Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients
NCT ID: NCT04602845
Last Updated: 2022-03-15
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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COMPLETED
PHASE4
81 participants
INTERVENTIONAL
2021-04-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Remimazolam group
Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 3 mg/2ml remimazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Remimazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.
Fentanyl
50ug Fentanyl intravenously
Flurbiprofen
50mg Fentanyl intravenously
Remimazolam
3mg Remimazolam in 2ml normal saline intravenously
Midazolam group
Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 2.5 mg/2ml midazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Midazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.
Fentanyl
50ug Fentanyl intravenously
Flurbiprofen
50mg Fentanyl intravenously
Midazolam
2.5mg midazolam in 2ml normal saline intravenously
Interventions
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Fentanyl
50ug Fentanyl intravenously
Flurbiprofen
50mg Fentanyl intravenously
Midazolam
2.5mg midazolam in 2ml normal saline intravenously
Remimazolam
3mg Remimazolam in 2ml normal saline intravenously
Eligibility Criteria
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Inclusion Criteria
2. BMI in 18-30Kg / m2
3. ASA classification I-II level
4. Sign informed consent
5. Patients whose outpatient treatment time less than 1 hour
6. The methods of local anesthesia including: periosteum infiltration method, periodontal ligament injection method, regional nerve block method
Exclusion Criteria
2. Long-term use of benzodiazepines
3. Long-term use of opioids
4. Participate in other clinical trials within 4 weeks
5. Women during pregnancy or breastfeeding
6. Patients who have a history of drug abuse or long-term alcohol abuse
7. Patients who suffer from mental illness or unable to cooperate with the experiment
18 Years
60 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Yang Xudong
Chief of Department of Anesthesiology
Principal Investigators
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Xudong Yang, MD
Role: STUDY_CHAIR
Department of anesthesiology of peking university school of stomatology
Locations
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Peking University Hospital of Stomatology
Beijing, Beijing Municipality, China
Zijian Guo
Haidian, Beijing Municipality, China
Countries
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Other Identifiers
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PKUSSIRB-202056102
Identifier Type: -
Identifier Source: org_study_id
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