UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026446 |
|---|---|
| Receipt number | R000030384 |
| Scientific Title | study of changes in body water content and circulation dynamics during general anesthesia in patients with special needs |
| Date of disclosure of the study information | 2017/03/08 |
| Last modified on | 2018/03/13 07:33:45 |
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Basic information
Public title
study of changes in body water content and circulation dynamics during general anesthesia in patients with special needs
Acronym
study of changes in body water content and circulation dynamics during general anesthesia in patients with special needs
Scientific Title
study of changes in body water content and circulation dynamics during general anesthesia in patients with special needs
Scientific Title:Acronym
study of changes in body water content and circulation dynamics during general anesthesia in patients with special needs
Region
| Japan |
Condition
Condition
Autism, schizophrenia, cerebral palsy, mental retardation
Classification by specialty
| Neurology | Pediatrics | Psychiatry |
| Anesthesiology | Oral surgery | Operative medicine |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are several effects on body water content and circulation dynamics during general anesthesia. The purpose of this study is to explore the causal relationship between perioperative body water content, circulatory fluctuation and postoperative complications in special needs patients who require general anesthesia and other patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in body water content (extracellular fluid, muscle mass, fat mass), circulation dynamics (heart rate, blood pressure), postoperative respiratory complications
Key secondary outcomes
Patient background (sex, height, weight, BMI, current medical history, past history), operation time, anesthesia time, used anesthetic, absolute drinking time
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
| 16 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient scheduled for dental oral surgery to manage general anesthesia in our department
Patients who are diagnosed with autism, schizophrenia, cerebral palsy, or mental retardation.
Patients aged 16 to 60 in the American Society of Anesthesiology-Physical Status (ASA-PS) 1-2.
Patients who have obtained prior written consent
Key exclusion criteria
Patients with advanced heart (obvious heart failure and arrhythmia) disorder
Serious respiratory disease patients
Other patients judged unsuitable by other research doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsukamoto Masanori |
Organization
Kyushu university
Division name
Department of dental anesthesiology
Zip code
Address
Higashi-ku, Fukuoka Maidashi 3-1-1
TEL
092-642-6480
tsukamoto@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukamoto Masanori |
Organization
Kyushu university
Division name
Department of dental anesthesia
Zip code
Address
Higashi-ku, Fukuoka Maidashi 3-1-1
TEL
092-642-6480
Homepage URL
tsukamoto@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 03 | Month | 08 | 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
| 2016 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no special instruction
Management information
Registered date
| 2017 | Year | 03 | Month | 07 | Day |
Last modified on
| 2018 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030384
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