UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021731 |
|---|---|
| Receipt number | R000023457 |
| Scientific Title | Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/09/16 14:49:14 |
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Basic information
Public title
Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery
Acronym
Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery
Scientific Title
Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery
Scientific Title:Acronym
Difference of the post operative analgesia effect between single and continuous Fentanyl injection during surgery
Region
| Japan |
Condition
Condition
Total Hip Arthroplasty
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
method of administration of intraoperative fentanyl is continuously administered with a single dose, but ther is the possibility that the difference of the analgesic effect, side effects . Therefore, we will compare the differences between the effects and side effects of taking the two methods of administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Analgesic effect, time until awakening, the frequency of use of vasopressors, impact on the respiratory rate and blood pressure and pulse rate, the presence or absence of nausea and vomiting
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
continuous infusion of fentanyl 4mcg/kg during total hip surgery(about 1 hour).
Interventions/Control_2
single shot of fentanyl 4mcg/kg 15 minutes before the end of total hip surgery.
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
Female
Key inclusion criteria
ASA1-2
Key exclusion criteria
fentanyl allergy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichi Yasuda |
Organization
NissanTamagawa Hospital
Division name
Department of Anesthesia
Zip code
Address
4-8-1 Seta,Setagaya-ku,Tokyo 158-0095 Japan
TEL
03-3700-1151
ysd5963@wave.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichi Yasuda |
Organization
NissanTamagawa Hospital
Division name
Department of Anesthesia
Zip code
Address
4-8-1 Seta,Setagaya-ku,Tokyo 158-0095 Japan
TEL
03-3700-1151
Homepage URL
ysd5963@wave.plala.or.jp
Sponsor or person
Institute
NissanTamagawa Hospital Department of Anesthesia
Institute
Department
Personal name
Funding Source
Organization
Nissan Kohseikai Institute of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2016 | Year | 04 | Month | 01 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 16 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 01 | Day |
Last modified on
| 2016 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023457
