Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for Dental Extractions.
NCT ID: NCT05220462
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
128 participants
INTERVENTIONAL
2022-03-09
2024-09-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Remimazolam
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.
Remimazolam
As per Remimazolam arm
Midazolam
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.
Midazolam
As per Midazolam arm
Interventions
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Remimazolam
As per Remimazolam arm
Midazolam
As per Midazolam arm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
59 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Bryan Kerr
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Bryan Kerr
Role: primary
Other Identifiers
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1003587
Identifier Type: -
Identifier Source: org_study_id