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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007807
Receipt No. R000009194
Scientific Title Investigation into the effect of flurbiprofen axetil on the suppression of circulation due to remifentanil when introducing general anesthesia
Date of disclosure of the study information 2012/04/21
Last modified on 2012/05/24

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Basic information
Public title Investigation into the effect of flurbiprofen axetil on the suppression of circulation due to remifentanil when introducing general anesthesia
Acronym Investigation into the effect of flurbiprofen axetil on the suppression of circulation due to remifentanil when introducing general anesthesia
Scientific Title Investigation into the effect of flurbiprofen axetil on the suppression of circulation due to remifentanil when introducing general anesthesia
Scientific Title:Acronym Investigation into the effect of flurbiprofen axetil on the suppression of circulation due to remifentanil when introducing general anesthesia
Region
Japan

Condition
Condition Patients with ASA1 to 2 that undergo elective surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An investigation is conducted regarding whether or not the suppression of circulation due to remifentanil may be prevented by administering flurbiprofen axetil prior to introducing anesthesia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood pressure
Heart rate
Key secondary outcomes PGEM
2,3-dinor-6-keto ProstaglandinF1alpha

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group with flurbiprofen axetil administered prior to introducing anesthesia

Flurbiprofen axetil is administered prior to introducing general anesthesia and general anesthesia is conducted using remifentanil as well as sevoflurane.
Interventions/Control_2 The group with flurbiprofen axetil
administered prior to commencing surgery

General anesthesia is conducted using remifentanil as well as sevoflurane, and flurbiprofen axetil is administered prior to commencing surgery.
Interventions/Control_3 The group with flurbiprofen axetil
administered prior to end of surgery

General anesthesia is conducted using remifentanil as well as sevoflurane, and flurbiprofen axetil is administered prior to end of g surgery.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with ASA1 to 2 that undergo elective surgery under general anesthesia

Key exclusion criteria Patients exhibiting poorly controlled hypertension prior to surgery
Patients with cardiovascular complications such as arrhythmia, abnormal ECG prior to surgery
Patients in which epidural anesthesia is concomitantly used upon general anesthesia
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nozomi Majima
Organization Osaka Medical College Hospital
Division name Deparetment of Anesthesiology
Zip code
Address 2-7 Daigaku-machi Takatsuki,Osaka
TEL 072-683-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nozomi Majima
Organization Osaka Medical College Hospital
Division name Deparetment of Anesthesiology
Zip code
Address 2-7 Daigaku-machi Takatsuki,Osaka
TEL 072-683-1221
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology Osaka Medical College
Institute
Department

Funding Source
Organization Department of research funding,
Department of Anesthesiology Osaka
Medical College
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2012 Year 04 Month 21 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 Completed
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 21 Day
Last modified on
2012 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009194

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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