UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019912 |
|---|---|
| Receipt number | R000008410 |
| Scientific Title | Postoperative Pain Management After General Anesthesia using Remifentanil |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2017/05/26 11:36:25 |
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Basic information
Public title
Postoperative Pain Management After General Anesthesia using Remifentanil
Acronym
Remifentanil and Pain Management
Scientific Title
Postoperative Pain Management After General Anesthesia using Remifentanil
Scientific Title:Acronym
Remifentanil and Pain Management
Region
| Japan |
Condition
Condition
Minor oral and maxillofacial surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether postoperative pain score is affected with or without transition from remifentanil to morphine after oral and maxillofacial surgical procedures
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post operative pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Morphine for postoperative pain
Interventions/Control_2
Placebo for postoperative pain
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Minor oral and maxillofacial surgical patients
Key exclusion criteria
Patients with a history of adverse reactions to opiates, a history of postoperative nausea and vomiting, or chronic pain
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoki Inoue |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
Address
840 Shijo-cho Kashihara Nara
TEL
0744-22-3051
seninoue@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoki Inoue |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
Address
840 Shijo-cho Kashihara Nara
TEL
0744-22-3051
Homepage URL
seninoue@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 24 | 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
| 2010 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | 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
| 2015 | Year | 11 | Month | 24 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008410
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
