UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036073
Receipt number R000041094
Scientific Title Effect of remifentanil on the intraoperative fluid balance
Date of disclosure of the study information 2019/03/04
Last modified on 2019/03/04 09:37:41

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Basic information

Public title

Effect of remifentanil on the intraoperative fluid balance

Acronym

Effect of remifentanil on the intraoperative fluid balance

Scientific Title

Effect of remifentanil on the intraoperative fluid balance

Scientific Title:Acronym

Effect of remifentanil on the intraoperative fluid balance

Region

Japan


Condition

Condition

General Anesthesia

Classification by specialty

Anesthesiology Oral surgery Dental medicine
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Retrospective explored the relationship between analgesics and in-out balance in surgical patients from anesthesia records

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

the amount of crystalloid and colloid, the amount of urine and bleeding

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

17 years-old <=

Age-upper limit

50 years-old >=

Gender

Male and Female

Key inclusion criteria

The consecutive patients who were undergoing orthognathic surgery to correct deformities of the maxilla and mandible from 2016 to 2017

Key exclusion criteria

None

Target sample size

84


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takehiko IIJIMA

Organization

School of Dentistry, Showa University

Division name

Department of Perioperative Medicine, Division of Anesthesiology

Zip code


Address

Kitasenzoku 2-1-1 Ohta City, Tokyo 145-8515

TEL

03-3787-1151

Email

iijima@dent.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akiko NISHIMURA

Organization

School of Dentistry, Showa University

Division name

Department of Perioperative Medicine, Division of Anesthesiology

Zip code


Address

Kitasenzoku 2-1-1 Ohta City, Tokyo 145-8515

TEL

03-3787-1151

Homepage URL


Email

nishim@dent.showa-u.ac.jp


Sponsor or person

Institute

Showa University

Institute

Department

Personal name



Funding Source

Organization

Showa University

Organization

Division

Category of Funding Organization

Other

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

昭和大学歯科病院


Other administrative information

Date of disclosure of the study information

2019 Year 03 Month 04 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

2019 Year 03 Month 04 Day

Date of IRB


Anticipated trial start date

2019 Year 03 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2019 Year 03 Month 04 Day

Last modified on

2019 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041094


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name