Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Remimazolam Tosilate Sedation Compared With Midazolam Sedation in Dental Patients: A Double Blind, Prospective , Randomized Controlled Trial

Conditions
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Sedation Complication, Remimazolam, Midazolam

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Flurbiprofen
* Drug: Midazolam
* Drug: Remimazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam group<br>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. | Drug: Fentanyl<br>* 50ug Fentanyl intravenously<br>Drug: Flurbiprofen<br>* 50mg Fentanyl intravenously<br>Drug: Remimazolam<br>* 3mg Remimazolam in 2ml normal saline intravenously<br>|
| Active Comparator: Midazolam group<br>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. | Drug: Fentanyl<br>* 50ug Fentanyl intravenously<br>Drug: Flurbiprofen<br>* 50mg Fentanyl intravenously<br>Drug: Midazolam<br>* 2.5mg midazolam in 2ml normal saline intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rates of sedation | 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. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach ideal sedation | Time to reach Modified Observer Assessment of Sedation Score (MOAA/S) ≤ 3 after drug administration | Day 0 | 
| Differences in blood pressure between the two groups | Differences in blood pressure during the operation between the two groups | Day 0 | 
| Differences in heart rate between the two groups | Differences in heart rate during the operation between the two groups | Day 0 | 
| Differences in basic vital signs between the two groups | Differences in blood pressure, heart rate, and BIS at different points during the operation between the two groups | Day 0 | 
| Deepest sedation of MOAA/S | The lowest intraoperative sedation depth of MOAA/S | Day 0 | 
| Deepest sedation of Bispect ral index(BIS) value | The lowest intraoperative sedation depth of BIS value | Day 0 | 
| Recovery of orientation | Time from the end of the treatment to the recovery of orientation | Day 0 | 
| Benzodiazepine dosage | Intraoperative benzodiazepine dosage | Day 0 | 
| Respiratory complication occurrence rate | Respiratory complication including: intraoperative hypoxemia, respiratory depression and other complications in the two groups. | Day 0 | 
| Discharge time | Time to be allowed to discharge after finishing the treatment | Day 0 | 
| The Hopkins Language Learning Test score | 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. | Day 0 | 
| Usage rate of flumazenil | 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. | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remimazolam, Midazolam, Sedation