Anterograde Amnesia, Dental Anxiety, Sedation Complication
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGRemimazolam besylate
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.
DRUGMidazolam
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.
Sponsors
Beijing Anzhen Hospital
Beijing Shijitan Hospital, Capital Medical University
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Consenting patients will be eligible if they: 1. Have mandibular impacted wisdom teeth that need to be extracted; 2. Have a body mass index (BMI) between 18.5 and 30 kg/m2; 3. Are aged between 18 and 60 years; 4. Have American Society of Anesthesiology (ASA) classification grade of I-II; 5. Have Modified Dental Anxiety Scale (MDAS) score \> 15; and 6. Volunteered to accept intravenous sedation.
Exclusion criteria
Patients will be ineligible if they: 1. Are pregnant; 2. Experience respiratory infections, asthma attack or persistent state; 3. Have contraindications to anaesthesia or a previous abnormal surgical anaesthesia recovery history; 4. Have severe cardiopulmonary insufficiency; 5. Have preoperative blood pressure \> 160/100 mmHg or diastolic blood pressure \> 100 mmHg, or blood pressure \< 90/60 mmHg; 6. Have a neuromuscular or mental disorder that renders them unable to communicate or cooperate effectively or sign informed consent; 7. Are suspected of abusing narcotic analgesics or sedatives; 8. Have a known allergy or contraindication to benzodiazepines; or 9. Have participated in other drug trials within 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery time of complete alertness | During treatment in hospital, an expected average of 2 hours | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anterograde amnesia duration | During treatment in hospital, an expected average of 2 hours | 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). |
| Interruption reasons during operation | During treatment in hospital, an expected average of 2 hours | It includes chokes, hypoxia, continuous movement that makes treatment difficult, or other situations requiring suspension of operation. |
Countries
China
Contacts
Primary ContactLijian Pei, MD
Outcome results
None listed