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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047384
Receipt No. R000054046
Scientific Title Comparison of remimazolam and propofol anesthesia for interventional neuroradiology
Date of disclosure of the study information 2022/04/04
Last modified on 2022/06/15

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Basic information
Public title Comparison of remimazolam and propofol anesthesia for interventional neuroradiology
Acronym Remimazolam anesthesia for interventional neuroradiology
Scientific Title Comparison of remimazolam and propofol anesthesia for interventional neuroradiology
Scientific Title:Acronym Remimazolam anesthesia for interventional neuroradiology
Region
Asia(except Japan)

Condition
Condition IV general anesthesia for interventional neuroradiology
Classification by specialty
Vascular surgery Anesthesiology Neurosurgery
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 interventional neuroradiology
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of the events that mean blood pressure falls below 80% of basal pressure
Key secondary outcomes - Number of the events that patient moves during general anesthesia
- The time it takes for Bis to reach 75 after the surgery
- The time it takes for spontaneous breathing to begin after the surgery
- The time it takes for recovery of orientation after the surgery

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, general anesthesia is performed using intravenous remimazolam infusion.
Interventions/Control_2 In the intervention group, general anesthesia 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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria - ASA I-III
- Unruptured intracranial aneurysm
- Coiling procedures
Key exclusion criteria - A ruptured aneurysm
- History of neurologic/cognitive/psychiatric disease (on medication)
- Alcohol or drug abuse
- Preexisting renal or hepatic dysfunction
- Glaucoma
Target sample size 76

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
Email 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
Email jinul8282@gmail.com

Sponsor
Institute Seoul National University Bundang Hospital
Institute
Department

Funding Source
Organization Seoul National University Bundang Hospital
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
Email 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
2022 Year 04 Month 04 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 Enrolling by invitation
Date of protocol fixation
2022 Year 04 Month 04 Day
Date of IRB
2022 Year 01 Month 06 Day
Anticipated trial start date
2022 Year 05 Month 12 Day
Last follow-up date
2022 Year 05 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
2022 Year 04 Month 04 Day
Last modified on
2022 Year 06 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054046

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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