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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027359
Receipt No. R000030485
Scientific Title Prediction of hazardous fluctuations in blood pressure at induction of general anesthesia by propofol in non-cardiac surgery
Date of disclosure of the study information 2017/05/16
Last modified on 2018/12/07

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Basic information
Public title Prediction of hazardous fluctuations in blood pressure at induction of general anesthesia by propofol in non-cardiac surgery
Acronym Establishment of the prediction formula of propofol during anesthesia induction in non-cardiac surgery
Scientific Title Prediction of hazardous fluctuations in blood pressure at induction of general anesthesia by propofol in non-cardiac surgery
Scientific Title:Acronym Establishment of the prediction formula of propofol during anesthesia induction in non-cardiac surgery
Region
Japan

Condition
Condition Patients underwent surgey under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the prediction formula to prevent hazardous fluctuations in blood pressure at induction of general anesthesia by propofol in non-cardiac surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fluctuations in blood pressure between before and after induction of general anesthesia
Key secondary outcomes

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 18 and older
general anesthesia induction using propofol
non-cardiac surgery
Key exclusion criteria emergency surgery
organ transplantation
rapid sequence or slow induction
intubation through a tracheotomy or nasal passage
multiple direct laryngoscopy
extra drug administration
insufficient description
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumio Hoka
Organization Kyushu University
Division name Department of anesthesiology and critical care medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL 092-642-5714
Email shoka@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sho Kawasaki
Organization Kyushu University
Division name Department of anesthesiology and critical care medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL 092-642-5714
Homepage URL
Email sho0806@kuaccm.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Department of anesthesiology and critical care medicine
Institute
Department

Funding Source
Organization none
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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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 05 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information finished

Management information
Registered date
2017 Year 05 Month 16 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030485

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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