UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026446
Receipt No. 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

* 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 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
Email 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
Email tsukamoto@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030384

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.