UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose high dose remifentanil induce postoperative hyperalgesia?
Title of the study (Brief title)	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	Kanta Kido
Organization	Tohoku Univ. Hosp.
Division name	Dept. of dental anesthesia and pain management,
Address	4-1Seiryo-machi, Aoba-ku, Sendai, Japan
TEL	022-717-8420
Email	kido@m.tohoku.ac.jp

Public contact
Name of contact person	Kanta Kido
Organization	Tohoku Univ. Hosp.
Division name	Dept. of dental anesthesia and pain management,
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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