UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009388 |
|---|---|
| Receipt number | 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 14:05:01 |
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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
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
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
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
Sponsor or person
Institute
Department of Anesthesiology, Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011029
