Remazolam Besylate in the Extraction of Impacted Wisdom Teeth

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Benzodiazepines, represented by midazolam, are often used for sedation in outpatient surgery in stomatology. However, midazolam has the problems of slow consciousness recovery and long recovery time, which brings trouble to the patients. Remazolam besylate is a new type of ultra short acting sedative anesthetic. Compared with other similar products, remazolam besylate has faster effect, rapid metabolism and has no accumulation, which may mean that compared with midazolam, remazolam besylate has a better clinical application prospect in outpatient surgery in stomatology.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Anzhen Hospital; Beijing Shijitan Hospital, Capital Medical University
• Treatments: Midazolam

Criteria

Inclusion Criteria:

1. Have mandibular impacted wisdom teeth need to be extracted;

2. Body mass index (BMI) between 18.5 and 30 kg/m2;

3. 18-60 years old;

4. The American Society of Anesthesiologists (ASA) is classified as grade I ~ II;

5. Voluntary dental comfort care;

6. Voluntary participation and signed informed consent.

Exclusion Criteria:

1. Suffer from respiratory tract infection, asthma attack and persistent state;

2. Have contraindications to anesthesia or previous abnormal surgical anesthesia recovery history;

3. Have severe cardiopulmonary diseases (such as severe ECG abnormalities and cardiopulmonary insufficiency);

4. Preoperative blood pressure > 160/100mmHg or diastolic blood pressure > 100mmHg, or blood pressure < 90/60mmHg;

5. Have serious intraoperative complications due to potential or combined diseases (such as family history of malignant hyperthermia);

6. Have neuromuscular diseases, mental diseases or unable to communicate effectively and do not cooperate;

7. Suspected of abusing narcotic analgesics or sedatives;

8. Known allergy to benzodiazepines or contraindication;

9. Participated in other drug trials within six months.