UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026922
Receipt number R000030883
Scientific Title Comparison of hemodynamic changes between propofol and thiopental during general anesthesia induction
Date of disclosure of the study information 2017/04/10
Last modified on 2019/10/12 10:25:30

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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 or person

Institute

Osaka City University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030883


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name