The Effects of Remimazolam Tosilate Sedation Compared With Midazolam Sedation in Dental Patients: A Double Blind, Prospective , Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Success rates of sedation
研究概览
简要总结
Remimazolam Tosilate is a new short-acting benzodiazepines used in sedation. It has the advantages of rapid metabolism, quick recovery without injection pain. This study aims to compared with Midazolam, study whether Remimazolam Tosilate can achieve the same sedation effect with lower side effects on sedation maintenance period, During the recovery period of anesthesia, can Remimazolam Tosilatebe more stable and rapid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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
- •BMI in 18-30Kg / m2
- •ASA classification I-II level
- •Sign informed consent
- •Patients whose outpatient treatment time less than 1 hour
- •The methods of local anesthesia including: periosteum infiltration method, periodontal ligament injection method, regional nerve block method
排除标准
- •Patients who are allergic to benzodiazepines, opioids, flumazenil or have contraindications
- •Long-term use of benzodiazepines
- •Long-term use of opioids
- •Participate in other clinical trials within 4 weeks
- •Women during pregnancy or breastfeeding
- •Patients who have a history of drug abuse or long-term alcohol abuse
- •Patients who suffer from mental illness or unable to cooperate with the experiment
研究组 & 干预措施
Remimazolam group
Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 3 mg/2ml remimazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Remimazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.
干预措施: Fentanyl (Drug)
Remimazolam group
Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 3 mg/2ml remimazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Remimazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.
干预措施: Flurbiprofen (Drug)
Remimazolam group
Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 3 mg/2ml remimazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Remimazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.
干预措施: Remimazolam (Drug)
Midazolam group
Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 2.5 mg/2ml midazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Midazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.
干预措施: Fentanyl (Drug)
Midazolam group
Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 2.5 mg/2ml midazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Midazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.
干预措施: Flurbiprofen (Drug)
Midazolam group
Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 2.5 mg/2ml midazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Midazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation.
干预措施: Midazolam (Drug)
结局指标
主要结局
Success rates of sedation
时间窗: Day 0
Success rates for patients who completed outpatient treatment with sufficient depth of sedation, additional sedation medication less than 5 times /15 minutes, and without the need of propofol for further sedation.
次要结局
- Deepest sedation of Bispect ral index(BIS) value(Day 0)
- Time to reach ideal sedation(Day 0)
- Recovery of orientation(Day 0)
- Discharge time(Day 0)
- Usage rate of flumazenil(Day 0)
- Respiratory complication occurrence rate(Day 0)
- The Hopkins Language Learning Test score(Day 0)
- Differences in blood pressure between the two groups(Day 0)
- Differences in heart rate between the two groups(Day 0)
- Differences in basic vital signs between the two groups(Day 0)
- Deepest sedation of MOAA/S(Day 0)
- Benzodiazepine dosage(Day 0)
研究者
Yang Xudong
Chief of Department of Anesthesiology
Peking University