UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of Bupivacaine-Fentanyl Spinal Anesthesia with Bupivacaine only Spinal Anesthesia for Surgical Repair of Hip Fracuture in the Aged regarding Hypotension preventive effect
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masatsugu Miyoko
Organization	St.Mary hospital
Division name	Department of Anesthesiology
Address	422 Tsubukuhon-machi Kurume city Fukuoka Japan
TEL	0942-35-3322
Email	tosutoshi@happytosu.ne.jp

Public contact
Name of contact person	Jun Yoshino
Organization	St.Mary Hospital
Division name	Department of Anesthesiology
Address	422 Tsubukuhon-machi Kurume city Fukuoka Japan
TEL	0942-35-3322
Homepage URL
Email	j-yoshino@st-mary-med.or.jp

Sponsor
Institute	St.Mary Hospital Department of Anesthesiology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025406