Remimazolam in the Extraction of Impacted Wisdom Teeth

NCT05350085 | Unknown

• 1 other identifier: RBEIWT2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety; Sedation Complication; Anterograde Amnesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anterograde amnesia duration

  During treatment in hospital, an expected average of 2 hours

• Interruption reasons during operation

  During treatment in hospital, an expected average of 2 hours

Study Arms (2)

Remimazolam Group

EXPERIMENTAL

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

Drug: Remimazolam besylate

Midazolam Group

ACTIVE COMPARATOR

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

Drug: Midazolam

Interventions

Remimazolam besylate DRUG

① 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 ; ② Maintenance dose: maintain the pump speed at 5 \~ 10mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ 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. ④ After the operation, stop the microinjection pump.

Remimazolam Group

Midazolam DRUG

① 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; ② Maintenance dose: maintain the pump speed at 3 \~ 6mg/h，adjust the pump dose to maintain the patient at Ramsay Sedation grade III. ③ 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. ④ After the operation, stop the microinjection pump.

Midazolam Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Anzhen Hospital: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (2)

• Jing Q, Wang W, Wu L, Wang L, Yuan B, Wang Y, Wang C, Liu L, Guan L, Yu R, Zhang Y, Sessler DI, Huang Y, Wan K, Pei L. A Comparison of the Effect of Remimazolam and Midazolam on Recovery and Preserved Memory Function for Patients with Dental Extraction Anxiety. Drug Des Devel Ther. 2025 Dec 30;19:11977-11987. doi: 10.2147/DDDT.S551322. eCollection 2025.

  PMID: 41488759 DERIVED

• Wang L, Jing Q, Pei L, Li M, Ruan X, Chen S, Zhang Y, Wan K, Huang Y. Efficacy of continuous intravenous remimazolam versus midazolam in the extraction of impacted wisdom teeth: protocol of a randomised controlled trial. BMJ Open. 2023 Apr 25;13(4):e067908. doi: 10.1136/bmjopen-2022-067908.

  PMID: 37185197 DERIVED

MeSH Terms

Conditions

Amnesia, Anterograde

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Amnesia; Memory Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Lijian Pei, MD

CONTACT

18612672127; hazelbeijing@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 27, 2022
• Study Start: April 18, 2022
• Primary Completion: April 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 7, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal.

Locations

CN (1)