UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029983
Receipt number R000034242
Scientific Title Relibility of BIS (BIS monitor) and PSI (SEDLine system) during desflurane anesthesia
Date of disclosure of the study information 2017/11/20
Last modified on 2020/11/17 10:16:47

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Basic information

Public title

Relibility of BIS (BIS monitor) and PSI (SEDLine system) during desflurane anesthesia

Acronym

BIS and PSI

Scientific Title

Relibility of BIS (BIS monitor) and PSI (SEDLine system) during desflurane anesthesia

Scientific Title:Acronym

BIS and PSI

Region

Japan


Condition

Condition

Patients under general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

BIS in BIS monitor and PSI in SEDLine system are widely used for the evaluation of depth of general anesthesia. Unfortunately, both analytic software using either BIS monitor or SEDLine system is based on the data of propofol anesthesia and sevoflurane anesthesia and the data of desflurane anesthesia is not used. Validity of analytic software using either BIS monitor or SEDLine system has not been checked. In this study, we tested the relationship between desflurane concentration and BIS or PSI, and checked reliability of BIS and PSI during desflurane anesthesia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

relationship between desflurane concentration and BIS (BIS monitor) or PSI (SEDLine system)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Stepwise increase in inhalation concentration of desflurane, 3%,4%,and 5%.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patient under desflurane anesthesia

Key exclusion criteria

20 years old<
80 years old>
emergency operation patient

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Tatsuo
Middle name
Last name Yamamoto

Organization

Kumamoto University Hospital

Division name

Anesthesiology

Zip code

860-8556

Address

1-1-1 Honjyo, Chuo-ku, Kumamoto-shi

TEL

096-373-5275

Email

yamyam@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name Yamamoto
Middle name
Last name Tatsuo

Organization

Kumamoto University Hospital

Division name

Anesthesiology

Zip code

860-8556

Address

1-1-1 Honjyo, Chuo-ku, Kumamoto-shi

TEL

096-373-5275

Homepage URL


Email

yamyam@kumamoto-u.ac.jp


Sponsor or person

Institute

Kumamoto University Hospital
Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

none

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

Kumamoto University Hospital, Ethical Committee

Address

1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto

Tel

0963735275

Email

yamyam@kumamoto-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

2017 Year 11 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


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

2017 Year 11 Month 13 Day

Date of IRB

2017 Year 11 Month 15 Day

Anticipated trial start date

2017 Year 11 Month 20 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 06 Month 30 Day

Date trial data considered complete

2018 Year 08 Month 31 Day

Date analysis concluded

2018 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 15 Day

Last modified on

2020 Year 11 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034242


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name