UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023684
Receipt No. R000027278
Scientific Title Changes in cerebral blood volume (CBV) and flow (CBF) during the induction of general anesthesia
Date of disclosure of the study information 2016/08/29
Last modified on 2018/08/20

* 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 Changes in cerebral blood volume (CBV) and flow (CBF) during the induction of general anesthesia
Acronym Cerebral blood volume and flow during the induction of anesthesia
Scientific Title Changes in cerebral blood volume (CBV) and flow (CBF) during the induction of general anesthesia
Scientific Title:Acronym Cerebral blood volume and flow during the induction of anesthesia
Region
Japan

Condition
Condition Patients scheduled to have general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the changes in CBV during the induction of general anesthesia by using new style near infrared spectroscopy, tNIRS-1 Simultaneously, to evaluate the changes in CBF by using the transcranial doppler. Data were obtained in inhalational(sevoflurane) and intravenous (propofol) anesthesia.
Basic objectives2 Others
Basic objectives -Others Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in CBV during induction of general anesthesia
Key secondary outcomes Relation between CBF and CBV during induction of general anesthesia

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with ASA1,2, who have general anesthesia in the of Hokkaido University Hospital
Key exclusion criteria 1 Patienst with intracranial disease
2 Patients with diseases for heart or great and carotid vessels
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Morimoto
Organization Hokkaido University Hospital
Division name Anesthesiology
Zip code
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Email morim2@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Morimoto
Organization Hokkaido University Hospital
Division name Anesthesiology
Zip code
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email morim2@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Anesthesiology
Institute
Department

Funding Source
Organization None
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
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
2016 Year 08 Month 29 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 Completed
Date of protocol fixation
2016 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 06 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Study period: until 20183.31

Patients who have general anesthesia in the urology department of Hokkaido University Hospital and meet the criteria

Observational items: Background, laboratory data, vital signs during operation, cerebral hemoglobin concentration (as an index of CBV), cerebral blood flow velocity

Management information
Registered date
2016 Year 08 Month 19 Day
Last modified on
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027278

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.