Remimazolam in the Extraction of Impacted Wisdom Teeth

Not Applicable

• Conditions: Dental Anxiety; Sedation Complication; Anterograde Amnesia
• Interventions: Drug: Remimazolam besylate; Drug: Midazolam

• Registration Number: NCT05350085
• Lead Sponsor: Peking Union Medical College Hospital

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, 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.

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 observed.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-10
• Study Start: 2022-04-18
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Primary Completion: 2023-04-01
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam Group	Remimazolam besylate	Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.
Midazolam Group	Midazolam	Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.

Primary Outcome Measures

Name	Time	Method
Recovery time of complete alertness	During treatment in hospital, an expected average of 2 hours	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).

Secondary Outcome Measures

Name	Time	Method
Interruption reasons during operation	During treatment in hospital, an expected average of 2 hours	It includes chokes, hypoxia, continuous movement that makes treatment difficult, or other situations requiring suspension of operation.
Anterograde amnesia duration	During treatment in hospital, an expected average of 2 hours	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).

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China