UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003901 |
|---|---|
| Receipt number | R000004612 |
| Scientific Title | Evaluation of the required concentration of dexmedetomidine after abdominal aorta aneurysm surgery with fentanyl- or remifentanil-based anesthetic management |
| Date of disclosure of the study information | 2010/07/14 |
| Last modified on | 2010/07/11 23:16:32 |
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Basic information
Public title
Evaluation of the required concentration of dexmedetomidine after abdominal aorta aneurysm surgery with fentanyl- or remifentanil-based anesthetic management
Acronym
Evaluation of the required plasma concentration of dexmedetomidine after abdominal aorta aneurysm surgery
Scientific Title
Evaluation of the required concentration of dexmedetomidine after abdominal aorta aneurysm surgery with fentanyl- or remifentanil-based anesthetic management
Scientific Title:Acronym
Evaluation of the required plasma concentration of dexmedetomidine after abdominal aorta aneurysm surgery
Region
| Japan |
Condition
Condition
Abdominal aorta aneurysm
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Since change from traditional perioperative management to a new one with a new drug is thought to make the required concentration of the sedative drug in post-operative management change, we evaluate the actual required concentration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma concentration of dexmedetomidine and outcome
Key secondary outcomes
Hemodynamics, respiratory condition, sedative condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fentanyl is used for analgesia during surgery
Interventions/Control_2
Remifentanil is used for analgesia during surgery
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient undergoing abdominal aorta aneurysm surgery with an age of 20 years or more.
Key exclusion criteria
Exclusion criteria were severe cardiovascular disease and concurrent systemic disorders. Patients with arrhythmias such as atrial fibrillation or disturbance in the conduction system and those receiving alpha-methyldopa or clonidine treatment were also excluded from this study.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Kunisawa |
Organization
Asahikawa Medical College
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido
TEL
0166-68-2583
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Kunisawa |
Organization
Asahikawa Medical College
Division name
Anesthesiology and Critical Care Medicine
Zip code
Address
2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido
TEL
0166-68-2583
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical College.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
旭川医科大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The required dexmedetomidine concentration in the remifentanil group was triple that in the fentanyl group. However, the required time to extubation was shorter and urine output was larger in the remifentanil group than those in the fentanyl group. (Presented at The 28th Annual Meeting of Japan Society for Clinical Anesthesia, Kyoto, November 22, 2008.)
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
| 2006 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 11 | Day |
Last modified on
| 2010 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004612
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
