UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047384
Receipt number 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 2023/08/10 13:42:05

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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

- Total phenylephrine dose required to restore blood pressure during hypotensive events during the procedure

Key secondary outcomes

- The number of hypotension events
- Intraoperative remifentanil dose
- Time from the end of hemostatic compression to return of spontaneous breathing, time to eye opening, time to extubation, and time to orientation recovery
- Time from the end of hemostatic compression to BIS 75, time from flumazenil injection to extubation, time from flumazenil injection to return of orientation (only in remimazolam group)
- Intraoperative vital signs


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
- Multiple aneurysms
- History of neuromuscular/cognitive/psychiatric disease (on medication)
- 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 or person

Institute

Seoul National University Bundang Hospital

Institute

Department

Personal name



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

76

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

No longer recruiting

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 09 Month 29 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

2023 Year 08 Month 10 Day



Link to view the page

Value
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