UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022349
Receipt number R000025617
Scientific Title The effect of bolus administration of ketamine on electrical transcranial motor-evoked potential
Date of disclosure of the study information 2016/05/20
Last modified on 2017/11/27 19:45:29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The effect of bolus administration of ketamine on electrical transcranial motor-evoked potential

Acronym

Effect of bolus administration of ketamine on motor evoked potential

Scientific Title

The effect of bolus administration of ketamine on electrical transcranial motor-evoked potential

Scientific Title:Acronym

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

1st name
Middle name
Last name Kenta Furutani

Organization

Niigata University

Division name

Anesthesiology

Zip code


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

1st name
Middle name
Last name Kenta Furutani

Organization

Niigata University Medical and Dental Sciences

Division name

Anesthesiology

Zip code


Address

1-757, Asahimachi-Dori, Chuo-ku

TEL

025-227-2328

Homepage URL


Email

kenta-f@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

2016 Year 05 Month 08 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025617


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name