UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019825 |
|---|---|
| Receipt number | R000022865 |
| Scientific Title | Effect of preoperative oral rehydration solutions before cesarean section on ultrasound assessment of gastric volume and intraoperative hemodynamic changes |
| Date of disclosure of the study information | 2015/11/17 |
| Last modified on | 2018/05/20 20:18:35 |
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Basic information
Public title
Effect of preoperative oral rehydration solutions before cesarean section on ultrasound assessment of gastric volume and intraoperative hemodynamic changes
Acronym
Effect of preoperative oral rehydration solutions before cesarean section on ultrasound assessment of gastric volume and intraoperative hemodynamic changes
Scientific Title
Effect of preoperative oral rehydration solutions before cesarean section on ultrasound assessment of gastric volume and intraoperative hemodynamic changes
Scientific Title:Acronym
Effect of preoperative oral rehydration solutions before cesarean section on ultrasound assessment of gastric volume and intraoperative hemodynamic changes
Region
| Japan |
Condition
Condition
patients undergoing cesarean section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the gastric content, total intraoperative consumption of vasopressor agent, umbilical blood gas between patients control group and receiving oral fluid going to sleep and 2hours before cesarean section.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Total consumption of vasopressor agent
Key secondary outcomes
1.Stomach contents measuring by abdominal ultrasound
2. Electrolytes and blood glucose before anesthesia
3.Intraoperative blood pressure, heart rate, blood loss and duration of surgery
4.Umbical code blood gas analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver |
Interventions/Control_1
Oral intake of food and fluid are stopped after the evening of the day before cesarean section. Administering 6% hydroxyethyl starch (HES) that contains a normal saline solution as an initial infusion after inserting the peripheral venous catheter at the operation room. A total infusion volume of HES is 1000ml.
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 2hours prior to the cesarean section. Patients in OS-1 group intake OS-1 500ml before going to sleep and before 2hours prior to the scheduled operation time.
Administering 6% hydroxyethyl starch (HES) that contains a normal saline solution as an initial infusion after inserting the peripheral venous catheter at the operation room. A total infusion volume of HES is 1000ml.
Interventions/Control_3
Oral intake of food is stopped after the evening of the day before cesarean section. Oral intake of fluid is also stopped 2hours prior to the cesarean section. Patients in mineral water group intake mineral water 500ml before going to sleep and before 2hours prior to the scheduled operation time.
Administering 6% hydroxyethyl starch (HES) that contains a normal saline solution as an initial infusion after inserting the peripheral venous catheter at the operation room. A total infusion volume of HES is 1000ml.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients undergoing elective cesarean section under CSEA
Informed consent was obtained from all patients.
Key exclusion criteria
1.Emergency Sesarean section
2.Scheduled for cesarean section under general anesthesia
3.With multiple fetus
4.Abnprmal pregnancy(Placenta previa,Placenta accrete and so on)
5.Complications of pregnancy(PIH,GDM,bleeding disorders and coagulopathy and so on)
6.Fetal anomalies
7.Patient who could not be undergo epidural anesthesia
8.The case that anesthesiologist judge inappropriate
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoki Sasakawa |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
2-1-1-1 Midorigaokahigashi , Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
sasakawa@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoki Sasakawa |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
2-1-1-1 Midorigaokahigashi , Asahikawa, Hokkaido, Japan
TEL
0166-68-2583
Homepage URL
sasakawa@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Kushiro Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Kushiro Red Cross 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
釧路赤十字病院(北海道)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 17 | 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
| 2014 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 17 | Day |
Last modified on
| 2018 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022865
