UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051958 |
|---|---|
| Receipt number | R000059301 |
| Scientific Title | Effect of remifentanil on Tpeak-Tend interval during electroconvulsive therapy |
| Date of disclosure of the study information | 2024/08/21 |
| Last modified on | 2025/08/25 11:16:14 |
* 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
Effect of remifentanil on Tpeak-Tend interval during electroconvulsive therapy
Acronym
Effect of remifentanil on TpTe
Scientific Title
Effect of remifentanil on Tpeak-Tend interval during electroconvulsive therapy
Scientific Title:Acronym
Effect of remifentanil on TpTe
Region
| Japan |
Condition
Condition
Schizophrenia and depression
Classification by specialty
| Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of remifentanil on cardiac repolarization during electroconvulsive therapy (ECT), we will measure Tpeak-Tend (TpTe) on electrocardiogram (ECG).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TpTe, TpTe/QT, TpTe/QTc, TpTe/RR
Key secondary outcomes
Systolic Blood pressure, diastolic blood pressure, RR interval.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Pretreatment of remifentanil
Interventions/Control_2
No treatment
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
American Society of Anesthesiologists (ASA) physical status 1 or 2, aged 20 to 65 years, who were scheduled to undergo modified electroconvulsive therapy (mECT) with written informed consent.
Key exclusion criteria
We exclude patients with cardiovascular, respiratory, metabolic, or cerebrovascular diseases, and those with preoperative electrocardiogram (ECG) abnormalities, allergy with remifentanil, pregnancy.
Target sample size
40
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 3210293 Japan
TEL
0282-86-1111
takasusu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Takasusuki |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
3210293
Address
880 kitakobayashi, Mibu, Tochigi 3210293 Japan
TEL
0282-86-1111
Homepage URL
takasusu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
Dokkyo Medical University
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
| 2024 | Year | 08 | Month | 21 | 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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 21 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059301
