Remimazolam in the Extraction of Impacted Wisdom Teeth

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Randomized Controlled Clinical Trial of Remimazolam Benzenesulfonate Usage in the Extraction of Impacted Wisdom Teeth

Conditions
-----------------
Dental Anxiety, Sedation Complication, Anterograde Amnesia

Intervention / Treatment
-----------------
* Drug: Remimazolam besylate
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam Group<br>Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III. | Drug: Remimazolam besylate<br>* ① initial dose: use a micro injection pump to pump remimazolam at the rate of 50mg/h, and observe for 4   8 minutes until Ramsay Sedation grade III，then start dental operation ; ② Maintenance dose: maintain the pump speed at 5   10mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. ④ After the operation, stop the microinjection pump.<br>|
| Active Comparator: Midazolam Group<br>Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III. | Drug: Midazolam<br>* ① initial dose: use a micro injection pump to pump remazolam at the rate of 30mg/h, and observe for 4   8 minutes until Ramsay Sedation grade III，then start dental operation; ② Maintenance dose: maintain the pump speed at 3   6mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ Additional dose: During the operation, if the patient has body movement reaction or cannot cooperate with the dentist, local anesthetics shall be given as remedy. ④ After the operation, stop the microinjection pump.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |