UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement serum concentration of ropivacaine during awake craniotomy to investigate appropriate amount of ropivacaine
Title of the study (Brief title)	Measurement serum concentration of ropivacaine during awake craniotomy to investigate appropriate amount of ropivacaine
Region	Japan

Condition
Condition	brain tumor which should be resected under awake craniotomy
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In awake craniotomy.measurement serum concentration of ropivacaine after scalp block and local injection(haedpin area, surgical incision area) ,and evaluate appropriate ropivacaine concentration and pain control.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of serum concentration of ropivacaine(at arterial blood),
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	We are going to use ropivacaine for local anesthesia upper 3.6mg/kg at awake craniotomy,and measure of serum concentration of ropivacaine(arterial blood) 15minites after injection
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	18 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are going to have the awake craniotomy at Nagoya university hospital. 1)Age 18yo to 70yo 2)ASA PS 1,2,3 3)Patient who agreed this research by informed consent and the document
Key exclusion criteria	1)Patients who don't agreed. 2)have a liver disfunction. 3)have a allergy for the ropivacaine and other local anesthetics. 4)have a disfunction of anticoagulants 5)have a severe respiratory disorder. 6)have a heart failure. 7)Other factor which patients can't be in candidate at this study decided by the doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Nishiwaki Kimitoshi
Organization	Nagoya university graduate school of medicine
Division name	Department of anesthesiology
Address	65 Tsurumaicho showa-ku nagoya city Aichi japan
TEL	052-744-2341
Email	nishi@med.nagoya-u.ac.jp

Public contact
Name of contact person	Sato Takehito
Organization	Nagoya university graduate school of medicine
Division name	Department of anesthesiology
Address	65 Tsurumaicho showa-ku nagoya city Aichi japan
TEL	052-744-2341
Homepage URL
Email	takesato@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya university
Institute
Department

Funding Source
Organization	Japanese Governmental office
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 09 Day
Anticipated trial start date	2018 Year 04 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 19 Day
Last modified on	2018 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035096