UMIN-CTR Clinical Trial

Basic information
Public title	Pharmacokinetics and pharmacodynimics of intravenous acetaminophen in Japanese surgical patients
Acronym	Pharmacology of intravenous acetaminophen
Scientific Title	Pharmacokinetics and pharmacodynimics of intravenous acetaminophen in Japanese surgical patients
Scientific Title:Acronym	Pharmacology of intravenous acetaminophen
Region	Japan

Condition
Condition	Patients who undergo surgeries under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To test the hypothesis that the effect of intravenous acetaminophen lasts longer when the drug is administered with longer duration than with shorter duration and to construct a population pharmacokinetic model of intravenous acetaminophen
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analgesics required postoperatively
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Control (no acetaminophen) (Pharmacokinetic analysis will be performed with 3 groups below; no control group is required)
Interventions/Control_2	15 min of duration of administration of intravenous acetaminophen
Interventions/Control_3	60 min of duration of administration of intravenous acetaminophen
Interventions/Control_4	120 min of duration of administration of intravenous acetaminophen
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	ASA 1,2, and 3 Patients who undergo elective surgeries
Key exclusion criteria	1.Known allergy to acetaminophen 2.Psychoneurotic disorders 3.Psychiatric pharmacotherapy 4.Chronic use of ACET, NSAIDs or opioids 5.Women who were pregnant or breast-feeding 6.Anemia 7.Liver or advanced renal dysfunction 8.Those who were considered inadequate
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Masahiro Middle name Last name Murakawa
Organization	Fukushima Medical University
Division name	Anesthesiology
Zip code	9601295
Address	1 Hikarigaoka, Fukusima City, Fukushima
TEL	0245471342
Email	masui@fmu.ac.jp

Public contact
1st name of contact person	1st name Shinju Middle name Last name Obara
Organization	Fukushima Medical University
Division name	Anesthesiology
Zip code	9601295
Address	1 Hikarigaoka, Fukusima City, Fukushima
TEL	0245471342
Homepage URL
Email	masui@fmu.ac.jp

Sponsor
Institute	Anesthesiology, Fukushima Medical University
Institute
Department

Funding Source
Organization	Anesthesiology, Fukushima 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	Fukushima Medical University Ethics Committee
Address	1 Hikarigaoka, Fukushima City, Fukushima
Tel	0245471111
Email	rs@fmu.ac.jp

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	2014 Year 03 Month 14 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	60
Results	Using 185 datapoints from 12 patients, the pharmacokinetics of i.v. acetaminophen were described by a two compartment model with weight as a covariate. The pharmacokinetic model of i.v. acetaminophen reported by Wurthwein et al.(Eur J Clin Pharmacol.2005;60:883) worked well. Above pharmacokinetic analysis was published as a final result. (J Anesth, DOI 10.1007/s00540_017_2358_7)
Results date posted	2019 Year 03 Month 11 Day
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	2014 Year 03 Month 13 Day
Date of IRB	2014 Year 03 Month 13 Day
Anticipated trial start date	2014 Year 03 Month 17 Day
Last follow-up date	2018 Year 12 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 03 Month 14 Day
Last modified on	2019 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015671