UMIN-CTR Clinical Trial

Basic information
Public title	pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen
Acronym	pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen
Scientific Title	pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen
Scientific Title:Acronym	pharmacokinetics and pharmacodynamics study of intraveneous acetaminophen
Region	Japan

Condition
Condition	Patients who undergo head neck and oral surgery without nerve block or epidural anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate impact of differences in the administration rate of acetaminophen intraveneous drug and examine the relationship between pharmacokinetics and pharmacodynamics
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Blood concentration of acetaminophen
Key secondary outcomes	VRS VAS NRS

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	ASA 1 and 2 Adult patient with good condition
Key exclusion criteria	1.History of allergy to acetaminophen 2.History of aspirin asthma 3.Oral use of carbamazepine/phenobarbital/phenytoin/primidone/rifampicin 4.Psychoneurotic disorders 5.Psychiatric pharmacotherapy 6.Liver or advanced renal dysfunction 7.Alcohol drinkers and adddiction patient 8.Pregnant woman/breast-feeding 9.Those who were considered inadequate
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Tomoko Middle name Last name Suzuki
Organization	Tohoku University
Division name	Department of Anesthesiology and Perioperative Medicine
Zip code	980-8574
Address	1-1 seiryoumachi aobaku sendai miyagi
TEL	0227177321
Email	tomoko.suzuki.r2@dc.tohoku.ac.jp

Public contact
Name of contact person	1st name Tomoko Middle name Last name Suzuki
Organization	Tohoku University
Division name	Department of Anesthesiology and Perioperative Medicine
Zip code	980-8574
Address	1-1 seiryoumachi aobaku sendai miyagi
TEL	0227177321
Homepage URL
Email	tomoko.suzuki.r2@dc.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Sendai Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tohoku University
Address	1-1 Seiryoumachi Aobaku Sendai Miyagi Japan
Tel	0227177321
Email	tomoko.suzuki.r2@dc.tohoku.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	29-55 20-64
Org. issuing International ID_1	National Hospital Organization Sendai Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	仙台医療センター(宮城県)

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	51
Results	As a result of examining the results of NRS in 3 groups and postoperative analgesics and the characteristics of the blood concentration transition curve, when intravenous APAP 1000 mg is used intraoperatively and postoperatively, the analgesic effect was high with the administration method that combined rapid single administration and continuous administration.
Results date posted	2021 Year 04 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy adult patients undergoing minor oral surgery under general anesthesia at Sendai Medical Center (American Society of Anesthesia Preoperative Status Classification ASA physical status I-II)
Participant flow	Tohoku University Ethics Committee and National Hospital Organization Sendai Medical Center Ethics Committee after approval, oral and written explanations with consent, the patient himself signed the consent form in writing.
Adverse events	no
Outcome measures	Use of NRS and postoperative analgesics up to 240 minutes after dosing and Cmax, tmax, AUC, effective blood concentration arrival time, effective blood concentration maintenance time according to the drawn plasma concentration transition curve.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 23 Day
Date of IRB	2017 Year 10 Month 23 Day
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry	2021 Year 11 Month 30 Day
Date trial data considered complete	2021 Year 11 Month 30 Day
Date analysis concluded	2021 Year 11 Month 30 Day

Other
Other related information	Observe intravenous acetaminophen blood concentration and analgesic effect after acetaminophen infusion

Management information
Registered date	2017 Year 11 Month 16 Day
Last modified on	2021 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034203