UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014348 |
|---|---|
| Receipt number | R000016702 |
| Scientific Title | Effect of immediate postoperative refeeding with oral carbohydrate-rich solution on nausea and vomiting after elective orthopedic surgery under general anesthesia |
| Date of disclosure of the study information | 2014/06/23 |
| Last modified on | 2022/12/28 12:44:45 |
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Basic information
Public title
Effect of immediate postoperative refeeding with oral carbohydrate-rich solution on nausea and vomiting after elective orthopedic surgery under general anesthesia
Acronym
Effect of postoperative carbohydrate drink on postoperative nausea and vomiting (PONV)
Scientific Title
Effect of immediate postoperative refeeding with oral carbohydrate-rich solution on nausea and vomiting after elective orthopedic surgery under general anesthesia
Scientific Title:Acronym
Effect of postoperative carbohydrate drink on postoperative nausea and vomiting (PONV)
Region
| Japan |
Condition
Condition
Osteoarthrities of the knee or the hip
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that immediate postoperative refeeding with carbohydrate-rich drink reduces the incidence of PONV compared to that with solid food in patients who undergo total knee or hip arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of PONV up to 5 hours after anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects are randomly allocated to two groups, the solid food group (control group) and carbohydrate drink group.Subjects in the carbohydrate drink group drink commercially avoidable 18% carbohydrate solution (Arginaid water, Nestle Japan) approximately 3 hours after general anesthesia.
Interventions/Control_2
Subjects in the control group eat the standard postoperative solid food in our hospital approximately 3 hours after general anesthesia.
Interventions/Control_3
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who undergo total knee or hip arthroplasty under combined general and epidural anesthesia
Key exclusion criteria
Diabetes mellitus
Heart disease
Smoking history in the past one year
Morbid obesity (BMI>35)
Corticosteroid medication
Gastroesophageal reflex disease
Administration of some narcotics antagonist analgesics except for remifentanyl during and up to 3 hours after anesthesia
PONV before oral intake of solid food / carbohydrate drink
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Chiho |
| Middle name | |
| Last name | Uneda |
Organization
Kumamoto Kinoh Hospital
Division name
Anesthesiology
Zip code
8608518
Address
Yamamuro 6-8-1 Kitaku Kumamoto, Japan 860-8516
TEL
096-345-8111
chihoanego@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Chiho |
| Middle name | |
| Last name | Uneda |
Organization
Kumamoto Kinoh Hospital
Division name
Anesthesiology
Zip code
8608518
Address
Yamamuro 6-8-1 Kitaku Kumamoto, Japan 860-8516
TEL
096-345-8111
Homepage URL
chihoanego@yahoo.co.jp
Sponsor or person
Institute
Kumamoto Kinoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Kinoh Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto Kinoh Hospital
Address
Yamamuro 6-8-1 Kitaku Kumamoto, Japan 860-8516
Tel
0963458111
chihoanego@yahoo.co.jp
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
熊本機能病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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 | 02 | Month | 12 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016702
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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