UMIN-CTR Clinical Trial

Basic information
Public title	An association between intraoperative motor/ somatosensory evoked potential and anesthesia drugs
Acronym	An association between intraoperative motor evoked potential and anesthesia drugs
Scientific Title	An association between intraoperative motor/ somatosensory evoked potential and anesthesia drugs
Scientific Title:Acronym	An association between intraoperative motor evoked potential and anesthesia drugs
Region	Japan

Condition
Condition	Patients aged 20 years or older who undergo spinal surgery using MEP or SEP under general anesthesia.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We measure how much anesthetic agents used for general anesthesia affect the amplitude of motor evoked potential (MEP) or somatosensory Evoked Potentials (SEP).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in MEP and SEP
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	propofol 1-5
Interventions/Control_2	Sevoflurane 1-3%
Interventions/Control_3	Desflurane 1-3%
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patient with ASA 1-2 who is over 20 years old who undergoes spinal surgery using MEP under general anesthesia.
Key exclusion criteria	Patient twenty years or younger. Patient with poor general condition. Patients who can not measure the control value of MEP.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Hoshijima
Organization	Saitama Medical University Hospital
Division name	Anesthesiology
Zip code	350-0495
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL	049-276-1271
Email	hhoshi6@gmail.com

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Hoshijima
Organization	Saitama Medical University Hospital
Division name	Anesthesiology
Zip code	350-0495
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL	049-276-1271
Homepage URL
Email	hhoshi6@gmail.com

Sponsor
Institute	Saitama Medical University Hospital, Anesthesiology, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
Institute
Department

Funding Source
Organization	Saitama Medical University Hospital, Anesthesiology, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
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	Saitama Medical University Hospital
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
Tel	049-276-1271
Email	hhoshi6@gmail.com

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	2019 Year 04 Month 01 Day

Related information
URL releasing protocol	Unresearched
Publication of results	Unpublished

Result
URL related to results and publications	Unresearched
Number of participants that the trial has enrolled	0
Results	Unresearched
Results date posted	2022 Year 05 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Unresearched
Participant flow	Unresearched
Adverse events	Unresearched
Outcome measures	Unresearched
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2019 Year 04 Month 02 Day
Anticipated trial start date	2019 Year 04 Month 02 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	2018 Year 11 Month 14 Day
Last modified on	2022 Year 05 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039749