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

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 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


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

Value
https://center6.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