Remimazolam in the Extraction of Impacted Wisdom Teeth

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Anxiety; Sedation Complication; Anterograde Amnesia
• Intervention / Treatment: Drug: Remimazolam besylate; Drug: Midazolam

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam Group; Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.	Drug: Remimazolam besylate; 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.
Active Comparator: Midazolam Group; Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III.	Drug: Midazolam; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Memory Disorders; Amnesia; Amnesia, Anterograde; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: RBEIWT2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant dat that underlie the results reported, after deidentification, including texts, tables, figures, and appendices, will be shared as supplementary material.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No