UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between end-tidal desflurane concentration and threshold current of motor-evoked potential(MEP) under general anesthesia with propofol and remifentanil
Acronym	The relationship between end-tidal desflurane concentration and threshold current of motor-evoked potential(MEP)
Scientific Title	The relationship between end-tidal desflurane concentration and threshold current of motor-evoked potential(MEP) under general anesthesia with propofol and remifentanil
Scientific Title:Acronym	The relationship between end-tidal desflurane concentration and threshold current of motor-evoked potential(MEP)
Region	Japan

Condition
Condition	patients undergoing spine surgery
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the relationship between concentration of end-tidal desflurane and MEP threshold current under general anesthesia.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Desflurane is combined at end-tidal concentration of 1, 2, 3 and 4% with propofol and remifentanil for general anesthesia and MEP threshold current is measured respectively after five minutes steady state.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Desflurane is combined at end-tidal concentration of 1, 2, 3 and 4% with propofol and remifentanil for general anesthesia and MEP threshold current is measured respectively.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing spine surgery
Key exclusion criteria	Patients with motor palarysis Patients with comorbidity American Society of Anesthesiologists physical status(ASA-PS)3 or more Patients whom investigators consider to be ineligible
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name TAKEHIKO Middle name Last name NAGAOKA
Organization	Shin-yurigaoka general hospital
Division name	Anesthesia
Zip code	2150026
Address	255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL	0443229991
Email	takeitezzz@gmail.com

Public contact
1st name of contact person	1st name TAKEHIKO Middle name Last name NAGAOKA
Organization	Shin-yurigaoka General Hospital
Division name	Anesthesia
Zip code	2150026
Address	255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL	0443229991
Homepage URL
Email	takeitezzz@gmail.com

Sponsor
Institute	Shin-yurigaoka general hospital
Institute
Department

Funding Source
Organization	Our institution
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shin-yurigaoka General Hospital
Address	255 furusawa-toko, Asao, Kawasaki, Kanagawa
Tel	0443229991
Email	tadashi.kanbe@mt.strins.or.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	2016 Year 05 Month 10 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	Enrolling by invitation
Date of protocol fixation	2014 Year 04 Month 01 Day
Date of IRB	2014 Year 10 Month 27 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2021 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 10 Day
Last modified on	2019 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025197