UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038214
Receipt number R000043328
Scientific Title Effect of anesthetic agents on nociceptive evoked potentials
Date of disclosure of the study information 2019/10/20
Last modified on 2022/09/08 11:59:37

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Shinshu University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043328


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name