Dental Anxiety Clinical Trial
Official title:
A Randomized Controlled Clinical Trial of Remimazolam Benzenesulfonate Usage in the Extraction of Impacted Wisdom Teeth
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | October 1, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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