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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name