UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053512 |
|---|---|
| Receipt number | R000043360 |
| Scientific Title | Effects of epinephrine administration on mesentric traction syndrome |
| Date of disclosure of the study information | 2024/02/02 |
| Last modified on | 2024/02/01 16:16:14 |
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Basic information
Public title
Effects of epinephrine administration on mesentric traction syndrome
Acronym
epinephrine on MTS
Scientific Title
Effects of epinephrine administration on mesentric traction syndrome
Scientific Title:Acronym
Effects of epinephrine administration on mesentric traction syndrome
Region
| Japan |
Condition
Condition
patients who suspected mesentric traction syndrome during abdominal surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Obstetrics and Gynecology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of epinephrine administration on symptom of mesentric traction syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
percentage of patients who van recover from TS by administration of epinephrine
Key secondary outcomes
time for recovery from MTS
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who present tahycardia(>100), hypotension (<80), and face flush
Key exclusion criteria
allergy to epinephrine
patients with ischemic heart disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | hajime |
| Middle name | |
| Last name | kawase |
Organization
musashikosugi Hospital Nippon medical school
Division name
Department of anesthesiology
Zip code
211-8533
Address
1-396 kosugityou nakaharaku kawasaki-city
TEL
81-44-733-5181
hajime-kawase@nms.ac.jp
Public contact
Name of contact person
| 1st name | manzo |
| Middle name | suzuki |
| Last name | suzuki |
Organization
Musashikosugi Hospital Nippon Medical School
Division name
Anesthesiology
Zip code
211-8533
Address
1-396 kosugityou nakaharaku kawasai-city
TEL
817335181
Homepage URL
manzo@nms.ac.jp
Sponsor or person
Institute
department of anethesiology
Musashikosugi Hospital Nippon Medical school
Institute
Department
Personal name
Manzo Suzuki
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NA
Name of secondary funder(s)
NA
IRB Contact (For public release)
Organization
IRB committee Musashikosugi hospital nippon Medical school
Address
1-396 kosugityou nakaharaku kawasaki
Tel
81447335181
manzo@nms.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
日本医科大学武蔵小杉病院(神奈川県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.nms.ac.jp/var/rev0/0052/4130/1181025
Publication of results
Unpublished
Result
URL related to results and publications
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.nms.ac.jp/var/rev0/0052/4130/1181025
Number of participants that the trial has enrolled
8
Results
Results
In all eight patients, within 20 min after epinephrine treatment, the three MTS symptoms hypotension, tachycardia, and facial flushing had recovered.
Conclusion
Although this is a small trial, our data suggest that epinephrine is as effective as flurbiprofen in treating MTS but without some of its side effects, and is a very promising alternative drug for MTS treatment.
Results date posted
| 2024 | Year | 02 | Month | 01 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
I left the protocol just on administration. I forgot to describe the date of disclosure. Patients had been enrolled because IRB had approved.
had
Date of the first journal publication of results
Baseline Characteristics
Table1. Patient Characteristics
Patient number Sex Age Height (cm) Weight (Kg) Procedure
1 m 68 160 53 Low anterior resection of rectum
2 f 78 148 54 Total Abdominal hysterectomy
3 m 62 172 68 Total Gastrectomy
4 m 74 166 64 Total Gastrectomy
5 f 49 156 46 Uterine Myomectomy
6 m 61 173 66 Distal Gastrectomy
7 f 67 150 67 Distal Gastrectomy
8 f 81 165 70 Right Hemicolectomy
Participant flow
Participants were enrolled from October 2019 until October 2020. The patient's informed consent was obtained at the time of the preoperative anesthesia visit. Patients who developed MTS during gastrointestinal, colorectal, or gynecological surgery were investigated. One patient, who was younger than 18 years old and underwent laparoscopic surgery, was excluded from the study.
Adverse events
none
Outcome measures
recovery from symptoms of MTS, such as facial flushing, hypotension, and tachycardia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients had enrolled before the disclosure of the study. No patient harm was observed.
Management information
Registered date
| 2024 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043360
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| Registered date | File name |
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