UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of optimal dosage of anesthetic
Acronym	Evaluation of optimal dosage of anesthetic
Scientific Title	Evaluation of optimal dosage of anesthetic
Scientific Title:Acronym	Evaluation of optimal dosage of anesthetic
Region	Japan

Condition
Condition	arteriosclerosis obliterans ischemic heart disease valvular disease aneurysm of the aorta
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the optimal dosage of propofol and remifentanil at induction of anesthesia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood pressure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	remifentanil1.0ug/kg/min,propofol2ug/ml
Interventions/Control_2	remifentanil0.5ug/kg/min,propofol2ug/ml
Interventions/Control_3	remifentanil0.5ug/kg/min,propofol3ug/ml
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who were scheduled to undergo peripheral vascular bypass surgery for arteriosclerosis obliterans and patients who were scheduled to undergo cardiovascular surgery(coronary artery bypass grafting, valve replacement, or replacement of the aorta)
Key exclusion criteria	arrhythmia heart failure(EF<30%)
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toyama Yuki
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology&Critical care
Zip code
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido
TEL	0166682583
Email	toyama12@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Toyama Yuki
Organization	Asahikawa Medical University
Division name	Department of Anesthesiology&Critical care
Zip code
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido
TEL	0166682583
Homepage URL
Email	toyama12@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 10 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	Terminated
Date of protocol fixation	2013 Year 05 Month 20 Day
Date of IRB	2013 Year 07 Month 11 Day
Anticipated trial start date	2013 Year 10 Month 10 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 07 Day
Last modified on	2020 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013989