UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033021 |
|---|---|
| Receipt number | R000037644 |
| Scientific Title | Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy. |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2023/06/20 11:29:53 |
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Basic information
Public title
Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy.
Acronym
Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy.
Scientific Title
Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy.
Scientific Title:Acronym
Effects of thoracic epidural analgesia on diaphragmatic dysfunction after laparoscopic gastrectomy.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Anesthesiology | Intensive care medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of thoracic epidural analgesia with local anesthetics on diaphragmatic function after laparoscopic gastrectomy using respiratory inductive plethysmography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative pain, diaphragmatic function
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
epidural analgesia
Interventions/Control_2
iv PCA
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The patients underwent laparoscopic gastrectomy
2)ASA PS 1or 2
Key exclusion criteria
1)Patients' refusal to participate in clinical research
2)open abdominal surgery
3)general contraindications for epidural anaesthesia
4)patients with cardiorespiratory dysfunction
5)patients with liver of renal dysfunction
6)bleeding history, and regular medication interfering with blood coagulation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | NAOYUKI |
| Middle name | |
| Last name | FUJIMURA |
Organization
St. Mary's Hospital
Division name
Department of Anesthesiology
Zip code
8308543
Address
422 Tsubukuhonmachi Kurume, Fukuoka
TEL
0942-35-3322
n-fujimura@st-mary-med.or.jp
Public contact
Name of contact person
| 1st name | NAOYUKI |
| Middle name | |
| Last name | FUJIMURA |
Organization
St. Mary's Hospital
Division name
Department of Anesthesiology
Zip code
8308543
Address
422 Tsubukuhonmachi Kurume, Fukuoka
TEL
0942-35-3322
Homepage URL
n-fujimura@st-mary-med.or.jp
Sponsor or person
Institute
St. Mary's Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Mary's Hospital
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
St. Mary's Hospital Our Lady of the Snow Social Medical Corporation
Address
422 Tsubukuhonmachi, Kurume, Fukuoka
Tel
0942-35-332
n-fujimura@st-mary-med.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
14-0303
Org. issuing International ID_1
St. Mary's Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2025 | 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
| 2018 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037644
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
