RemimazolamPhase 4NCT05486377
Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia
A Phase 4 study testing Remimazolam besylate in people with Remimazolam and Desflurane, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In anesthesia for ablation for cardiac arrhythmias, abrupt hemodynamic changes or fatal arrhythmias can be seen frequently. Remimazolam is a novel ultra-short acting benzodiazepine that provides good hemodynamic stability compared to conventional anesthetic agents. Read more about this study
- Who is it for?
- Ages 20 to 105 years
- Conditions the study is for
- Remimazolam, Desflurane, Cryoablation
- What is being tested?
- Remimazolam besylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2022to 19 May 2023
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- =or > 20 years
- Admission for General anesthesia for RFCA or cryoablation procedure
Who cannot join
- No severe adverse effect history or hypersensitivity of benzodiazepines or its additives
- Acute alcoholic intoxication state
- Coma or shock state due to other condition than heart problem.
- Acute narrow-angle glaucoma
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national university Bundang hospital
Seongnam, Province (optional), 13620
About this study
Official title: Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial
In anesthesia for ablation for cardiac arrhythmias, abrupt hemodynamic changes or fatal arrhythmias can be seen frequently. Remimazolam is a novel ultra-short acting benzodiazepine that provides good hemodynamic stability compared to conventional anesthetic agents. This study aims to investigate whether remimazolam reduces vasoactive agent use during cryo/radiofrequancy ablation under general anesthesia, compared to desflurane(RCT).
- Conditions
- Remimazolam, Desflurane, Cryoablation, Arrhythmia, General Anesthesia
- Being tested
- Remimazolam besylate
- Keywords
- Remimazolam, Desflurane, Arrhythmia, Cryoablation,heart, Cardiovascular disease
- Medical subject headings
- Arrhythmias, Cardiac, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Remimazolam besylate TIVA
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | General anesthesia with remimazolam-remifentanil TIVA. Receives: Drug: Remimazolam besylate |
| Desflurane | No intervention | General anesthesia with maintaining with desflurane (induction:PPF, remifentanil CIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressor CIV
Vasopressor CIV or not
Measured: During anesthesia
Hypotension event
Hypotension event
Measured: During and after anesthesia
Vasopressor (total amount)
Norepinephrine equivalent dose
Measured: During anesthesia
Secondary outcomes (3)
Induction time
Induction dose administration~LOC
Measured: Induction
Recovery time
Reversal agent administration~extubation
Measured: Recovery
Adverse event
Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.)
Measured: During and after anesthesia (~24hr)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start2 Aug 2022
- Primary completion19 May 2023
- Study completion19 May 2023
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 Seoul National University Bundang 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Ae Song, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486377
- Sponsor's protocol ID
- B-2205-757-001
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2022
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yim S, Choi CI, Park I, Koo BW, Oh AY, Song IA. Remimazolam to prevent hemodynamic instability during catheter ablation under general anesthesia: a randomized controlled trial. Can J Anaesth. 2024 Aug;71(8):1067-1077. doi: 10.1007/s12630-024-02735-z. Epub 2024 Apr 12.
PubMed 38609684
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05486377
- Acronym / sponsor ID
- B-2205-757-001
- Conditions
- Remimazolam, Desflurane, Cryoablation, Arrhythmia, General Anesthesia
- Keywords
- Remimazolam, Desflurane, Arrhythmia, Cryoablation,heart, Cardiovascular disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 3 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.
In anesthesia for ablation for cardiac arrhythmias, abrupt hemodynamic changes or fatal arrhythmias can be seen frequently. Remimazolam is a novel ultra-short acting benzodiazepine that provides good hemodynamic stability compared to conventional anesthetic agents. This study aims to investigate whether remimazolam reduces vasoactive agent use during cryo/radiofrequancy ablation under general anesthesia, compared to desflurane(RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam besylateGeneral anesthesia with remimazolam-remifentanil TIVA. |
| Desflurane | No intervention | –General anesthesia with maintaining with desflurane (induction:PPF, remifentanil CIV) |
Who may qualify
- Ages
- 20 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- =or > 20 years
- Admission for General anesthesia for RFCA or cryoablation procedure
Key exclusion criteria (4 listed)
- No severe adverse effect history or hypersensitivity of benzodiazepines or its additives
- Acute alcoholic intoxication state
- Coma or shock state due to other condition than heart problem.
- Acute narrow-angle glaucoma
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 besylateRemimazolam besylate TIVA | Drug | Remimazolam |
Primary outcome
Vasopressor CIV
Time frame: During anesthesia
Vasopressor CIV or not
Hypotension event
Time frame: During and after anesthesia
Hypotension event
Vasopressor (total amount)
Time frame: During anesthesia
Norepinephrine equivalent dose
3 secondary outcomes
Induction time
Time frame: Induction
Recovery time
Time frame: Recovery
Adverse event
Time frame: During and after anesthesia (~24hr)
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 9 Aug 2023.
- Derived from this study: PubMed 38609684Yim S, Choi CI, Park I, Koo BW, Oh AY, Song IA. Remimazolam to prevent hemodynamic instability during catheter ablation under general anesthesia: a randomized controlled trial. Can J Anaesth. 2024 Aug;71(8):1067-1077. doi: 10.1007/s12630-024-02735-z. Epub 2024 Apr 12.
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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?
A Phase 4 study testing Remimazolam besylate in people with Remimazolam and Desflurane, run by Seoul National University Bundang Hospital 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 4 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 9 Aug 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?
Vasopressor CIV (time frame: During anesthesia). The study lists 3 primary outcomes in all. 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 NCT05486377, 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 9 Aug 2023.