UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008443 |
|---|---|
| Receipt number | 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 23:00:08 |
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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
| Obstetrics 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
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
ryuokutani0909@ybb.ne.jp
Sponsor or person
Institute
Osaka City General Hospital and Children's Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009906
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
