RemimazolamPhase 4NCT05340335
ED90 of Remimazolam Loading Dose for Sedation in Patients Under Monitored Anesthetic Care
A Phase 4 study testing Remimazolam in people with Remimazolam and Orthopedic Procedures, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Remimazolam, Orthopedic Procedures, Sedatives
- What is being tested?
- Remimazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Apr 2022to 2 May 2022
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA PS 1-3
- Patients who are scheduled to undergo upper/lower limb surgery under the monitored anesthetic care with remimazolam
Who cannot join
- Patients who refuse to participate in this study
- Patients with hypersensitivity to benzodiazepine or flumazenil
- Patients with severe renal/hepatic disease
- Patients with drug/alcohol abuse
- Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
- Patients with difficulty in communication
Show all 9Show fewer
- Patients with severe obstructive sleep apnea or other airway problems
- Patients contraindicated to regional anesthesia
- Patients judged to be inappropriate for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effective Dose 90 of Remimazolam Loading Dose for Adequate Sedation in Patients Undergoing Orthopaedic Surgery Under Monitored Anesthetic Care
Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the effect disappeared very quickly due to the short context-sensitive half time. nd through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the effect of flumazenil suggest that remimazolam can be used effectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the effective infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established.
In this study, the ED90 of the loading dose to induce loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of Remimazolam is to be obtained.
- Conditions
- Remimazolam, Orthopedic Procedures, Sedatives
- Being tested
- Remimazolam
- Keywords
- remimazolam, sedative effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
A beginning dose of remimazolam is 1mg/kg/hr. When sedation is not achieved in 10 minutes, the dose will be increased by 0.1mg/kg/hr in the next patient. When sedation is successful, the same dose will be used with the probability of 0.89, or the dose will be decreased by 0.1mg/kg/hr with the probability of 0.11 in the next patient. (maximal dose: 2mg/kg/hr)
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | A loading dose of remimazolam is administered for sedation Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether sedation was successful
MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)
Measured: for 10 minutes from the initiation of the remimazolam administration
Secondary outcomes (2)
Total amount of remimazolam for sedation
MOAA/S score of 3 or less
Measured: From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes
Effect site concentration
Calculated by a computerized program(Asanpump)
Measured: From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start18 Apr 2022
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
- Investigators
- Ha-Jung Kim, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340335
- Sponsor's protocol ID
- S2021-2407-0002
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim HJ, Kim H, Park HS, Kim HJ, Ro YJ, Koh WU. Effective remimazolam loading dose for adequate sedation in regional anesthesia. Can J Anaesth. 2024 Jun;71(6):818-825. doi: 10.1007/s12630-024-02698-1. Epub 2024 Feb 20.
PubMed 38378937
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effective Dose 90 of Remimazolam Loading Dose for Adequate Sedation in Patients Undergoing Orthopaedic Surgery Under Monitored Anesthetic Care
- ClinicalTrials.gov ID
- NCT05340335
- Acronym / sponsor ID
- S2021-2407-0002
- Conditions
- Remimazolam, Orthopedic Procedures, Sedatives
- Keywords
- remimazolam, sedative effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 22 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.
Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the effect disappeared very quickly due to the short context-sensitive half time. nd through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the effect of flumazenil suggest that remimazolam can be used effectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the effective infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established.
In this study, the ED90 of the loading dose to induce loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of Remimazolam is to be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: RemimazolamA loading dose of remimazolam is administered for sedation |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA PS 1-3
- Patients who are scheduled to undergo upper/lower limb surgery under the monitored anesthetic care with remimazolam
Key exclusion criteria (9 listed)
- Patients who refuse to participate in this study
- Patients with hypersensitivity to benzodiazepine or flumazenil
- Patients with severe renal/hepatic disease
- Patients with drug/alcohol abuse
- Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
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 |
|---|---|---|
| RemimazolamA beginning dose of remimazolam is 1mg/kg/hr. When sedation is not achieved in 10 minutes, the dose will be increased by 0.1mg/kg/hr in the next patient. When sedation is successful, the same dose will be used with the probability of 0.89, or the dose will be decreased by 0.1mg/kg/hr with the probability of 0.11 in the next patient. (maximal dose: 2mg/kg/hr) | Drug | Remimazolam |
Primary outcome
Whether sedation was successful
Time frame: for 10 minutes from the initiation of the remimazolam administration
MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)
2 secondary outcomes
Total amount of remimazolam for sedation
Time frame: From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes
Effect site concentration
Time frame: From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes
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 21 Jul 2022.
- Derived from this study: PubMed 38378937Kim HJ, Kim H, Park HS, Kim HJ, Ro YJ, Koh WU. Effective remimazolam loading dose for adequate sedation in regional anesthesia. Can J Anaesth. 2024 Jun;71(6):818-825. doi: 10.1007/s12630-024-02698-1. Epub 2024 Feb 20.
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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.
Ha-Jung Kim principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam in people with Remimazolam and Orthopedic Procedures, run by Asan Medical Center at 1 site in South Korea.
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 2 inclusion and 9 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 21 Jul 2022. 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 South Korea. 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?
Whether sedation was successful (time frame: for 10 minutes from the initiation of the remimazolam administration). 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 NCT05340335, which also lists 1 linked publication.
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 21 Jul 2022.