UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020132 |
|---|---|
| Receipt number | R000023254 |
| Scientific Title | The effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction. |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2017/12/15 16:28:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction.
Acronym
Efficacy of preoperative oral rehydration therapy
Scientific Title
The effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction.
Scientific Title:Acronym
Efficacy of preoperative oral rehydration therapy
Region
| Japan |
Condition
Condition
The patients who plan to undergo resection of colorectal cancer.
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effect of preoperative oral rehydration therapy on circulatory collapse during anesthetic induction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of SVV, SVI after epidural administration of 2% lidocaine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
taking rehydration solution at most 1000ml two hours prior to surgery
Interventions/Control_2
control
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who plan to undergo resection of colorectal cancer.
Key exclusion criteria
Gastrointestinal dysfunction due to functional, non-mechanical inhibition of propulsive bowel activity
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makiko Komori |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Anesthesiology
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL
81-3-3810-1111
komorim@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Ichikawa |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Department of Anesthesiology
Zip code
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL
81-3-3810-1111
Homepage URL
htwfx872@yahoo.co.jp
Sponsor or person
Institute
Tokyo Women's Medical University Medical Center East
Institute
Department
Personal name
Funding Source
Organization
Budget for Anesthesiology department
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 09 | Day |
Last modified on
| 2017 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023254
