Remimazolam in the Extraction of Impacted Wisdom Teeth

April 5, 2023 updated by: Peking Union Medical College Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recovery time of complete alertness
Time Frame: 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).
During treatment in hospital, an expected average of 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anterograde amnesia duration
Time Frame: 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).
During treatment in hospital, an expected average of 2 hours
Interruption reasons during operation
Time Frame: 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.
During treatment in hospital, an expected average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Shijitan Hospital, Capital Medical University
Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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