UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059791 |
|---|---|
| Receipt number | R000068307 |
| Scientific Title | Examination of the relationship between fluid volume and bladder volume during general anesthesia |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/11 18:18:29 |
* 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
Examination of the relationship between fluid volume and bladder volume during general anesthesia
Acronym
Examination of the relationship between fluid volume and bladder volume during general anesthesia
Scientific Title
Examination of the relationship between fluid volume and bladder volume during general anesthesia
Scientific Title:Acronym
Examination of the relationship between fluid volume and bladder volume during general anesthesia
Region
| Japan |
Condition
Condition
Patients undergoing oral surgery under general anesthesia
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the relationship between bladder capacity and urge to urinate before and after general anesthesia using ultrasound equipment
Basic objectives2
Others
Basic objectives -Others
Assessment of the necessity of urinary catheterization during general anesthesia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the correlation between bladder capacity and postoperative urinary urgency
Key secondary outcomes
Evaluation of postoperative urinary urgency based on fluid administration volume, age, and complications
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing dental and oral surgery under general anesthesia.
Patients not expected to have an indwelling urinary catheter.
Key exclusion criteria
Patients with renal impairment.
Patients requiring fluid restriction (patients with poorly controlled heart failure or diabetes).
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | MIzuko |
| Middle name | |
| Last name | Ikeda |
Organization
Fukuoka Dental College
Division name
Section of Anesthesiology,Department of Diagnostics and& General Care,
Zip code
8140193
Address
2-15-1 Tamura,Sawara-ku, Fukuoka-shi, Fukuoka 814-0193.Japan.
TEL
08017136232
morinaga@fdcnet.ac.jp
Public contact
Name of contact person
| 1st name | saori |
| Middle name | |
| Last name | morinaga |
Organization
Fukuoka Dental College
Division name
Section of Anesthesiology,Department of Diagnostics and General Care
Zip code
8140193
Address
2-15-1 Tamura,Sawara-ku, Fukuoka-shi, Fukuoka 814-0193.Japan.
TEL
08017136232
Homepage URL
morinaga@fdcnet.ac.jp
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
Funding Source
Organization
The Japanese Dental Society of Anesthesiology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Gakuen IRB
Address
2-15-1 Tamura,Sawara-ku, Fukuoka-shi, Fukuoka 814-0193.Japan.
Tel
0928010425
shomu@fdcnet.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design: Cohort study
Subject recruitment method: All patients scheduled for surgery between November 2025 and December 2027 who meet the selection criteria
Management information
Registered date
| 2025 | Year | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068307
