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

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 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


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

Value
https://center6.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