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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011975
Receipt No. R000013989
Scientific Title Evaluation of optimal dosage of anesthetic
Date of disclosure of the study information 2013/10/10
Last modified on 2020/03/10

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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

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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