UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018927 |
|---|---|
| Receipt number | R000021803 |
| Scientific Title | Pilot Research regarding an appropriate bolus dosage of intermittent epidural analgesia |
| Date of disclosure of the study information | 2015/09/15 |
| Last modified on | 2016/09/04 07:26:47 |
* 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
Pilot Research regarding an appropriate bolus dosage of intermittent epidural analgesia
Acronym
ADIEA
Scientific Title
Pilot Research regarding an appropriate bolus dosage of intermittent epidural analgesia
Scientific Title:Acronym
ADIEA
Region
| Japan |
Condition
Condition
Patients of liver disease with open liver resection requiring epidural analgesia
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The main reason is to clarify the appropriate dosage of intermittent epidural analgesia for the patients with open liver resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will investigate the good pain control without side effects.
Key secondary outcomes
The information regarding pump usage of analgesia and frequency of bolus and request. The information of other analgegics
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Appropriate dosage of intermittent epidural analgesia
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 with acquired consent
2) Conscious patients enable to do the conversation
Key exclusion criteria
1) allergy for analgesics
2) Renal dysfunction (Serum Creatinin 2.0 mg/dL)
3) Liver dysfunction (Serum AST/ALT >100 mg/dL)
4) Severe Heart dysfunction (Ejection fraction <40%)
5) Patients with convulsion
6) Severe asthma
7) Difficult procedure of epidural analgesia
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Matsusaki |
Organization
Okayama University Hospital
Division name
Intensive Care Unit
Zip code
Address
2
TEL
086-235-7778
matusakik@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Matsusaki |
Organization
OKAYAMA UNIVERSITY HOSPITAL
Division name
Intensive Care Unit
Zip code
Address
2-5-1 Kitaku Shikatacho
TEL
086-235-7778
Homepage URL
matusakik@ybb.ne.jp
Sponsor or person
Institute
Department of Anesthesiology and Resuscitology
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology and Resuscitology
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
Address
Tel
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
| 2015 | Year | 09 | Month | 15 | 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
| 2015 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 07 | Day |
Last modified on
| 2016 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021803
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/09/04 | 研究計画書 硬膜外間欠投与 最終0817.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/09/04 | 患者データシート （症例毎）.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/09/04 | 硬膜外間欠投与まとめ.pptx |
