UMIN-CTR Clinical Trial

Basic information
Public title	The effects of desflurane and propofol on motor evoked potential in patients undergoing spine surgery
Acronym	The effect of desflurane on motor evoked potential
Scientific Title	The effects of desflurane and propofol on motor evoked potential in patients undergoing spine surgery
Scientific Title:Acronym	The effect of desflurane on motor evoked potential
Region	Japan

Condition
Condition	Patients with ASA status 1 or 2, who are more than or equal to 20 years old and undergo spine surgery under motor evoked potential (MEP) monitoring
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the suppressive effects of desflurane and propofol on MEP, and demonstrate the safety of desflurane in adult patienst undergoing spine surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The intensity of electronic stimulation at first MEP evaluation
Key secondary outcomes	MEP amplitude at first evaluation The intensity of electronic stimulation and MEP amplitude after first MEP evaluation The frequency of MEP amplitude reduction or disappearance after first MEP evaluation The number of patients who presented MEP reduction or disappearance during operation and paralysis after operation Time to extubation from the end of surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intervention: General anesthesia using desflurane(0.5-1.5MAC)
Interventions/Control_2	Control: General anesthesia using propofol(Target controlled infusion:1.5 -4.0 microgram/ml)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient with ASA status 1 or 2, who are more than or equal to 20 years old and undergo spine surgery
Key exclusion criteria	Patients with past history or family history of malignant hyperthermia Patients with allergy to desflurane or propofol Patients with paralysis of upper or lower limbs before surgery
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Morisaki
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	morisaki@z8.keio.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Suzuki
Organization	Tokai University School of Medicine
Division name	Department of Anesthesiology
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa, Japan
TEL	0463-93-1121
Homepage URL
Email	takeshi-su@a7.keio.jp

Sponsor
Institute	Department of Anesthesiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Keio University School of Medicine
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	Ethics committee, Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	03-5363-3611
Email	med-rinri-jimu@adst.keio.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	慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 18 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	Terminated
Date of protocol fixation	2018 Year 08 Month 30 Day
Date of IRB	2018 Year 09 Month 08 Day
Anticipated trial start date	2018 Year 09 Month 19 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 16 Day
Last modified on	2021 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038951