UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059892 |
|---|---|
| Receipt number | R000068493 |
| Scientific Title | Can remimazolam administration prevent hypotension during induction? |
| Date of disclosure of the study information | 2025/11/26 |
| Last modified on | 2025/11/26 18:06:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Can remimazolam administration prevent hypotension during induction?
Acronym
Can remimazolam administration prevent hypotension during induction?
Scientific Title
Can remimazolam administration prevent hypotension during induction?
Scientific Title:Acronym
Can remimazolam administration prevent hypotension during induction?
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia in the operation room
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observe through hemodynamic monitoring the extent to which remimazolam can prevent hypotension during induction of anesthesia, comparing it with propofol administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of Hypotension Incidence Between Groups from Anesthesia Induction to Pre-Surgical Intervention
Hypotension is defined as a decrease in systolic blood pressure of 20% or more from baseline values, or a mean arterial pressure below 65 mmHg.
Key secondary outcomes
1.Comparison of the amount and frequency of vasopressor use, fluid volume administered, frequency and severity of hypotension, and duration (area under threshold curve and time-weighted average) during induction in both groups
2.Comparison of BP, HR, CVV, SVI, and CI in each group relative to baseline values (pre-induction)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is 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
Remimazolam is used as the induction agent during anesthesia, and hemodynamic parameters are monitored.
Interventions/Control_2
Propofol is used as the drug for induction of anesthesia, and hemodynamic parameters are monitored.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 18 years or older who, after receiving adequate explanation regarding participation in this study, provided written consent based on full understanding and of their own free will
2.Patients with mild to moderate heart disease
3.Patients at risk of massive bleeding
The above patient groups meet the criteria for HPI (Hypotension Prediction Index) insurance coverage. In these patients, induction of anesthesia may cause circulatory fluctuations, potentially leading to hypotension or bradycardia. This study aims to evaluate whether remimazolam use contributes to circulatory stabilization in this patient population.
Key exclusion criteria
1.Severe heart disease (NYHA Class 3-4 heart failure, EF <30%, Rest angina or acute myocardial infarction within 3 months, uncontrollable severe arrhythmia, severe valvular disease such as aortic stenosis (AVA < 1.0 cm2, mean pressure gradient > 40 mmHg) or severe mitral regurgitation causing markedly impaired cardiac function, severe pulmonary hypertension (e.g., mean pulmonary artery pressure > 45 mmHg, cases with high risk of right heart failure)
2.Patients with allergies to the induction agent
3.Patients undergoing hemodialysis therapy
4.Patients with severe hepatic impairment (Child-Pugh class C or higher)
5.Patients with atrial fibrillation or atrial/ventricular premature contractions
6.Obese patients with BMI > 35
7.Patients in shock, e.g., mean blood pressure < 70 mmHg prior to anesthesia induction
8.Patients with failed initial oral endotracheal intubation
9.Cases where patient consent cannot be obtained despite family/proxy consent
10.Other patients deemed unsuitable for inclusion by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Ichikawa |
Organization
Adachi Medical Center, Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
123-8558
Address
4-33-1 Kohoku, Adachi, Tokyo
TEL
03-3857-0111
ichikawa.junko@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Fukuda |
Organization
Adachi Medical Center, Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
123-8558
Address
4-33-1 Kohoku, Adachi, Tokyo
TEL
03-3857-0111
Homepage URL
fukuda.tomoki@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University Clinical and Academic Research Promotion center
Address
8-1 Kawadacho, Shinjuku Ward, Tokyo
Tel
03-3353-8111
rinri.bm@twmu.ac.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 | 11 | Month | 26 | 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 | 11 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2030 | 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 | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068493
