UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013554 |
|---|---|
| Receipt number | R000015828 |
| Scientific Title | Preoperative fluid management using oral rehydration therapy for perioperative stress from oral maxillofacial surgery |
| Date of disclosure of the study information | 2014/03/28 |
| Last modified on | 2016/03/28 18:09:24 |
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Basic information
Public title
Preoperative fluid management using oral rehydration therapy for perioperative stress from oral maxillofacial surgery
Acronym
Preoperative fluid management using oral rehydration therapy for perioperative stress from oral maxillofacial surgery
Scientific Title
Preoperative fluid management using oral rehydration therapy for perioperative stress from oral maxillofacial surgery
Scientific Title:Acronym
Preoperative fluid management using oral rehydration therapy for perioperative stress from oral maxillofacial surgery
Region
| Japan |
Condition
Condition
progenie
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developement of preoperative fluid management using oral rehydration therapy for enhanced recovery after oral maxillofacial surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body water blance, stress response, insulin resistance, patient satisfaction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
control: water 1500mL
oral intake after evening meal until 2 hours before surgery
Interventions/Control_2
oral rehydration solution: OS-1 1500mL
oral intake after evening meal until 2 hours before surgery
Interventions/Control_3
high concentration carbohydrate water:
pocarisweat ion water 500mL
preOp 200mL, water 810mL
oral intake after evening meal until 2 hours before surgery
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
| 44 | years-old | > |
Gender
Male and Female
Key inclusion criteria
morning elective surgery: sagital split ramus osteotomy
ASA-PS 1
Key exclusion criteria
ASA-PS 2-5
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mami Sasao-Takano |
Organization
School of Dental Mediscine, Tsurumi University
Division name
Department of Dental Anesthesiology
Zip code
Address
2-1-3 Tsurumi Tsurumi-ku Yokohama, 230-8501 Japan
TEL
045-580-8341
sasao-m@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mami Sasao-Takano |
Organization
School of Dental Medicine, Tsurumi University
Division name
Department of Dental Anesthesiology
Zip code
Address
2-1-3 Tsurumi Tsurumi-ku, Yokohama, 230-8501 Japan
TEL
045-850-8341
Homepage URL
sasao-m@tsurumi-u.ac.jp
Sponsor or person
Institute
School of Dental Medicine, Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Reseach (C)
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Suspended
Date of protocol fixation
| 2013 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 28 | Day |
Last modified on
| 2016 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015828
