UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007807 |
|---|---|
| Receipt number | 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 12:35:10 |
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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
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
Sponsor or person
Institute
Department of Anesthesiology Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009194
