UMIN-CTR Clinical Trial

Basic information
Public title	Predictive performance of target controlled infusion system in head down position
Acronym	Propofol pharmacokinetics in head down position
Scientific Title	Predictive performance of target controlled infusion system in head down position
Scientific Title:Acronym	Propofol pharmacokinetics in head down position
Region	Japan

Condition
Condition	Diseases which require head down position with pneumoperitoneum during surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the predictive performance of target controlled infusion system in head down position
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bias (median prediction error) and accuracy (median absolute prediction error) of predicted propofol concentrations compared to measured blood propofol concentrations. Blood samples will be collected during general anesthesia for surgery. Statistical analysis will be performed after the collection of a certain number of samples.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Propofol administration using target controlled infusion system targeting 3 mcg/ml during anesthesia for surgery
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	50 years-old <=
Age-upper limit	75 years-old >=
Gender	Male
Key inclusion criteria	Male patients who are scheduled to undergo elective surgery in head down position and provided written informed consent whose physical status are American Society of Anesthesiologists classification 1 or 2.
Key exclusion criteria	Exclusion criteria includes known allergy to propofol; psychoneurotic disorders; psychiatric pharmacotherapy; chronic use of NSAIDs or opioids; cirrhosis; anemia (hemoglobin <8 g/dL); and those who were considered inadequate.
Target sample size	15

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 Fukushima 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	Surgical Operation Department
Zip code	9601295
Address	1 Hikarigaoka Fukushima City, Fukushima
TEL	0245471342
Homepage URL
Email	masui@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	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 Research Ethics Committee
Address	1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
Tel	0245471825
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	2017 Year 05 Month 22 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	15
Results
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	2017 Year 05 Month 09 Day
Date of IRB	2017 Year 04 Month 27 Day
Anticipated trial start date	2017 Year 05 Month 22 Day
Last follow-up date	2019 Year 02 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 22 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031256