UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014951 |
|---|---|
| Receipt number | R000017393 |
| Scientific Title | The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2020/08/29 13:54:10 |
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Basic information
Public title
The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients
Acronym
The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients
Scientific Title
The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients
Scientific Title:Acronym
The study of postoperative intravenous patient-controlled (iv-PCA) analgesia used by oxycodone for Japanese Patients
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Definition the protocol of iv-PCA used by oxycodone for Japanese patients(contains patients with renal disorder)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement of pain
Key secondary outcomes
respiratory depression,
nausea, vomiting, itching,
change of drug concentration between before and after hemodialysis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Change postoperative analgesic agent to use for iv-PCA morphine hydrochloride to oxycodone hydrochloride
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
1.Patients are performed elective operation under general anesthesia for malignant tumor or suspicion.
2. General status of patients are stable and classified into ASA 1 or 2.
(object cases for elimination efficacy by hemodialysis contain belong to class 3)
3.Patients choice iv-PCA as methods for postoperative analgesia.
4.Patients stay intensive care unit after surgery and continue direct measurement of arterial pressure.
Key exclusion criteria
1.Difficult patient to obtain consent or judge efficacy by mental disease or symptom.
2.Contrradicated cases for oxycodene hydrochloride (severe respiratory supression, COPD, heart failure, asthma attack, ileus, diarrhea).
3.The value of Hb is under 8mg/dl when the patient entersj intensive care unit.
4.The patient is judged to require blood transfusion after operation.
5.Also, the doctor determine the patient is inadequate to attend the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koki |
| Middle name | |
| Last name | Taira |
Organization
Jichi Medical University
Division name
department of anesthesiology and critical care medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture, Japan
TEL
+81-285-58-7383
ktaira@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Koki |
| Middle name | |
| Last name | Taira |
Organization
Jichi Medical University
Division name
department of anesthesiology and critical care medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture, Japan
TEL
+81-285-58-7383
Homepage URL
ktaira@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Jichi Medical University Bioethics Committee
Address
3311-1, Yakushiji, Shimotsuke-city, Tochigi prefecture, Japan
Tel
+81-285-58-8933
rinri@jichi.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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
0
Results
We terminated trial with no registered cases.There are two reasons for discontinuation.
1)Decreasing of candidate cases by the change of operating methods and postoperative management (many cases go back to ward directly without monitoring by artery-line that can use as blood sampling line)
2)By enactment of Clinical Trials Act, the usage restriction of oxycodone in this study arise (the possibility for regarding usage as Off-label use)
Results date posted
| 2020 | Year | 08 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
For the above reasons, the number of patients who participated in this study decreased and it became difficult to carry out the study.
Participant flow
No participant was not registered.
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 23 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 23 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 25 | Day |
Last modified on
| 2020 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017393
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/08/29 | オキシコドン研究計画書提出用5訂版.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
