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
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
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
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
