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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000013554
Receipt No. 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

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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
Email 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
Email sasao-m@tsurumi-u.ac.jp

Sponsor
Institute School of Dental Medicine, Tsurumi University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015828

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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