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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019825
Receipt No. 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

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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
Obsterics 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
Email 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
Email sasakawa@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Kushiro Red Cross Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022865

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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