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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016426
Receipt No. 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

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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
Email 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
Email kido@m.tohoku.ac.jp

Sponsor
Institute Dept. of dental anesthesia and pain management, Tohoku Univ. Hosp.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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