Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients
- Conditions
- RemimazolamSedation ComplicationMidazolam
- Interventions
- Registration Number
- NCT04602845
- Lead Sponsor
- Peking University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- Age 18-60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remimazolam group Flurbiprofen 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. Remimazolam group Fentanyl 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. Midazolam group Midazolam 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. Remimazolam group Remimazolam 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. Midazolam group Fentanyl 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. Midazolam group Flurbiprofen 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.
- Primary Outcome Measures
Name Time Method Success rates of sedation 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.
- Secondary Outcome Measures
Name Time Method Deepest sedation of Bispect ral index(BIS) value Day 0 The lowest intraoperative sedation depth of BIS value
Time to reach ideal sedation Day 0 Time to reach Modified Observer Assessment of Sedation Score (MOAA/S) ≤ 3 after drug administration
Recovery of orientation Day 0 Time from the end of the treatment to the recovery of orientation
Discharge time Day 0 Time to be allowed to discharge after finishing the treatment
Usage rate of flumazenil Day 0 If the patients' MOAA/S less than 4 for more than 15 minutes, flumazenil will be used. The usage rate of flumazenil is the number of patients use flumazenil/ the number of all patients.
Respiratory complication occurrence rate Day 0 Respiratory complication including: intraoperative hypoxemia, respiratory depression and other complications in the two groups.
The Hopkins Language Learning Test score Day 0 The Hopkins Language Learning Test (HVLT-R) score 15 minutes after the end the of the treatment. HVLT-R is a assessment of the patients' language learning condition , this score is from 0 to 30, the more score patients get means the better of patients' Language Learning condition.
Differences in blood pressure between the two groups Day 0 Differences in blood pressure during the operation between the two groups
Differences in heart rate between the two groups Day 0 Differences in heart rate during the operation between the two groups
Differences in basic vital signs between the two groups Day 0 Differences in blood pressure, heart rate, and BIS at different points during the operation between the two groups
Deepest sedation of MOAA/S Day 0 The lowest intraoperative sedation depth of MOAA/S
Benzodiazepine dosage Day 0 Intraoperative benzodiazepine dosage
Trial Locations
- Locations (2)
Peking University Hospital of Stomatology
🇨🇳Beijing, Beijing, China
Zijian Guo
🇨🇳Haidian, Beijing, China