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Recruitment status Completed
Unique ID issued by UMIN UMIN000009388
Receipt No. R000011029
Scientific Title Randomized clinical trial comparing the quality of recovery among overnight fasting, preoperative oral rehydration solution, and preoperative oral carbohydrate
Date of disclosure of the study information 2012/11/22
Last modified on 2013/05/30

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Basic information
Public title Randomized clinical trial comparing the quality of recovery among overnight fasting, preoperative oral rehydration solution, and preoperative oral carbohydrate
Acronym Randomized clinical trial comparing the quality of recovery among overnight fasting, preoperative oral rehydration solution, and preoperative oral carbohydrate
Scientific Title Randomized clinical trial comparing the quality of recovery among overnight fasting, preoperative oral rehydration solution, and preoperative oral carbohydrate
Scientific Title:Acronym Randomized clinical trial comparing the quality of recovery among overnight fasting, preoperative oral rehydration solution, and preoperative oral carbohydrate
Region
Japan

Condition
Condition Patients scheduled for the surgery of body surface
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the quality of recovery, among overnight fasting, preoperative oral hydration solution, and preoperative oral carbohydrate, of the patients undergoing the body surface surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quality of recovery, 24 hours after anesthesia
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Preoperative oral carbonate group: drink 250ml of Arginaid Water at 6:00-6:30 on the morning of surgery
Interventions/Control_2 Preoperative oral rehydration solution group: drink 1000 ml of OS-1 from after dinner till 2 hours before anesthesia, additional 500ml is permitted if the surgery is due on afternoon
Interventions/Control_3 Preoperative fasting group: fasting from midnight
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
79 years-old >
Gender Male and Female
Key inclusion criteria ASA physical status 1 and 2 patients undergoing the surgery of body surface
Key exclusion criteria Patients with impaired gastrointestinal motility, gastroesophageal reflux, potential difficult airway, poor Japanese comprehension, or psychiatric disturbance
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayako Asakura
Organization Yokohama City University
Division name Department of Anesthesiology
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University
Division name Department of Anesthesiology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology, Yokohama City University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 11 Month 22 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 Completed
Date of protocol fixation
2012 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 06 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
2012 Year 11 Month 22 Day
Last modified on
2013 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011029


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