Status:
UNKNOWN
Remimazolam in the Extraction of Impacted Wisdom Teeth
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Anzhen Hospital
Beijing Shijitan Hospital, Capital Medical University
Conditions:
Dental Anxiety
Sedation Complication
Eligibility:
All Genders
18-60 years
Phase:
NA
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, wh...
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 obser...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05350085
Start Date
April 18 2022
End Date
October 1 2023
Last Update
April 7 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China