UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056673 |
|---|---|
| Receipt number | R000064775 |
| Scientific Title | Effect of remimazolam on cardiac repolarization during modified electroconvulsive therapy |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/09 15:16:39 |
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Basic information
Public title
Effect of remimazolam on cardiac repolarization during modified electroconvulsive therapy
Acronym
Remimazolam on cardiac repolarization
Scientific Title
Effect of remimazolam on cardiac repolarization during modified electroconvulsive therapy
Scientific Title:Acronym
Remimazolam on cardiac repolarization
Region
| Japan |
Condition
Condition
Schizophrenia and depression
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is that Tpeak-Tend and QT dispersion as an index of cardiac repolarization after administration of propofol or remimazilam will be assessed during modified electroconvulsive therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tpeak-Tend
Key secondary outcomes
QT-dispersion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients scheduled to undergo mECT will be assigned to group R or group P. In group R: iv remimazolam (12mg/kg/h), after administration of 1 mg/kg succinylcholine, eECT will be performed. The Tpeak-Tend and QT dispersion will be measured and compared between two groups at the points of 1) before administration, 2) after sedation, 3) every 1 min after electrical stimulation.
Interventions/Control_2
Group P: iv propofol (1mg/kg), after administration of 1 mg/kg succinylcholine, eECT will be performed. The Tpeak-Tend and QT dispersion will be measured.
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 physical status 1 or 2, aged 20-65 years who are scheduled to undergo modified electroconvulsive therapy will be included. We will receive written informed consent from all patients
Key exclusion criteria
1) We excluded patients with cardiovascular diseases and those with preoperative ECG abnormalities.
2) Patients contraindicated with remimazolam or propofol will be excluded.
3) Patients who are ineligible for this study by medical doctor will be excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi, japan
TEL
0282861111
takasusu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Shouta |
| Middle name | |
| Last name | Katayanagi |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi, japan
TEL
0282861111
Homepage URL
takasusu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Shigeki Yamaguchi
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Tochigi, japan
Tel
0282861111
takasusu@dokkyomed.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 | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | 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 | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064775
