SedativePhase 4NCT05468996
Median Effective Dose of Remimazolam for Sedation in Elderly Patients
A Phase 4 study testing Remimazolam in people with Sedative, 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 20 years and older
- Conditions the study is for
- Sedative
- What is being tested?
- Remimazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2022to 28 Oct 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: equal or older than 20 years
- ASA PS: 1-3
- patients who are scheduled to undergo lower limb surgery under spinal anesthesia with sedation using 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: Median Effective Dose of Remimazolam for Sedation in Elderly Patients Undergoing Lower Limb Surgery Under Spinal Anesthesia
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. And 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 maintenance dose of remimazolam for sedation without mechanical ventilation has not been established. In addition, age might be an important factor for determining the appropriate dose of remimazolam.
In this study, we aim to identify the median effective dose of remimazolam for maintaining sedation in elderly patients undergoing lower limb surgery under spinal anesthesia.
- Conditions
- Sedative
- Being tested
- Remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
A loading dose of remimazolam is 1mg/kg/hr. When sedation is achieved, the dose of remimazolam is adjusted to the assigned dose. The maintenance dose of remimazolam begins at 1.0mg/kg/hr. When the maintenance is not successful during the surgery, the maintenance dose will be increased by 0.1-0.2mg/kg/hr in the next patient. When the maintenance is successful, the dose will be decreased by 0.1-0.2mg/kg/hr. (maximal dose: 2mg/kg/hr)
| Study group | Role | What they receive |
|---|---|---|
| young-old group | Active comparator | a group of patients who are 60 to 74 years old Receives: Drug: Remimazolam |
| old-old group | Active comparator | a group of patients who are equal or older than 75 years Receives: Drug: Remimazolam |
| young adult group | Active comparator | a group of patients who are 20-59 years old Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
success or failure of sedation maintenance
MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)
Measured: throughout the surgery
Secondary outcomes (1)
respiratory depression
respiratory rate equal or less than 6 time per minute
Measured: throughout the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start10 May 2022
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedativeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Uk, Koh, Asan Medical Center
- Investigators
- Won Uk Koh, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468996
- Sponsor's protocol ID
- 2021-1869
- Status last verified
- Apr 2023
- First submitted
- 12 May 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Median Effective Dose of Remimazolam for Sedation in Elderly Patients Undergoing Lower Limb Surgery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05468996
- Acronym / sponsor ID
- 2021-1869
- Conditions
- Sedative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 21 Jul 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. And 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 maintenance dose of remimazolam for sedation without mechanical ventilation has not been established. In addition, age might be an important factor for determining the appropriate dose of remimazolam.
In this study, we aim to identify the median effective dose of remimazolam for maintaining sedation in elderly patients undergoing lower limb surgery under spinal anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| young-old group | Active comparator | Drug: Remimazolama group of patients who are 60 to 74 years old |
| old-old group | Active comparator | Drug: Remimazolama group of patients who are equal or older than 75 years |
| young adult group | Active comparator | Drug: Remimazolama group of patients who are 20-59 years old |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age: equal or older than 20 years
- ASA PS: 1-3
- patients who are scheduled to undergo lower limb surgery under spinal anesthesia with sedation using 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 loading dose of remimazolam is 1mg/kg/hr. When sedation is achieved, the dose of remimazolam is adjusted to the assigned dose. The maintenance dose of remimazolam begins at 1.0mg/kg/hr. When the maintenance is not successful during the surgery, the maintenance dose will be increased by 0.1-0.2mg/kg/hr in the next patient. When the maintenance is successful, the dose will be decreased by 0.1-0.2mg/kg/hr. (maximal dose: 2mg/kg/hr) | Drug | old-old group, young adult group, young-old group |
Primary outcome
success or failure of sedation maintenance
Time frame: throughout the surgery
MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)
1 secondary outcome
respiratory depression
Time frame: throughout the surgery
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 Apr 2023.
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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.
Won Uk Koh 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 Sedative, 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 3 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 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 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?
success or failure of sedation maintenance (time frame: throughout the surgery). 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 21 Apr 2023.