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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name