UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016426 |
|---|---|
| Receipt number | R000019077 |
| Scientific Title | Dose high dose remifentanil induce postoperative hyperalgesia? |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2019/01/17 07:52:50 |
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Basic information
Public title
Dose high dose remifentanil induce postoperative hyperalgesia?
Acronym
remifentanil induced hyperalgesia
Scientific Title
Dose high dose remifentanil induce postoperative hyperalgesia?
Scientific Title:Acronym
remifentanil induced hyperalgesia
Region
| Japan |
Condition
Condition
postoperative pain
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of continuous ketamine administration on postoperative hyperalgesia induced by high dose remifentanil.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analogue pain scale
Amount of supplemental anesthetics
Side effects of anesthetics
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
sham
Interventions/Control_2
ketamine administration
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
oral surgery
physical status 1 and 2
Key exclusion criteria
intracranial hypertension
taking pain killer
mental disease
alcoholism
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanta Kido |
Organization
Tohoku Univ. Hosp.
Division name
Dept. of dental anesthesia and pain management,
Zip code
Address
4-1Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-8420
kido@m.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanta Kido |
Organization
Tohoku Univ. Hosp.
Division name
Dept. of dental anesthesia and pain management,
Zip code
Address
4-1Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-8420
Homepage URL
kido@m.tohoku.ac.jp
Sponsor or person
Institute
Dept. of dental anesthesia and pain management, Tohoku Univ. Hosp.
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Remifentanil is associated with acute opioid tolerance that can lead to increased postoperative consumption of opioid analgesics. The purpose of this study was to determine whether a low dose of ketamine prevents remifentanil-induced acute opioid tolerance and affects the neutrophil-lymphocyte ratio (NLR), a newly recognized biomarker of in ambition.
High-dose intraoperative remifentanil induced postoperative acute opioid tolerance that was prevented by infusion of low-dose ketamine. Ketamine increased the postoperative NLR associated with decreased fentanyl requirement for postoperative pain control.
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
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 02 | Day |
Last modified on
| 2019 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019077
