UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044311 |
|---|---|
| Receipt number | R000050613 |
| Scientific Title | Effects on the cardiac conduction system revealed by analysis of heart rate variability in the use of Remimazolam (Single-blind, a prospective test) |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/01/24 07:01:18 |
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Basic information
Public title
The study of the effects of general anesthesia using Remimazolam on vital signs such as cardiovascular and blood pressure in surgical patients
Acronym
Effects of Remimazolam on Vital Signs in General Anesthetized Patients
Scientific Title
Effects on the cardiac conduction system revealed by analysis of heart rate variability in the use of Remimazolam (Single-blind, a prospective test)
Scientific Title:Acronym
Effects of Remimazolam on the cardiac conduction system (Single-blind, prospective study)
Region
| Japan |
Condition
Condition
All diseases that require surgery under general anesthesia
Classification by specialty
| Surgery in general | Obstetrics and Gynecology | Ophthalmology |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Urology | Anesthesiology | Neurosurgery |
| Cardiovascular surgery | Plastic surgery | Operative medicine |
| Emergency medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By comparing with the anesthetics used so far, it is shown that it is not inferior to the anesthetics used so far ,and in order to prove by heart rate variability analysis that the effect on hemodynamics, which is the merit and advantage of Remimazolam, is small.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1, ECG (RR interval, Tp-e, QTc time)
2, Blood pressure
3, Heart rate, pulse rate
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Induce anesthesia using Remimazolam.
Interventions/Control_2
Induce anesthesia using Propofol.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing general anesthesia, regardless of gender.
2) Patients scheduled to undergo mechanical ventilation management by tracheal intubation
3) Patients with ASA classification I or II
4) Patients who can fully explain the complications, indications, and disadvantages associated with inferior alveolar nerve conduction anesthesia using detailed explanatory documents, and obtain written consent (informed consent) at their own will.
Key exclusion criteria
1) Patients under the age of 20 at the time of obtaining the consent form
2) Patients with allergies, hypersensitivity or tolerance to the drugs used
3) Patients who meet the contraindications listed in the package insert of the drug to be used
4) Patients with AST (GOT) or ALT (GPT) of 100 IU / L or more in preoperative general clinical examination
5) Patients with Child-Pugh classification B or C
6) Patients with serum creatinine of 2.0 mg / dL or higher in general preoperative laboratory tests
7) Patients who have been using benzodiazepines for a long time
8) Patients with organic abnormalities in the brain who may not be able to properly measure EEG and BIS values
9) Patients scheduled to undergo epidural anesthesia / spinal anesthesia
10) Patients with cardiac pacemakers and ICDs
11) Lactating patients (except with the positive consent of the patient)
12) Other patients judged to be inappropriate by the principal investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kindai University Faculty of Medicine
Division name
Dapartment of Anesthesiology
Zip code
589-8511
Address
377-2, onohigashi, osaka-sayama, Osaka, Japan
TEL
072-366-0221
s-tsukimoto@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kindai University Faculty of Medicine
Division name
Dapartment of Anesthesiology
Zip code
589-8511
Address
377-2, onohigashi, osaka-sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
s-tsukimoto@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
no funding source
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
Kindai University Faculty of Medicine Ethics Committee
Address
377-2, onohigashi, osaka-sayama, Osaka, Japan
Tel
072-366-0221
zizen@med.kindai.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
| 2021 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050613
