UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057411 |
|---|---|
| Receipt number | R000065591 |
| Scientific Title | Comparison between Remimazolam and Propofol in patients undergoing Monitored Anesthesia Care for Peripheral Angioplasty: a randomized controlled trial |
| Date of disclosure of the study information | 2025/04/07 |
| Last modified on | 2025/03/26 15:56:48 |
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Basic information
Public title
Comparison between Remimazolam and Propofol in patients undergoing Monitored Anesthesia Care for Peripheral Angioplasty: a randomized controlled trial
Acronym
Remimazolam anesthesia for peripheral angioplasty
Scientific Title
Comparison between Remimazolam and Propofol in patients undergoing Monitored Anesthesia Care for Peripheral Angioplasty: a randomized controlled trial
Scientific Title:Acronym
Remimazolam anesthesia for peripheral angioplasty
Region
| Asia(except Japan) |
Condition
Condition
Monitored Anesthesia Care for Peripheral Angioplasty
Classification by specialty
| Vascular surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare hemodynamic stability and post-operative recovery between remimazolam and propofol anesthesia in patients who undergo monitored anesthesia care for peripheral angioplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total phenylephrine dose require to restore blood pressure during hypotensive events during the procedure
Key secondary outcomes
- The number of hypotension events
- Intraoperative vital signs: blood pressure, heart rate, pulse oximeter
- Recovery room stay time
- Patient satisfaction
- Surgeon satisfaction
- Adverse effects: arrhythmia, respiratory depression, anesthetic method conversion, unplanned ICU admission, intraoperative/postoperative nausea and vomiting)
- PPostoperative analgesic requirement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the intervention group, monitored anesthesia care is performed using intravenous remimazolam infusion.
Interventions/Control_2
In the intervention group, monitored anesthesia care is performed using intravenous propofol infusion.
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- ASA I-III
- Patients with peripheral vascular disease
- Peripheral angioplasty under monitored anesthesia care
Key exclusion criteria
- ASA IV, V
- Pregnancy
- Preexisting renal or hepatic dysfunction
- Patients with heart failure (EF <40%)
- Patients with coronary artery disease planning for interventional or surgical treatment
- Patient contraindicated for propofol or remimazolam administration (e.g. anaphylaxis)
- Alcohol or drug abuse
- Glaucoma
- Sleep apnea
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Jin-Woo |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7499
jinul8282@gmail.com
Public contact
Name of contact person
| 1st name | Jin-Woo |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7499
Homepage URL
jinul8282@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
HANA PHARM CO., LTD.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seoul National University Bundang Hospital
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
Tel
82-31-787-8801
snubhirb@gmail.com
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 | 04 | Month | 07 | 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
88
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 | 01 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 14 | 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 | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065591
