UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022118 |
|---|---|
| Receipt number | R000025406 |
| Scientific Title | Comparison of Bupivacaine-Fentanyl Spinal Anesthesia with Bupivacaine only Spinal Anesthesia for Surgical Repair of Hip Fracuture in the Aged regarding Hypotension preventive effect |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2016/04/28 13:45:39 |
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Basic information
Public title
Comparison of Bupivacaine-Fentanyl Spinal Anesthesia with Bupivacaine only Spinal Anesthesia for Surgical Repair of Hip Fracuture in the Aged regarding Hypotension preventive effect
Acronym
A Study of Subarachnoid Fentanyl beneficial effect for Surgial repeir of Hip Fracture in the Aged
Scientific Title
Comparison of Bupivacaine-Fentanyl Spinal Anesthesia with Bupivacaine only Spinal Anesthesia for Surgical Repair of Hip Fracuture in the Aged regarding Hypotension preventive effect
Scientific Title:Acronym
A Study of Subarachnoid Fentanyl beneficial effect for Surgial repeir of Hip Fracture in the Aged
Region
| Japan |
Condition
Condition
Hip Fracture
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of Bupivacaine plus Fentanyl spinal anesthesia and Bupivacaine only spinal anethesia for surgical repair of hip fracutre in the aged regarding hypotension preventive effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of hypotension occurrence during the operation
Key secondary outcomes
Required dosage of vasopressor during the operation
Anesthetic effect for the operation
Time till the first pain killer use after the operation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients for bupivacaine(10mg) only spinal anesthesia
Interventions/Control_2
Patients for bupivacaine(7.5mg) plus fentanyl(0.025mg) spinal anethesia
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients for surgical repair of hip fracture
Key exclusion criteria
Patients with asthma
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatsugu Miyoko |
Organization
St.Mary hospital
Division name
Department of Anesthesiology
Zip code
Address
422 Tsubukuhon-machi Kurume city Fukuoka Japan
TEL
0942-35-3322
tosutoshi@happytosu.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Yoshino |
Organization
St.Mary Hospital
Division name
Department of Anesthesiology
Zip code
Address
422 Tsubukuhon-machi Kurume city Fukuoka Japan
TEL
0942-35-3322
Homepage URL
j-yoshino@st-mary-med.or.jp
Sponsor or person
Institute
St.Mary Hospital
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
雪の聖母会聖マリア病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 10 | 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
Significantly less amount of vasoporessor wa used in fentanyl-bupivacaine group than
in bupivacaine only group.
Frequency of hypotension was less in fentanyl-bupivacaine group
This report was presemted at the 62nd Annual meeting of the Japanese society of Anesthesiologist
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
| 2013 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 28 | Day |
Last modified on
| 2016 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025406
