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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008443
Receipt No. R000009906
Scientific Title Effect of oral fluid infusion before cesarean section on intraoperative metabolism, hemodynamic changes and postoperative nausea and vomiting
Date of disclosure of the study information 2012/07/20
Last modified on 2015/01/12

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Basic information
Public title Effect of oral fluid infusion before cesarean section on intraoperative metabolism, hemodynamic changes and postoperative nausea and vomiting
Acronym Effect of oral fluid infusion before cesarean section on intraoperative metabolism, hemodynamic changes and postoperative nausea and vomiting
Scientific Title Effect of oral fluid infusion before cesarean section on intraoperative metabolism, hemodynamic changes and postoperative nausea and vomiting
Scientific Title:Acronym Effect of oral fluid infusion before cesarean section on intraoperative metabolism, hemodynamic changes and postoperative nausea and vomiting
Region
Japan

Condition
Condition cesarean section
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the intraoperative hemodynamic parameters, unbilical blood gas and glucose, postoperative nausea and vomiting between parturients receiving intravenous fluid infusions and oral fluid 3 hours before cesarean section.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nausea and vomiting within 24 hours after cesarean section
Key secondary outcomes 1. Electrolytes and blood glucose before anesthesia
2. Intraoperative blood pressure, heart rate, blood loss and duration of surgery
3. Unbilical blood gas and glucose

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 Oral intake of food is stopped after the evening of the day before cesarean section. Oral intake of fluid is also stopped after midnignt on the day of cesarean section. Fluid 10 ml/kg is administered orally 3 hours before anesthesia. Extracellular fluid 5 ml/kg is administered intravenously in 1 hour before anesthesia.
Interventions/Control_2 Oral intake of food is stopped after the evening of the day before cesarean section. Oral intake of fluid is also stopped after midnignt on the day of cesarean section. Extracellular fluid 5 ml/kg is administered intravenously in 1 hour before 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
35 years-old >
Gender Female
Key inclusion criteria Women undergoing elective ceserean section under spinal anesthesia
Key exclusion criteria Women
1. scheduled for cesarean section under general anesthesia
2. American Society of Anesthesiologists Physical Status higher than II
3. who are not able to take oral fluid before cesarean section
4. with body mass index > 35 kg/m2
5. with a history of abnormal reaction to local anesthetics
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryu Okutani
Organization Osaka City General Hospital and Children's Hospital
Division name Department of Anesthesiology
Zip code
Address 2-13-22 Miyakojima Hondori, Miyakojima-ku, Osaka 534-0021, Japan
TEL 81-6-6929-1221
Email ryuokutani0909@ybb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryu Okutani
Organization Osaka City General Hospital and Children's Hospital
Division name Department of Anesthesiology
Zip code
Address 2-13-22 Miyakojima Hondori, Miyakojima-ku, Osaka 534-0021, Japan
TEL 81-6-6929-1221
Homepage URL
Email ryuokutani0909@ybb.ne.jp

Sponsor
Institute Osaka City General Hospital and Children's Hospital
Institute
Department

Funding Source
Organization Osaka City General Hospital and Children's Hospital
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 07 Month 20 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
Oral rehydration before cesarean section increased the perturients' satisfaction and decreased the number of ifusion of vasopressors during anesthesia for cesarean section.
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 06 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 20 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 07 Month 16 Day
Last modified on
2015 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009906

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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