Remimazolam in the Extraction of Impacted Wisdom Teeth

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Dental Anxiety; Sedation Complication; Anterograde Amnesia

Treatments: Drug: Remimazolam besylate; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05350085

RBEIWT2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Remimazolam Group

Experimental group

Description:

Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.

Treatment:

Drug: Remimazolam besylate

Midazolam Group

Active Comparator group

Description:

Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.

Treatment:

Drug: Midazolam