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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05350085
Other study ID # RBEIWT2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 18, 2022
Est. completion date October 1, 2023

Study information

Verified date April 2022
Source Peking Union Medical College Hospital
Contact Lijian Pei, MD
Phone 18612672127
Email hazelbeijing@vip.163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date October 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: Consenting patients will be eligible if they: 1. Have mandibular impacted wisdom teeth that need to be extracted; 2. Have a body mass index (BMI) between 18.5 and 30 kg/m2; 3. Are aged between 18 and 60 years; 4. Have American Society of Anesthesiology (ASA) classification grade of I-II; 5. Have Modified Dental Anxiety Scale (MDAS) score > 15; and 6. Volunteered to accept intravenous sedation. Exclusion Criteria: Patients will be ineligible if they: 1. Are pregnant; 2. Experience respiratory infections, asthma attack or persistent state; 3. Have contraindications to anaesthesia or a previous abnormal surgical anaesthesia recovery history; 4. Have severe cardiopulmonary insufficiency; 5. Have preoperative blood pressure > 160/100 mmHg or diastolic blood pressure > 100 mmHg, or blood pressure < 90/60 mmHg; 6. Have a neuromuscular or mental disorder that renders them unable to communicate or cooperate effectively or sign informed consent; 7. Are suspected of abusing narcotic analgesics or sedatives; 8. Have a known allergy or contraindication to benzodiazepines; or 9. Have participated in other drug trials within 6 months.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remimazolam besylate
? 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 ; ? Maintenance dose: maintain the pump speed at 5 ~ 10mg/h,adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ? 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. ? After the operation, stop the microinjection pump.
Midazolam
? 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; ? Maintenance dose: maintain the pump speed at 3 ~ 6mg/h,adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ? 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. ? After the operation, stop the microinjection pump.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing

Sponsors (3)

Lead Sponsor Collaborator
Peking Union Medical College Hospital Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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