UMIN-CTR Clinical Trial

Basic information
Public title	Effect of anesthetic agents on nociceptive evoked potentials
Acronym	Effect of anesthetic agents on nociceptive evoked potentials
Scientific Title	Effect of anesthetic agents on nociceptive evoked potentials
Scientific Title:Acronym	Effect of anesthetic agents on nociceptive evoked potentials
Region	Japan

Condition
Condition	patients who get general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the effect of anesthetic agents on nociceptive evoked potentials using intra-epidermal stimulation
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amplitude of nociceptive evoked potentials
Key secondary outcomes	Latency of nociceptive evoked potentials Numerical Rating Scale of pain Bispectral Index

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	5
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	intravenous administration of remifentanil effect-site concentration: 1.0-3.0 nanogram/ml, 5 minutes
Interventions/Control_2	intravenous administration of propofol effect-site concentration: 0.5-1.0 microgram/ml, 5 minutes
Interventions/Control_3	inhalation of sevoflurane 0.2-0.5 age-related minimum alveolar concentration, 5 minutes
Interventions/Control_4	intravenous administration of propofol effect-site concentration: 0.5-1.0 microgram/ml, 5 minutes, 2 times
Interventions/Control_5	inhalation of sevoflurane 0.2-0.5 age-related minimum alveolar concentration, 5 minutes, 2 times
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	patients over 20 years old who get surgery under general anesthesia in our hospital
Key exclusion criteria	1) ASA-PS over 3 2) surgery for malignancy or electrode site 3) diabetes mellitus, dementia or epilepsy 4) inpanted pacemaker, implantable cardioverter-defibrillator or deep brain stimulator 5) skin disorder or paresthesia on electrode site 6) patients without consent
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Ishida
Organization	Shinshu University School of Medicine
Division name	The Department of Anesthesiology and Resuscitology
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2670
Email	tisd@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Ishida
Organization	Shinshu University School of Medicine
Division name	The Department of Anesthesiology and Resuscitology
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto, Nagano
TEL	0263-37-2670
Homepage URL
Email	tisd@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Shinshu 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	Shinshu University School of Medicine Research Ethics Committee
Address	3-1-1 Asahi, Matsumoto, Nagano
Tel	0263-37-2572
Email	mdrinri@shinshu-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	2019 Year 10 Month 20 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	55
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	2019 Year 07 Month 27 Day
Date of IRB	2019 Year 09 Month 02 Day
Anticipated trial start date	2019 Year 10 Month 01 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	2019 Year 10 Month 06 Day
Last modified on	2022 Year 09 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043328