UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035453 |
|---|---|
| Receipt number | R000040384 |
| Scientific Title | 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 16:15:11 |
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Basic information
Public title
The effect of preoperative oral carbohydrate
administration on patients with cesarean section under epidural anesthesia
Acronym
The effect of preoperative oral carbohydrate
administration on patients with cesarean section under epidural anesthesia
Scientific Title
The effect of preoperative oral carbohydrate
administration on patients with cesarean section under epidural anesthesia
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yuan Shi |
Organization
General Hospital of Tianjin Medical University
Division name
Department of Anesthesiology
Zip code
Address
No. 154 Anshan Road, Heping District, Tianjin 300052, PR China
TEL
8618649020878
shiyuan_sy@126.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuan Shi |
Organization
General Hospital of Tianjin Medical University
Division name
Department of Anesthesiology
Zip code
Address
No. 154 Anshan Road, Heping District, Tianjin 300052, PR China
TEL
8618649020878
Homepage URL
shiyuan_sy@126.com
Sponsor or person
Institute
Tianjin Institute of Anesthesiology
Institute
Department
Personal name
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)
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
General Hospital of Tianjin Medical University(China)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040384
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
