HemodynamicNCT06700681
RCT Comparing Remimazolam With Propofol Under EEG DSA Guidance During Cardiac Electrophysiology Studies and Ablation
A study testing Propofol, Remimazolam and Maintain spontaneous ventilation without intubation in people with Hemodynamic and Remimazolam, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Brief Summary: The goal of this RCT is to compare the Safety and efficacy of remimazolam compared with propofol under EEG DSA guiding during cardiac electrophysiology studies and ablation. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hemodynamic, Remimazolam, Propofol
- What is being tested?
- Propofol, Remimazolam and Maintain spontaneous ventilation without intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient receives scheduled cardiac electrophysiology studies and ablation by the same cardiologist(one of the study investigator).
Who cannot join
- With existing vasopressor or shock status
- Patient refusal or cannot finish Mini-Cog or QoR-15 preoperatively
- Canceled by cardiologist
- Allergy history to the anesthetics used in this study
- History of abnormal lung function or required oxygen therapy preoperative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Remimazolam Compared With Propofol Under EEG DSA Guiding During Cardiac Electrophysiology Studies and Ablation: Randomized Controlled Trial
Brief Summary:
The goal of this RCT is to compare the Safety and efficacy of remimazolam compared with propofol under EEG DSA guiding during cardiac electrophysiology studies and ablation. The main questions it aims to answer are:
Read more
- Is Remimazolam as efficacy as propofol in cardiac electrophysiology studies and ablation?
- Is Remimazolam lower hypotension episodes or lower vasopressor dosages compare with propofol in cardiac electrophysiology studies and ablation? If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Researchers will compare Remimazolam to Propofol to see if Remimazolam is more feasible in cardiac electrophysiology studies and ablation.
Participants will receive either Remimazolam or Propofol sedation during study period.
- Conditions
- Hemodynamic, Remimazolam, Propofol, Cardiac Electrophysiology
- Being tested
- Propofol, Remimazolam, With intubation and controlled ventilation to maintain airway, Maintain spontaneous ventilation without intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
TIVA induction and maintain with Propofol.
RemimazolamDrug
TIVA induction and maintain with Remimazolam.
With intubation and controlled ventilation to maintain airwayDevice
Patient receives intubation and controlled ventilation to maintain airway.
Maintain spontaneous ventilation without intubationDevice
Patient maintains spontaneous ventilation without intubation.
| Study group | Role | What they receive |
|---|---|---|
| TIVA with Propofol and intubation | Placebo comparator | Patient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with intubation and controlled ventilation. Receives: Drug: Propofol; Device: With intubation and controlled ventilation to maintain airway |
| TIVA with Remimazolam and intubation | Experimental | Patient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with intubation and controlled ventilation. Receives: Drug: Remimazolam; Device: With intubation and controlled ventilation to maintain airway |
| TIVA with Propofol and non-Intubated | Experimental | Patient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with spontaneous ventilation without intubation(non-intubated). Receives: Drug: Propofol; Device: Maintain spontaneous ventilation without intubation |
| TIVA with Remimazolam and non-Intubated | Experimental | Patient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with spontaneous ventilation without intubation(non-intubated). Receives: Drug: Remimazolam; Device: Maintain spontaneous ventilation without intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic stability--Vasopressor dosage
Total dosage of vasopressor used during the procedure
Measured: Introperative
Secondary outcomes (10)
Respiratory depression require intubation
The incidence of patients in non-intubated groups receive intubation
Measured: Introperative
TIVA failure rate
The incidence of TIVA shift to inhalation anesthetics
Measured: Introperative
LOC time
Time from start induction to loss of conscious
Measured: Introperative
Emergence time
Time from stop intravenous anesthetics infusion to eye opening
Measured: Introperative
Sanctification of cardiologist
The sanctification score of the cardiologist
Measured: Perioperative
QoR-15
The result of QoR-15 score
Measured: Preoperative to post-operative day 1
Mini-Cog
The result of Mini-Cog score
Measured: Preoperative to post-operative day 1
Length of hospital stay
Length of hospital stay
Measured: Upto 1 month
Adverse outcome
Any adverse outcome
Measured: Upto 1 month
Length of CU stay
Length of CU stay
Measured: Upto 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start20 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Li Yi-Shiuan, Bachelor's, Study director, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700681
- Sponsor's protocol ID
- 2024-06-005B
- Status last verified
- Nov 2024
- First submitted
- 10 Sep 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Remimazolam Compared With Propofol Under EEG DSA Guiding During Cardiac Electrophysiology Studies and Ablation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06700681
- Acronym / sponsor ID
- 2024-06-005B
- Conditions
- Hemodynamic, Remimazolam, Propofol, Cardiac Electrophysiology
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Nov 2024 (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.
Brief Summary:
The goal of this RCT is to compare the Safety and efficacy of remimazolam compared with propofol under EEG DSA guiding during cardiac electrophysiology studies and ablation. The main questions it aims to answer are:
- Is Remimazolam as efficacy as propofol in cardiac electrophysiology studies and ablation?
- Is Remimazolam lower hypotension episodes or lower vasopressor dosages compare with propofol in cardiac electrophysiology studies and ablation? If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Researchers will compare Remimazolam to Propofol to see if Remimazolam is more feasible in cardiac electrophysiology studies and ablation.
Participants will receive either Remimazolam or Propofol sedation during study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TIVA with Propofol and intubation | Placebo comparator | Drug: Propofol, Device: With intubation and controlled ventilation to maintain airwayPatient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with intubation and controlled ventilation. |
| TIVA with Remimazolam and intubation | Experimental | Drug: Remimazolam, Device: With intubation and controlled ventilation to maintain airwayPatient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with intubation and controlled ventilation. |
| TIVA with Propofol and non-Intubated | Experimental | Drug: Propofol, Device: Maintain spontaneous ventilation without intubationPatient received cardiac electrophysiology studies and ablation under TIVA with Propofol induction and maintenance and airway is maintained with spontaneous ventilation without intubation(non-intubated). |
| TIVA with Remimazolam and non-Intubated | Experimental | Drug: Remimazolam, Device: Maintain spontaneous ventilation without intubationPatient received cardiac electrophysiology studies and ablation under TIVA with Remimazolam induction and maintenance and airway is maintained with spontaneous ventilation without intubation(non-intubated). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient receives scheduled cardiac electrophysiology studies and ablation by the same cardiologist(one of the study investigator).
Key exclusion criteria (5 listed)
- With existing vasopressor or shock status
- Patient refusal or cannot finish Mini-Cog or QoR-15 preoperatively
- Canceled by cardiologist
- Allergy history to the anesthetics used in this study
- History of abnormal lung function or required oxygen therapy preoperative
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 |
|---|---|---|
| PropofolTIVA induction and maintain with Propofol. | Drug | TIVA with Propofol and intubation, TIVA with Propofol and non-Intubated |
| RemimazolamTIVA induction and maintain with Remimazolam. | Drug | TIVA with Remimazolam and intubation, TIVA with Remimazolam and non-Intubated |
| With intubation and controlled ventilation to maintain airwayPatient receives intubation and controlled ventilation to maintain airway. | Device | TIVA with Propofol and intubation, TIVA with Remimazolam and intubation |
| Maintain spontaneous ventilation without intubationPatient maintains spontaneous ventilation without intubation. | Device | TIVA with Propofol and non-Intubated, TIVA with Remimazolam and non-Intubated |
Primary outcome
Hemodynamic stability--Vasopressor dosage
Time frame: Introperative
Total dosage of vasopressor used during the procedure
10 secondary outcomes
Respiratory depression require intubation
Time frame: Introperative
TIVA failure rate
Time frame: Introperative
LOC time
Time frame: Introperative
Emergence time
Time frame: Introperative
Sanctification of cardiologist
Time frame: Perioperative
QoR-15
Time frame: Preoperative to post-operative day 1
Mini-Cog
Time frame: Preoperative to post-operative day 1
Length of hospital stay
Time frame: Upto 1 month
Adverse outcome
Time frame: Upto 1 month
Length of CU stay
Time frame: Upto 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Hemodynamic
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Li Yi-Shiuan, Bachelor's study director
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol, Remimazolam and Maintain spontaneous ventilation without intubation in people with Hemodynamic and Remimazolam, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 5 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: enrolling by invitation, as of the sponsor's last update on 22 Nov 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hemodynamic stability--Vasopressor dosage (time frame: Introperative). 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 22 Nov 2024.