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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036073
Receipt No. 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

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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
Institute Showa University
Institute
Department

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
URL(English) https://upload.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


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