A Randomized Controlled Clinical Trial of Remimazolam Benzenesulfonate Usage in the Extraction of Impacted Wisdom Teeth
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Recovery time of complete alertness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients will be eligible if they:
- •Have mandibular impacted wisdom teeth that need to be extracted;
- •Have a body mass index (BMI) between 18.5 and 30 kg/m2;
- •Are aged between 18 and 60 years;
- •Have American Society of Anesthesiology (ASA) classification grade of I-II;
- •Have Modified Dental Anxiety Scale (MDAS) score > 15; and
- •Volunteered to accept intravenous sedation.
排除标准
- •Patients will be ineligible if they:
- •Are pregnant;
- •Experience respiratory infections, asthma attack or persistent state;
- •Have contraindications to anaesthesia or a previous abnormal surgical anaesthesia recovery history;
- •Have severe cardiopulmonary insufficiency;
- •Have preoperative blood pressure > 160/100 mmHg or diastolic blood pressure > 100 mmHg, or blood pressure < 90/60 mmHg;
- •Have a neuromuscular or mental disorder that renders them unable to communicate or cooperate effectively or sign informed consent;
- •Are suspected of abusing narcotic analgesics or sedatives;
- •Have a known allergy or contraindication to benzodiazepines; or
- •Have participated in other drug trials within 6 months.
研究组 & 干预措施
Remimazolam Group
Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.
干预措施: Remimazolam besylate (Drug)
Midazolam Group
Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.
干预措施: Midazolam (Drug)
结局指标
主要结局
Recovery time of complete alertness
时间窗: 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).
次要结局
- Interruption reasons during operation(During treatment in hospital, an expected average of 2 hours)
- Anterograde amnesia duration(During treatment in hospital, an expected average of 2 hours)