UMIN-CTR Clinical Trial

Basic information
Public title	Examination of differences in EEG frequency changes between inhalation anesthesia and total intravenous anesthesia
Acronym	Examination of differences in EEG frequency changes between inhalation anesthesia and total intravenous anesthesia
Scientific Title	Examination of differences in EEG frequency changes between inhalation anesthesia and total intravenous anesthesia
Scientific Title:Acronym	Examination of differences in EEG frequency changes between inhalation anesthesia and total intravenous anesthesia
Region	Japan

Condition
Condition	Patients undergoing surgery with general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effects of anesthetics on electroencephalogram(EEG) is very. The effect is depending on type of anesthetics. For example, sevoflurane, an inhaled anesthetics, increases proportion of EEG alpha wave compared to propofol, an intravenous anesthetics. This study aims to investigate effect of desflurane, another inhaled anesthetics, and propofol on frequency distribution of EEG.
Basic objectives2	Others
Basic objectives -Others	Some patient develop delirium after surgery with general anesthesia. Among various causative factor, anesthetics itself could be responsible for development of the delirium. We hypothesized analysis of character of EEG frequency proportion by various anesthetics could predict potency of delirium development.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences in EEG frequency distribution between desflurane and propofol from the introduction of general anesthesia to the start of surgery
Key secondary outcomes	Perioperative psychiatric and general physio-pathological condition including liver, kidney etc

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Desflurane
Interventions/Control_2	Propofol
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 surgery with general anesthesia
Key exclusion criteria	Patients with skin lesions on the forehead, where the BIS monitor is attached, neurosurgery, patients with cerebrovascular complications, patients with psychiatric disorders, patients with opioid addiction
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Kushikata
Organization	Hirosaki University Graduate School of Medicine
Division name	Anesthesiology
Zip code	036-8562
Address	Aomori Prefecture, Hirosaki City, 5 Zaifucho
TEL	0172-33-5111
Email	tetsuyak@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Kushikata
Organization	Hirosaki University Graduate School of Medicine
Division name	Anesthesiology
Zip code	036-8562
Address	Aomori Prefecture, Hirosaki City, 5 Zaifucho
TEL	0172-33-5111
Homepage URL
Email	tetsuyak@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	self funding
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	Hirosaki University Graduate School of Medicine
Address	Aomori Prefecture, Hirosaki City, 5 Zaifucho
Tel	0172-33-5111
Email	tetsuyak@hirosaki-u.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

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 12 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	Preinitiation
Date of protocol fixation	2020 Year 07 Month 31 Day
Date of IRB	2020 Year 07 Month 31 Day
Anticipated trial start date	2020 Year 10 Month 12 Day
Last follow-up date	2025 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	2020 Year 10 Month 12 Day
Last modified on	2022 Year 04 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047945