Remimazolam in the Extraction of Impacted Wisdom Teeth

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05350085
• Other study ID #: RBEIWT2022
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Amnesia
• Dental Anxiety
• Sedation Complication

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