UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049592 |
|---|---|
| Receipt number | R000056451 |
| Scientific Title | Impact of ondansetron and droperidol about change of corrected QT interval under general anesthesia: a retrospective observational study |
| Date of disclosure of the study information | 2022/11/24 |
| Last modified on | 2023/05/29 10:25:29 |
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Basic information
Public title
Impact of ondansetron and droperidol about change of corrected QT interval under general anesthesia: a retrospective observational study
Acronym
Impact of ondansetron and droperidol about change of corrected QT interval under general anesthesia: a retrospective observational study
Scientific Title
Impact of ondansetron and droperidol about change of corrected QT interval under general anesthesia: a retrospective observational study
Scientific Title:Acronym
Impact of ondansetron and droperidol about change of corrected QT interval under general anesthesia: a retrospective observational study
Region
| Japan |
Condition
Condition
patients who undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess the change of corrected QT interval about before and after administration of ondansetron or droperidol during general anesthesia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
corrected QT interval about every 1 minute from 0 to 10 min and at 30 min after the administration of target drug
Key secondary outcomes
1. difference of corrected QT interval between the group of maintenance drug of general anesthesia
2. difference of corrected QT interval between the group of target drug
3. incidence of prolongation of corrected QT interval more than 10 ms
4. number of occurrence of postoperative nausea and vomiting
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient who underwent general anesthesia and was administrated ondansetron or droperidol intravenously in our institution during from October 1st, 2019 to September 30th, 2022
Key exclusion criteria
1. patient who was administrated other drugs which affect QT interval (drugs which have description about prolongation of QT interval in Japan Pharmaceutical Reference) during from the start of general anesthesia to 30 min after the administration of target drug
2. patient who was administrated both ondansetron and droperidol during from the start of general anesthesia to 30 min after the administration of target drug
3. patient who was administrated target drug more than once
4. patient who was terminated the general anesthesia and the recording of patient monitor before the 30min after the administration of target drug
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Mitsuzawa |
Organization
Shinshu University School of Medicine
Division name
The Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2670
mitsukuni@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Mitsuzawa |
Organization
Shinshu University School of Medicine
Division name
The Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2670
Homepage URL
mitsukuni@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
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
Shinshu University School of Medicine Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2022 | Year | 11 | Month | 24 | 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
360
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
| 2022 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
to perform the retrospective analysis about the corrected QT interval before and after the administration of ondansetron and droperidol by acquiring the patient monitor data during general anesthesia and assess the difference of corrected QT interval between the group of patient with inhalational anesthetic and patient with intravenous anesthetic.
Management information
Registered date
| 2022 | Year | 11 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056451
