Dental AnxietyNCT05350085
Remimazolam in the Extraction of Impacted Wisdom Teeth
A study testing Remimazolam besylate and Midazolam in people with Dental Anxiety and Sedation Complication, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dental Anxiety, Sedation Complication, Anterograde Amnesia
- What is being tested?
- Remimazolam besylate and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Lijian Pei, MD, 18612672127, hazelbeijing@vip.163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Anxiety, Sedation Complication, Anterograde Amnesia
- Being tested
- Remimazolam besylate, Midazolam
- Medical subject headings
- Amnesia, Anterograde
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
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.
MidazolamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Group | Experimental | Use remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III. Receives: Drug: Remimazolam besylate |
| Midazolam Group | Active comparator | Use midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During treatment in hospital, an expected average of 2 hours
Secondary outcomes (2)
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).
Measured: 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.
Measured: During treatment in hospital, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start18 Apr 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350085
- Sponsor's protocol ID
- RBEIWT2022
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant dat that underlie the results reported, after deidentification, including texts, tables, figures, and appendices, will be shared as supplementary material.
Publications
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.
PubMed 41488759Wang 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.
PubMed 37185197
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Remimazolam Benzenesulfonate Usage in the Extraction of Impacted Wisdom Teeth
- ClinicalTrials.gov ID
- NCT05350085
- Acronym / sponsor ID
- RBEIWT2022
- Conditions
- Dental Anxiety, Sedation Complication, Anterograde Amnesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Beijing Shijitan Hospital, Capital Medical University
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Group | Experimental | Drug: Remimazolam besylateUse remimazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III. |
| Midazolam Group | Active comparator | Drug: MidazolamUse midazolam as sedation.Sufficient sedation is defined as Ramsay Sedation score grade III. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam besylate① 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. | Drug | Remimazolam Group |
| Midazolam① 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. | Drug | Midazolam Group |
Primary outcome
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).
2 secondary outcomes
Anterograde amnesia duration
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Derived from this study: PubMed 41488759Jing 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.
- Derived from this study: PubMed 37185197Wang 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.
- Individual participant dataSharing planned: Yes. Individual participant dat that underlie the results reported, after deidentification, including texts, tables, figures, and appendices, will be shared as supplementary material.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam besylate and Midazolam in people with Dental Anxiety and Sedation Complication, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lijian Pei, MD (18612672127, hazelbeijing@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time of complete alertness (time frame: During treatment in hospital, an expected average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.