UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059210 |
|---|---|
| Receipt number | R000067631 |
| Scientific Title | Comparison of recovery profile after remimazolam-fentanyl anesthesia and propofol-fentanyl anesthesia for pulsed field ablation: a prospective randomized trial |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/26 18:13:43 |
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Basic information
Public title
Comparison of recovery profile after remimazolam-fentanyl anesthesia and propofol-fentanyl anesthesia for pulsed field ablation
Acronym
Investigation of recovery profile after remimazolam-fentanyl anesthesia for pulsed field ablation
Scientific Title
Comparison of recovery profile after remimazolam-fentanyl anesthesia and propofol-fentanyl anesthesia for pulsed field ablation: a prospective randomized trial
Scientific Title:Acronym
Comparison of recovery profile after remimazolam-fentanyl anesthesia and propofol-fentanyl anesthesia for pulsed field ablation
Region
| Japan |
Condition
Condition
patients with atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare recovery profile after remimazolam-fentanyl anesthesia and propofol-fentanyl anesthesia for pulsed field ablation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from the end of anesthetic administration to extubate the airway device
Key secondary outcomes
Time from the end of anesthetic administration to open eyes, to be able to respond to a call, and to reach a Fast-Track Criteria score of 12 or higher
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of propofol and fentanyl to maintain general anesthesia
Interventions/Control_2
The administration of propofol and fentanyl to maintain general anesthesia
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with atrial fibrillation scheduled for pulsed field ablation
Key exclusion criteria
Patients with hepatic dysfunction of Child-Pugh classification B or higher
Patients receiving renal replacement therapy
Severely obese patients (Body mass index 35 or higher)
Dementia patients
Patients who are allergic to anesthetics
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kondo |
Organization
Hiroshima Heart Center
Division name
Department of Anesthesiology
Zip code
7310113
Address
5-10, Nishihara, Asaminami-ku, Hiroshima
TEL
0828748080
yrdcn850@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kondo |
Organization
Hiroshima Heart Center
Division name
Department of Anesthesiology
Zip code
7310113
Address
5-10, Nishihara, Asaminami-ku, Hiroshima
TEL
0828748080
Homepage URL
yrdcn850@yahoo.co.jp
Sponsor or person
Institute
Hiroshima Heart Center
Institute
Department
Personal name
Takashi Kondo
Funding Source
Organization
Hiroshima Heart Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima Heart Center
Address
5-10, Nishihara, Asaminami-ku, Hiroshima
Tel
0828748080
ashoda@hhc.gr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067631
