Sedation ComplicationPhase 4NCT04602845
Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients
A Phase 4 study testing Fentanyl, Flurbiprofen and Midazolam in people with Sedation Complication and Midazolam, run by Peking University at 2 sites in China.
Trial summary
Remimazolam Tosilate is a new short-acting benzodiazepines used in sedation. It has the advantages of rapid metabolism, quick recovery without injection pain. This study aims to compared with Midazolam, study whether Remimazolam Tosilate can achieve the same sedation effect with lower side effects on sedation… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sedation Complication, Midazolam, Remimazolam
- What is being tested?
- Fentanyl, Flurbiprofen and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2021to 31 Dec 2021
- Phase
- Phase 4
- 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
- Age 18-60
- BMI in 18-30Kg / m2
- ASA classification I-II level
- Sign informed consent
- Patients whose outpatient treatment time less than 1 hour
- The methods of local anesthesia including: periosteum infiltration method, periodontal ligament injection method, regional nerve block method
Who cannot join
- Patients who are allergic to benzodiazepines, opioids, flumazenil or have contraindications
- Long-term use of benzodiazepines
- Long-term use of opioids
- Participate in other clinical trials within 4 weeks
- Women during pregnancy or breastfeeding
- Patients who have a history of drug abuse or long-term alcohol abuse
- Patients who suffer from mental illness or unable to cooperate with the experiment
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University Hospital of Stomatology
Beijing, Beijing Municipality, 100081
Zijian Guo
Haidian, Beijing Municipality, 100081
About this study
Official title: The Effects of Remimazolam Tosilate Sedation Compared With Midazolam Sedation in Dental Patients: A Double Blind, Prospective , Randomized Controlled Trial
Remimazolam Tosilate is a new short-acting benzodiazepines used in sedation. It has the advantages of rapid metabolism, quick recovery without injection pain. This study aims to compared with Midazolam, study whether Remimazolam Tosilate can achieve the same sedation effect with lower side effects on sedation maintenance period, During the recovery period of anesthesia, can Remimazolam Tosilatebe more stable and rapid.
- Conditions
- Sedation Complication, Midazolam, Remimazolam
- Keywords
- Remimazolam, Midazolam, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
50ug Fentanyl intravenously
FlurbiprofenDrug
50mg Fentanyl intravenously
MidazolamDrug
2.5mg midazolam in 2ml normal saline intravenously
RemimazolamDrug
3mg Remimazolam in 2ml normal saline intravenously
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 3 mg/2ml remimazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Remimazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation. Receives: Drug: Fentanyl; Drug: Flurbiprofen; Drug: Remimazolam |
| Midazolam group | Active comparator | Drug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 2.5 mg/2ml midazolam.
Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Midazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation. Receives: Drug: Fentanyl; Drug: Flurbiprofen; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rates of sedation
Success rates for patients who completed outpatient treatment with sufficient depth of sedation, additional sedation medication less than 5 times /15 minutes, and without the need of propofol for further sedation.
Measured: Day 0
Secondary outcomes (12)
Time to reach ideal sedation
Time to reach Modified Observer Assessment of Sedation Score (MOAA/S) ≤ 3 after drug administration
Measured: Day 0
Differences in blood pressure between the two groups
Differences in blood pressure during the operation between the two groups
Measured: Day 0
Differences in heart rate between the two groups
Differences in heart rate during the operation between the two groups
Measured: Day 0
Differences in basic vital signs between the two groups
Differences in blood pressure, heart rate, and BIS at different points during the operation between the two groups
Measured: Day 0
Deepest sedation of MOAA/S
The lowest intraoperative sedation depth of MOAA/S
Measured: Day 0
Deepest sedation of Bispect ral index(BIS) value
The lowest intraoperative sedation depth of BIS value
Measured: Day 0
Recovery of orientation
Time from the end of the treatment to the recovery of orientation
Measured: Day 0
Benzodiazepine dosage
Intraoperative benzodiazepine dosage
Measured: Day 0
Respiratory complication occurrence rate
Respiratory complication including: intraoperative hypoxemia, respiratory depression and other complications in the two groups.
Measured: Day 0
Discharge time
Time to be allowed to discharge after finishing the treatment
Measured: Day 0
The Hopkins Language Learning Test score
The Hopkins Language Learning Test (HVLT-R) score 15 minutes after the end the of the treatment. HVLT-R is a assessment of the patients' language learning condition , this score is from 0 to 30, the more score patients get means the better of patients' Language Learning condition.
Measured: Day 0
Usage rate of flumazenil
If the patients' MOAA/S less than 4 for more than 15 minutes, flumazenil will be used. The usage rate of flumazenil is the number of patients use flumazenil/ the number of all patients.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Apr 2021
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation ComplicationStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xudong, Peking University
- Investigators
- Xudong Yang, MD, Study chair, Department of anesthesiology of peking university school of stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602845
- Sponsor's protocol ID
- PKUSSIRB-202056102
- Status last verified
- Mar 2022
- First submitted
- 10 Sep 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Remimazolam Tosilate Sedation Compared With Midazolam Sedation in Dental Patients: A Double Blind, Prospective , Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04602845
- Acronym / sponsor ID
- PKUSSIRB-202056102
- Conditions
- Sedation Complication, Midazolam, Remimazolam
- Keywords
- Remimazolam, Midazolam, Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Oct 2020 (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.
Remimazolam Tosilate is a new short-acting benzodiazepines used in sedation. It has the advantages of rapid metabolism, quick recovery without injection pain. This study aims to compared with Midazolam, study whether Remimazolam Tosilate can achieve the same sedation effect with lower side effects on sedation maintenance period, During the recovery period of anesthesia, can Remimazolam Tosilatebe more stable and rapid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: Fentanyl, Drug: Flurbiprofen, Drug: RemimazolamDrug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 3 mg/2ml remimazolam. Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Remimazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation. |
| Midazolam group | Active comparator | Drug: Fentanyl, Drug: Flurbiprofen, Drug: MidazolamDrug administration: 50ug fentanyl and 50mg flurbiprofen at the beginning of induction and pre-prepared drugs labeled "inducers", which contained 2.5 mg/2ml midazolam. Successful sedation is defined as MOAA/S score less than or equal to 4 points during the whole process of the treatment. If MOAA/S score was greater than 4 points, a single dose of Midazolam (1 mg) is allowed to deepen sedation. if three times of deepen sedation within 15 minutes still can not achieve successful sedation, this progress will define as failure sedation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60
- BMI in 18-30Kg / m2
- ASA classification I-II level
- Sign informed consent
- Patients whose outpatient treatment time less than 1 hour
Key exclusion criteria (7 listed)
- Patients who are allergic to benzodiazepines, opioids, flumazenil or have contraindications
- Long-term use of benzodiazepines
- Long-term use of opioids
- Participate in other clinical trials within 4 weeks
- Women during pregnancy or breastfeeding
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 |
|---|---|---|
| Fentanyl50ug Fentanyl intravenously | Drug | Midazolam group, Remimazolam group |
| Flurbiprofen50mg Fentanyl intravenously | Drug | Midazolam group, Remimazolam group |
| Midazolam2.5mg midazolam in 2ml normal saline intravenously | Drug | Midazolam group |
| Remimazolam3mg Remimazolam in 2ml normal saline intravenously | Drug | Remimazolam group |
Primary outcome
Success rates of sedation
Time frame: Day 0
Success rates for patients who completed outpatient treatment with sufficient depth of sedation, additional sedation medication less than 5 times /15 minutes, and without the need of propofol for further sedation.
12 secondary outcomes
Time to reach ideal sedation
Time frame: Day 0
Differences in blood pressure between the two groups
Time frame: Day 0
Differences in heart rate between the two groups
Time frame: Day 0
Differences in basic vital signs between the two groups
Time frame: Day 0
Deepest sedation of MOAA/S
Time frame: Day 0
Deepest sedation of Bispect ral index(BIS) value
Time frame: Day 0
Recovery of orientation
Time frame: Day 0
Benzodiazepine dosage
Time frame: Day 0
Respiratory complication occurrence rate
Time frame: Day 0
Discharge time
Time frame: Day 0
The Hopkins Language Learning Test score
Time frame: Day 0
Usage rate of flumazenil
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Xudong Yang, MD study chair
Department of anesthesiology of peking university school of stomatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl, Flurbiprofen and Midazolam in people with Sedation Complication and Midazolam, run by Peking University at 2 sites 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rates of sedation (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2022.