with sterile 0.9% NaCl solution to yield a 2.5 mg/mL solution for injection. An initial dose of 5mg (2mL) over 60 seconds, pausing for 90 seconds, followed by 2.5mg (1mL) over 30 seconds and waiting 30 seconds will be titrated to response end point. Subsequent doses of 2.5mg (1 mL) increments can be administered if required should the procedure take longer, or the patient recover more quickly than expected, to maintain the sedation level. Top-up doses will be administered slowly, at least 2 minutes apart. Top-up doses will be limited to a maximum of 5 doses in a 15-minute window. Additionally, a maximum dose of 40mg of remimazolam (16mL) will be set.
Midazolam	Active comparator	Drug: MidazolamMidazolam will be presented as a solution in a 5 mL ampoule. Each ampoule will contain 5 mg of midazolam, yielding a 1 mg/mL solution for injection. Dosing of midazolam was based on local formulary and standard of care / local guidance. An initial dose of 2mg (2mL) over 60 seconds, pausing for 90 seconds, followed by 1mg (1mL) over 30 seconds and waiting 30 seconds will be titrated to response end point. Subsequent doses of 1mg (1 mL) increments can be administered if required should the procedure take longer, or the patient recover more quickly than expected, to maintain the sedation level. Top-up doses will be administered slowly at least 2 minutes apart. Top-up doses will be limited to a maximum of 5 doses in a 15-minute window. Additionally, a maximum of dose of 16mg of midazolam (16mL) will be set.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RemimazolamAs per Remimazolam arm	Drug	Remimazolam
MidazolamAs per Midazolam arm	Drug	Midazolam

Primary outcome

Hopkins Verbal Learning Test Revised (HVLT-R)
Time frame: On day 1. At time T60 (60 minutes after last dose of IMP)
The sum of the correct responses in the three learning trials (total recall) following last dose administration of remimazolam or midazolam.

18 secondary outcomes

Cognitive and Motor Testing
Time frame: Baseline and 60 minutes (T60)
Digit Symbol Substitution Test (DSST)
Time frame: Baseline and 60 minutes (T60)
Balance Board
Time frame: Baseline and 60 minutes (T60)
MOART Device
Time frame: Baseline and 60 minutes (T60)
Start of Procedure
Time frame: Time-to-event from IMP administration to start of procedure recorded in minutes between 0 minutes and 20 minutes
Fully Alert After End of Procedure - Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
Time frame: On day 1. Time in minutes between 0 and 90 minutes after defined procedure end.
Fully Alert After Last Injection of Study Drug - Modified Observer's Assessment of Alertness/Sedation (MOAA/S)
Time frame: On day 1. Time in minutes between 0 and 90 minutes after last dose of IMP.
Ready for Discharge After End of Procedure
Time frame: On day 1. Time in minutes between 0 and 90 minutes after defined procedure end.
Ready for Discharge After Last Injection of Study Drug
Time frame: On day 1. Time in minutes between 0 and 90 minutes after last dose of IMP
Dental Sedation Teachers Group (DSTG) Score
Time frame: On day 1. Assessed up to 60 minutes after end of procedure (surgical "time out")
Visual Analogue Score (VAS)
Time frame: On day 1. Assessed up to 5 minutes after dosing IMP
The Patient Satisfaction Score
Time frame: On day 1 at discharge and repeated on review phone call (minimum on day 3, up to day 10 after procedure)
Requirement for Flumazenil during the Procedure or to Aid Recovery.
Time frame: During procedure
Inadequate Sedation
Time frame: During procedure
Comparison of Safety Measures - Hypoxia
Time frame: During Procedure
Comparison of Safety Measures - Airway Manoeuvres
Time frame: During Procedure
Comparison of Safety Measures - Heart Rate
Time frame: During Procedure
Comparison of Safety Measures - Blood Pressure
Time frame: During Procedure

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
Individual participant dataSharing planned: No. No plan to share IPD

Related trials for Tooth Extraction

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Active, not recruiting
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Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bryan Kerr contact

02071887188

bryan.kerr@kcl.ac.uk

Bryan Kerr principal investigator

Guy's and St Thomas' NHS Foundation Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remimazolam and Midazolam in people with Tooth Extraction, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bryan Kerr (02071887188, bryan.kerr@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hopkins Verbal Learning Test Revised (HVLT-R) (time frame: On day 1. At time T60 (60 minutes after last dose of IMP)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.