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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
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.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGRecovery 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
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