UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035943 |
|---|---|
| Receipt number | R000014586 |
| Scientific Title | The evaluation of time course of gastric fluid volume after drinking clear fluids in fasting state |
| Date of disclosure of the study information | 2019/02/20 |
| Last modified on | 2023/02/23 10:10:25 |
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Basic information
Public title
The evaluation of time course of gastric fluid volume after drinking clear fluids in fasting state
Acronym
The evaluation of gastric fluid volume in fasting state
Scientific Title
The evaluation of time course of gastric fluid volume after drinking clear fluids in fasting state
Scientific Title:Acronym
The evaluation of gastric fluid volume in fasting state
Region
| Japan |
Condition
Condition
patients for elective surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object is to clarify the regulating factors of gastric emptying flow rate of clear fluids in fasting state in healthy adult volunteers. Preoperative fasting is common procedures in patients for elective surgery. Actually it is revealed that gastric emptying flow rate of clear fluids differ from one to another. It depends on the contents of clear fluid. The goal is to serve safe and suitable clear fluids for the surgical patients by determining the regulating factors of gastric emptying flow rate of clear fluids.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gastric fluid volume after fasting, immediately after drinking clear fluid, and 30 min after drinking clear fluid.
Key secondary outcomes
gastric emptying flow rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
To drink 500 mL of normal saline
-> (3days for washing out)
-> To drink 500 mL of isovolume mixture of 5% glucose solution and normal saline
Interventions/Control_2
To drink 500 mL of isovolume mixture of 5% glucose solution and normal saline
-> (3days for washing out)
-> To drink 500 mL of normal saline
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy without gastroenterological disease
(2) Body weight is 40 kg and more. Body Mass Index is between 18 and 30 kg/m^2
(3) Obtained written informed consent
Key exclusion criteria
(1) Inability to examine Magnetic Resonance Imaging
(2) When the researcher evaluates that the candidate is not suitable for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chol |
| Middle name | |
| Last name | Kim |
Organization
Nippon Medical School
Division name
Department of Anesthesiology
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
ckim@nms.ac.jp
Public contact
Name of contact person
| 1st name | Chol |
| Middle name | |
| Last name | Kim |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Department of Anesthesia
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba
TEL
0476-99-1111
Homepage URL
ckim@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School Chiba Hokusoh Hospital
Department of Anesthesiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Clinical Imaging Center for Healthcare, Nippon Medical School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee, Nippon Medical School Chiba Hokusoh Hospital
Address
1715 Kamagari, Inzai, Chiba
Tel
0476-99-1111
n-yamauchi@nms.ac.jp
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
日本医科大学健診医療センター
(Clinical Imaging Center for Healthcare, Nippon Medical School)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 20 | 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
10
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It takes longer time to analyze than as expected.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No events have been observed.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 20 | Day |
Last modified on
| 2023 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014586
