UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of preoperative oral carbohydrate administration on patients with cesarean section under epidural anesthesia
Title of the study (Brief title)	The effect of preoperative oral carbohydrate administration on patients with cesarean section under epidural anesthesia
Region	Asia(except Japan)

Condition
Condition	Pregnancy
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study assesses thirst, hunger, anxiety, and safety of patents with cesarean section under epidural anesthesia after 2 hours fasting for carbohydrate administration. It also investigates the effects of carbohydrate administration on postoperative metabolic stress of patients.
Basic objectives2	Others
Basic objectives -Others	The study assesses the effect of carbohydrate administration on thirst, hunger, anxiety, safety and metabolic stress
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Efficacy The patients complete visual analog scales in terms of the thirst, hunger, and anxiety leve. Insulin resistance was calculated by the values of blood glucose and insulin which were assessed before administration and after the surgery. 2. Safety The gastric antral cross-sectional areas were recorded by the ultrasonography. Summarizing and aggregation of number and frequency of all adverse events occurring.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver Other
Interventions/Control_1	Fasting for 8 hours before surgery
Interventions/Control_2	Fasting for 6 hours until 2h before surgery, patients in the CHO group ingested 300ml of a clear carbohydrate-rich drink
Interventions/Control_3	The Placebo group consumed 300ml flavoured water fasting for 6 hours until 2h before surgery
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	25 years-old <=
Age-upper limit	35 years-old >=
Gender	Female
Key inclusion criteria	with elective cesarean section
Key exclusion criteria	patients with gestational diabetes hypertension and other gestational diseases patients suffered liver and kidney injury with coagulation dysfunction patients who can not receive epidural anesthesia
Target sample size	75

Research contact person
Name of lead principal investigator	Yuan Shi
Organization	General Hospital of Tianjin Medical University
Division name	Department of Anesthesiology
Address	No. 154 Anshan Road, Heping District, Tianjin 300052, PR China
TEL	8618649020878
Email	shiyuan_sy@126.com

Public contact
Name of contact person	Yuan Shi
Organization	General Hospital of Tianjin Medical University
Division name	Department of Anesthesiology
Address	No. 154 Anshan Road, Heping District, Tianjin 300052, PR China
TEL	8618649020878
Homepage URL
Email	shiyuan_sy@126.com

Sponsor
Institute	Tianjin Institute of Anesthesiology
Institute
Department

Funding Source
Organization	Tianjin Institute of Anesthesiology
Organization
Division
Category of Funding Organization	Government offices of other countries
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	General Hospital of Tianjin Medical University(China)

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 05 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2019 Year 01 Month 04 Day
Anticipated trial start date	2019 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2019 Year 01 Month 12 Day
Date analysis concluded	2019 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 05 Day
Last modified on	2019 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040384