UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of bolus administration of ketamine on electrical transcranial motor-evoked potential
Title of the study (Brief title)	Effect of bolus administration of ketamine on motor evoked potential
Region	Japan

Condition
Condition	adolescent idiopathic scoliosis
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of the effect of bolus administration of ketamine on motor-evoked potential
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Minimum value of amplitude of motor-evoked potential during 10 minites after bolus administration of ketamine
Key secondary outcomes	latency of motor evoked potential differences between each muscles

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	intravenous administration of ketamine dose: 1 mg/kg (0.1 ml/kg) before surgery
Interventions/Control_2	intravenous administration of saline dose: 0.1 ml/kg before surgery
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	12 years-old <=
Age-upper limit	18 years-old >=
Gender	Female
Key inclusion criteria	Adolescent idiopathic scoliosis females who undergo posterior spinal fusion
Key exclusion criteria	gender:male age: less than 11 or more than 19 years old neurological abnormality congenital scolisis contraindication of ketamine predicted difficult airway allergy for drugs patients who cannot speak Japanese patients who do not or cannot consent
Target sample size	20

Research contact person
Name of lead principal investigator	Kenta Furutani
Organization	Niigata University
Division name	Anesthesiology
Address	1-757, Asahimachi-Dori, Chuo-ku, Niigata
TEL	025-227-2328
Email	kenta-f@med.niigata-u.ac.jp

Public contact
Name of contact person	Kenta Furutani
Organization	Niigata University Medical and Dental Sciences
Division name	Anesthesiology
Address	1-757, Asahimachi-Dori, Chuo-ku
TEL	025-227-2328
Homepage URL
Email	kenta-f@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	Niigata University
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	新潟大学医歯学総合病院（新潟県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 08 Day
Anticipated trial start date	2016 Year 05 Month 20 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	2016 Year 05 Month 18 Day
Last modified on	2017 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025617