An interventional study of Remimazolam besylate and Midazolam in Dental Anxiety, Sedation Complication and Anterograde Amnesia, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Consenting patients will be eligible if they:
Exclusion Criteria:
Patients will be ineligible if they:
Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.
Drug: Remimazolam besylate
Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.
Drug: Midazolam
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.
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.
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).
Time frame: During treatment in hospital, an expected average of 2 hours
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).
Time frame: During treatment in hospital, an expected average of 2 hours
Interruption reasons during operation
It includes chokes, hypoxia, continuous movement that makes treatment difficult, or other situations requiring suspension of operation.
Time frame: During treatment in hospital, an expected average of 2 hours
Plan to share: Yes — Individual participant dat that underlie the results reported, after deidentification, including texts, tables, figures, and appendices, will be shared as supplementary material.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 3 months and ending 5 years following article publication.
Access criteria: Data will be shared with researchers who provide a methodologically sound proposal.
Started Apr 2022 (actual). Primary completion is estimated for Apr 2023, 11 months after the start.
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Remimazolam besilate
Amnesia, Anterograde
Peking Union Medical College Hospital →