RemimazolamNCT05512559
Body Composition Analysis and Time to Emergence From Remimazolam
An observational study of Remimazolam and Body Composition, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Remimazolam is a novel general anesthetic drug. The time to emergence from remimazolam-based general anesthesia is variable among patients, but little is known about the risk factors for delayed emergence. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Remimazolam, Body Composition
- What is being tested?
- body composition analysis
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Sep 2022to Mar 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam
Who may be able to join
- Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam
Who cannot join
- Patients with preoperative mental change, hemodynamic instability, hemodialysis, heart failure, hypoalbuminemia, pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University, School of Medicine
Seoul, 06351
About this study
Official title: Value of Body Composition Analysis in Predicting Delayed Emergence From Remimazolam-based General Anesthesia: A Prospective Observational Study.
Remimazolam is a novel general anesthetic drug. The time to emergence from remimazolam-based general anesthesia is variable among patients, but little is known about the risk factors for delayed emergence. We believe that information from body composition analysis may be helpful in understanding which patients are more likely to show delayed emergence from remimazolam.
- Conditions
- Remimazolam, Body Composition
- Being tested
- body composition analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body composition analysisDevice
Body composition analysis by bioelectrical impedance measurement, just before induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| remimazolam | general anesthesia induction with 6mg/kg/hr continuous infusion of remimazolam. general anesthesia maintenance with 1mg/kg/hr continuous infusion of remimazolam. Receives: Device: body composition analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
emergence time
relationship between body composition analysis information and time to emergence after discontinuing remimazolam infusion.
Measured: at the time of emergence
Secondary outcomes (2)
time to loss of consciousness
relationship between body composition analysis information and time to loss of consciousness after starting remimazolam infusion.
Measured: at the time of induction
hypotension
relationship between body composition analysis information and hypotensive event during anesthesia
Measured: from induction to emergence of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start5 Sep 2022
- Primary completion30 Dec 2022
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- More trials run by Samsung 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512559
- Sponsor's protocol ID
- SMC 2022-06-074
- Status last verified
- Jan 2023
- First submitted
- 21 Aug 2022
- Last updated
- 4 Jan 2023
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Body Composition Analysis in Predicting Delayed Emergence From Remimazolam-based General Anesthesia: A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05512559
- Acronym / sponsor ID
- SMC 2022-06-074
- Conditions
- Remimazolam, Body Composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 23 Aug 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.
Remimazolam is a novel general anesthetic drug. The time to emergence from remimazolam-based general anesthesia is variable among patients, but little is known about the risk factors for delayed emergence. We believe that information from body composition analysis may be helpful in understanding which patients are more likely to show delayed emergence from remimazolam.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| remimazolam | – | Device: body composition analysisgeneral anesthesia induction with 6mg/kg/hr continuous infusion of remimazolam. general anesthesia maintenance with 1mg/kg/hr continuous infusion of remimazolam. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam
Key inclusion criteria (1 listed)
- Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam
Key exclusion criteria (1 listed)
- Patients with preoperative mental change, hemodynamic instability, hemodialysis, heart failure, hypoalbuminemia, pregnancy
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 |
|---|---|---|
| body composition analysisBody composition analysis by bioelectrical impedance measurement, just before induction of anesthesia. | Device | remimazolam |
Primary outcome
emergence time
Time frame: at the time of emergence
relationship between body composition analysis information and time to emergence after discontinuing remimazolam infusion.
2 secondary outcomes
time to loss of consciousness
Time frame: at the time of induction
hypotension
Time frame: from induction to emergence of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: Undecided
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The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Remimazolam and Body Composition, run by Samsung 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 1 inclusion and 1 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 4 Jan 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.
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?
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?
emergence time (time frame: at the time of emergence). 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 4 Jan 2023.