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Remimazolam Tosilate is a new short-acting benzodiazepines used in sedation. It has the advantages of rapid metabolism, quick recovery without injection pain. This study aims to compared with Midazolam, study whether Remimazolam Tosilate can achieve the same sedation effect with lower side effects on sedation maintenance period, During the recovery period of anesthesia, can Remimazolam Tosilatebe more stable and rapid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental | 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. |
|
| Midazolam group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | 50ug Fentanyl intravenously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Success rates of sedation | Success rates for patients who completed outpatient treatment with sufficient depth of sedation, additional sedation medication less than 5 times /15 minutes, and without the need of propofol for further sedation. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach ideal sedation | Time to reach Modified Observer Assessment of Sedation Score (MOAA/S) ≤ 3 after drug administration | Day 0 |
| Differences in blood pressure between the two groups | Differences in blood pressure during the operation between the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xudong Yang, MD | Department of anesthesiology of peking university school of stomatology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Hospital of Stomatology | Beijing | Beijing Municipality | 100081 | China | ||
| Zijian Guo |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D005480 | Flurbiprofen |
| D008874 | Midazolam |
| C522201 | remimazolam |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
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| Flurbiprofen |
| Drug |
50mg Fentanyl intravenously |
|
| Midazolam | Drug | 2.5mg midazolam in 2ml normal saline intravenously |
|
| Remimazolam | Drug | 3mg Remimazolam in 2ml normal saline intravenously |
|
| Day 0 |
| Differences in heart rate between the two groups | Differences in heart rate during the operation between the two groups | Day 0 |
| Differences in basic vital signs between the two groups | Differences in blood pressure, heart rate, and BIS at different points during the operation between the two groups | Day 0 |
| Deepest sedation of MOAA/S | The lowest intraoperative sedation depth of MOAA/S | Day 0 |
| Deepest sedation of Bispect ral index(BIS) value | The lowest intraoperative sedation depth of BIS value | Day 0 |
| Recovery of orientation | Time from the end of the treatment to the recovery of orientation | Day 0 |
| Benzodiazepine dosage | Intraoperative benzodiazepine dosage | Day 0 |
| Respiratory complication occurrence rate | Respiratory complication including: intraoperative hypoxemia, respiratory depression and other complications in the two groups. | Day 0 |
| Discharge time | Time to be allowed to discharge after finishing the treatment | Day 0 |
| The Hopkins Language Learning Test score | The Hopkins Language Learning Test (HVLT-R) score 15 minutes after the end the of the treatment. HVLT-R is a assessment of the patients' language learning condition , this score is from 0 to 30, the more score patients get means the better of patients' Language Learning condition. | Day 0 |
| Usage rate of flumazenil | If the patients' MOAA/S less than 4 for more than 15 minutes, flumazenil will be used. The usage rate of flumazenil is the number of patients use flumazenil/ the number of all patients. | Day 0 |
| Haidian |
| Beijing Municipality |
| 100081 |
| China |
| D000144 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |