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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014348
Receipt No. 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 2020/06/29

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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
Email 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
Email chihoanego@yahoo.co.jp

Sponsor
Institute Kumamoto Kinoh Hospital
Institute
Department

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
Email 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 Open public recruiting
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
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016702

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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