UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006805 |
|---|---|
| Receipt number | R000008054 |
| Scientific Title | A randomized parallel-group controlled study for personalized postoperative pain management based on prediction of fentanyl requirements by genetic polymorphisms in patients undergoing orthognathic surgery |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2024/12/11 11:36:00 |
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Basic information
Public title
A randomized parallel-group controlled study for personalized postoperative pain management based on prediction of fentanyl requirements by genetic polymorphisms in patients undergoing orthognathic surgery
Acronym
A controlled study on efficacy of personalized postoperative pain management by determining genetic polymorphisms in patients undergoing orthognathic surgery
Scientific Title
A randomized parallel-group controlled study for personalized postoperative pain management based on prediction of fentanyl requirements by genetic polymorphisms in patients undergoing orthognathic surgery
Scientific Title:Acronym
A controlled study on efficacy of personalized postoperative pain management by determining genetic polymorphisms in patients undergoing orthognathic surgery
Region
| Japan |
Condition
Condition
Pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To inspect the effectiveness of personalized pain treatment, based on our pre-study which examined genetic polymorphisms associated with postoperative opioid requirements or intensity of postoperative pain in patients undergoing orthognathic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Predictability of Intravenous-Patient-controlled analgesia (IV-PCA) requirements for postoperative 24 h, patient's satisfaction, and/or composite endpoint including side effects
Key secondary outcomes
Intravenous-Patient-controlled analgesia (IV-PCA) requirements for postoperative 24 h, visual analog scale, side effects (heart rate, blood pressure, SpO2, breathing, sedation score)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Personalized dose : transitional opioid (fentanyl = dose predicted by polymorphisms) and IV-PCA dose (fentanyl = dose predicted by polymorphisms / 1injection) for postoperative 24 h
Interventions/Control_2
Normal dose : transitional opioid (fentanyl = 100mcg) and IV-PCA dose (fentanyl = 20mcg / 1injection) for postoperative 24 h
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo orthognathic surgery and agree to participate in the study with written informed consent
Key exclusion criteria
Patients less than 15 years and more than 60 years or those with severe complications
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Addictive Substance Project
Zip code
156-8506
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL
03-6834-2379(EXT-3825)
ikeda-kz@igakuken.or.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Addictive Substance Project
Zip code
156-8506
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL
03-6834-2379(EXT-3825)
Homepage URL
ikeda-kz@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Dental College Suidobashi Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Subjects Ethics Committee, Tokyo Metropolitan Institute of Medical Science
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
Tel
03-6834-2391
renkei@igakuken.or.jp
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 | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2044 | Year | 12 | 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
| 2011 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008054
