UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of preoperative oral rehydration solutions before cesarean section on ultrasound assessment of gastric volume and intraoperative hemodynamic changes
Title of the study (Brief title)	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	Tomoki Sasakawa
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
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	Tomoki Sasakawa
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology and Critical Care Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022865