UMIN-CTR Clinical Trial

Basic information
Public title	The effect of remimazolam on sensory evoked potentials
Acronym	The effect of remimazolam on sensory evoked potentials
Scientific Title	The effect of remimazolam on sensory evoked potentials
Scientific Title:Acronym	The effect of remimazolam on sensory evoked potentials
Region	Japan

Condition
Condition	Patients undergoing neurosurgery under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare the sensory evoked potentials (visual evoked potential, somatosensory evoked potential, auditory brainstem response) under remimazolam anesthesia with sensory evoked potentials under propofol anesthesia.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amplitudes of visual evoked potentials and somatosensory evoked potentials. The latency of auditory brainstem response.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing neurosurgery under general anesthesia.
Key exclusion criteria	Patients with impaired consciousness
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Ryusuke Middle name Last name Tanaka
Organization	Ina central hospital
Division name	Division of anesthesiology
Zip code	396-8555
Address	1313-1 Koshiroukubo, Ina City, Nagano 396-8555, Japan
TEL	0265723121
Email	rtanaka@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Ryusuke Middle name Last name Tanaka
Organization	Ina central hospital
Division name	Division of anesthesiology
Zip code	396-8555
Address	1313-1 Koshiroukubo, Ina City, Nagano 396-8555, Japan
TEL	0265723121
Homepage URL
Email	rtanaka@shinshu-u.ac.jp

Sponsor
Institute	Ina central hospital
Institute
Department

Funding Source
Organization	None
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	Ethical review board of Ina central hospital
Address	1313-1 Koshiroukubo, Ina City, Nagano 396-8555, Japan
Tel	0265723121
Email	info@inahp.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	伊那中央病院

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	10
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	2020 Year 08 Month 19 Day
Date of IRB	2020 Year 08 Month 19 Day
Anticipated trial start date	2020 Year 11 Month 17 Day
Last follow-up date	2022 Year 11 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 11 Month 17 Day
Last modified on	2021 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048477