UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	study of changes in body water content and circulation dynamics during general anesthesia in patients with special needs
Title of the study (Brief title)	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	Tsukamoto Masanori
Organization	Kyushu university
Division name	Department of dental anesthesiology
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	Tsukamoto Masanori
Organization	Kyushu university
Division name	Department of dental anesthesia
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030384