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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035453
Receipt No. R000040384
Official scientific title of the study The effect of preoperative oral carbohydrate administration on patients with cesarean section under epidural anesthesia
Date of disclosure of the study information 2019/01/05
Last modified on 2019/01/14

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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

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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