UMIN-CTR Clinical Trial

Public title

Clinical comparison of two anesthetic depth monitors; Noxious Stimulation Response Index(NSRI) versus BIS

Acronym

Clinical comparison of two anesthetic depth monitors

Scientific Title

Clinical comparison of two anesthetic depth monitors; Noxious Stimulation Response Index(NSRI) versus BIS

Scientific Title:Acronym

Clinical comparison of two anesthetic depth monitors

Region

Japan

Condition

Patients undergoing elective surgery under general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Today, there are several types of possible predictor of anesthetic depth in clinical setting. Bispectral index (BIS) is one of the most popular predictors. Noxious stimulation response index (NSRI) calculated by Smart Pilot View is one of the relatively new predictors. Smart Pilot View is new software, which records and monitors the administrated amount of anesthetics. Smart Pilot View calculates NSRI, which ranges from 0 to 100, using the end-tidal concentration of volatile anesthetics and the effect-site concentration of opioid, or the effect-site concentrations of propofol and opioid. NSRI is based on pharmacokinetics and pharmacodynamics of anesthetic agents, and is considered as a possible predictor of anesthetic depth; however, BIS which ranges from 0 to 100, is calculated by analyzing electroencephalogram. The relationship between NSRI and BIS has not been elucidated. In this study, we analyze the correlation between NSRI and BIS, and evaluate the usefulness of Smart Pilot View in clinical settings.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Correlation between NSRI and BIS

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients who are ASA 1 or 2 undergoing elective surgery under general anesthesia with tracheal intubation.
(150cm<=height<=200cm, 40kg<=body weight<=140kg)

Key exclusion criteria

Patients who are ASA 3 or more
Emergency surgery
General anesthesia with local anesthesia
Liver dysfunction
Renal dysfunction
Central nervous system disease

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Kenichiro Koda

Organization

Toho University Sakura medical center

Division name

Department of anesthesiology

Zip code

Address

564-1, Simoshizu, Sakura-shi, Chiba

TEL

043-462-8811

Email

kenich-kou@sakura.med.toho-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kenichiro Koda

Organization

Toho University Sakura medical center

Division name

Department of anesthesiology

Zip code

Address

564-1, Simoshizu, Sakura-shi, Chiba

TEL

043-462-8811

Homepage URL

Email

kenich-kou@sakura.med.toho-u.ac.jp

Institute

Toho University Sakura medical center
Department of anesthesiology

Institute

Department

Personal name

Organization

Toho University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

11

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015

Year

10

Month

09

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

05

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Patients are recruited if they undergo surgery with general anesthesia in our hospital from Oct 5 2015 and are matched with the criteria. We use sevoflurane, desflurane, or propofol as general anesthetics, and remifentanil and/or fentanyl as analgesics. Anesthetic regimen including choice of one of the three general anesthetics is depend on each anesthesiologist. This is observational study and does not involve any intervention. Twenty patients will be recruited in each group (sevoflurane, desflurane, propofol group) to compare NSRI with BIS.

Registered date

2015

Year

11

Month

04

Day

Last modified on

2017

Year

08

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022694