UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of hemodynamic changes between propofol and thiopental during general anesthesia induction
Acronym	Comparison of hemodynamic changes between propofol and thiopental during general anesthesia induction
Scientific Title	Comparison of hemodynamic changes between propofol and thiopental during general anesthesia induction
Scientific Title:Acronym	Comparison of hemodynamic changes between propofol and thiopental during general anesthesia induction
Region	Japan

Condition
Condition	not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare hemodynamic changes between propofol and thiopental during general anesthesia induction.
Basic objectives2	Others
Basic objectives -Others	investigation of the influence of aging
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	decrease in mean arterial blood pressure during general anesthesia induction
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	general anesthesia induction with propofol
Interventions/Control_2	general anesthesia induction with thiopental
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	95 years-old >
Gender	Male and Female
Key inclusion criteria	patients undergoing scheduled surgery
Key exclusion criteria	patients with ASA-PS class 3 or more.
Target sample size	72

Research contact person
Name of lead principal investigator	1st name Tadashi Middle name Last name Matsuura
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Anesthesiology
Zip code	545-8586
Address	1-5-7, Asahi-machi, Abeno-ku, Osaka city, Japan
TEL	81-6-6645-2186
Email	t.matsuura@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Tadashi Middle name Last name Matsuura
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Anesthesiology
Zip code	545-8586
Address	1-5-7, Asahi-machi, Abeno-ku, Osaka city, Japan
TEL	81-6-6645-2186
Homepage URL
Email	t.matsuura@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University
Institute
Department

Funding Source
Organization	Osaka City University
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	Osaka City University Hospital Certified Review Board
Address	1-5-7, Asahi-machi, Abeno-ku, Osaka city, Japan
Tel	06-6645-3447
Email	k.takami@med.osaka-cu.ac.jp

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 04 Month 10 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	72
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 06 Month 21 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 31 Day
Date of IRB	2017 Year 03 Month 28 Day
Anticipated trial start date	2017 Year 04 Month 10 Day
Last follow-up date	2019 Year 04 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 04 Month 10 Day
Last modified on	2019 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030883