UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of hazardous fluctuations in blood pressure at induction of general anesthesia by propofol in non-cardiac surgery
Title of the study (Brief title)	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	Sumio Hoka
Organization	Kyushu University
Division name	Department of anesthesiology and critical care medicine
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	Sho Kawasaki
Organization	Kyushu University
Division name	Department of anesthesiology and critical care medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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