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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
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Benzodiazepines, represented by midazolam, are often used for sedation in outpatient surgery in dentistry. However, midazolam has the problems of slow consciousness recovery and long recovery time, which brings trouble to the patients. Remimazolam is a new type of ultra short acting sedative anesthetic. Compared with other similar products, remimazolam has faster effect, rapid metabolism and has no accumulation, which may mean that compared with midazolam, remimazolam has a better clinical application prospect in dental outpatient surgery.
The patients were randomly divided into midazolam group and remimazolam group. The onset time of drugs, postoperative recovery time, vital signs, anterograde amnesia and other complications were observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Group | Experimental | Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III. |
|
| Midazolam Group | Active Comparator | Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate | Drug | ① initial dose: use a micro injection pump to pump remimazolam at the rate of 50mg/h, and observe for 4 ~ 8 minutes until Ramsay Sedation grade III，then start dental operation ; ② Maintenance dose: maintain the pump speed at 5 ~ 10mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. ④ After the operation, stop the microinjection pump. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time of complete alertness | Calculated from the cessation of sedative injection with micro injection pump, the patients were scored with the modified observer's assessment of alertness/sedation scale (MOAA/S) every 1 minute, and the first minute with MOAA/S score = 5 for 3 consecutive times. MOAA/S score: Range from 5(Awake) to 1(Unresponsive). | During treatment in hospital, an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Anterograde amnesia duration | Patients were given 3 different cards(including animals, fruits, vegetables, vehicles）at 0， 15，30，60 minutes after complete alertness（described at primary outcome). They were asked to recall them immediately and delayed(approximately 5 minutes after Immediate memory). | During treatment in hospital, an expected average of 2 hours |
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Inclusion Criteria:
Consenting patients will be eligible if they:
Exclusion Criteria:
Patients will be ineligible if they:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lijian Pei, MD | Contact | 18612672127 | hazelbeijing@vip.163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41488759 | Derived | Jing Q, Wang W, Wu L, Wang L, Yuan B, Wang Y, Wang C, Liu L, Guan L, Yu R, Zhang Y, Sessler DI, Huang Y, Wan K, Pei L. A Comparison of the Effect of Remimazolam and Midazolam on Recovery and Preserved Memory Function for Patients with Dental Extraction Anxiety. Drug Des Devel Ther. 2025 Dec 30;19:11977-11987. doi: 10.2147/DDDT.S551322. eCollection 2025. | |
| 37185197 |
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Individual participant dat that underlie the results reported, after deidentification, including texts, tables, figures, and appendices, will be shared as supplementary material.
Beginning 3 months and ending 5 years following article publication.
Data will be shared with researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D020324 | Amnesia, Anterograde |
| ID | Term |
|---|---|
| D000647 | Amnesia |
| D008569 | Memory Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Midazolam | Drug | ① initial dose: use a micro injection pump to pump remazolam at the rate of 30mg/h, and observe for 4 ~ 8 minutes until Ramsay Sedation grade III，then start dental operation; ② Maintenance dose: maintain the pump speed at 3 ~ 6mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. ④ After the operation, stop the microinjection pump. |
|
| Interruption reasons during operation | It includes chokes, hypoxia, continuous movement that makes treatment difficult, or other situations requiring suspension of operation. | During treatment in hospital, an expected average of 2 hours |
| Wang L, Jing Q, Pei L, Li M, Ruan X, Chen S, Zhang Y, Wan K, Huang Y. Efficacy of continuous intravenous remimazolam versus midazolam in the extraction of impacted wisdom teeth: protocol of a randomised controlled trial. BMJ Open. 2023 Apr 25;13(4):e067908. doi: 10.1136/bmjopen-2022-067908. |
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |