UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of remifentanil on the intraoperative fluid balance
Title of the study (Brief title)	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	Takehiko IIJIMA
Organization	School of Dentistry, Showa University
Division name	Department of Perioperative Medicine, Division of Anesthesiology
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	Akiko NISHIMURA
Organization	School of Dentistry, Showa University
Division name	Department of Perioperative Medicine, Division of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 03 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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