UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical comparison of two anesthetic depth monitors; Noxious Stimulation Response Index(NSRI) versus BIS
Title of the study (Brief title)	Clinical comparison of two anesthetic depth monitors
Region	Japan

Condition
Condition	Patients undergoing elective surgery under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Correlation between NSRI and BIS
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Kenichiro Koda
Organization	Toho University Sakura medical center
Division name	Department of anesthesiology
Address	564-1, Simoshizu, Sakura-shi, Chiba
TEL	043-462-8811
Email	kenich-kou@sakura.med.toho-u.ac.jp

Public contact
Name of contact person	Kenichiro Koda
Organization	Toho University Sakura medical center
Division name	Department of anesthesiology
Address	564-1, Simoshizu, Sakura-shi, Chiba
TEL	043-462-8811
Homepage URL
Email	kenich-kou@sakura.med.toho-u.ac.jp

Sponsor
Institute	Toho University Sakura medical center Department of anesthesiology
Institute
Department

Funding Source
Organization	Toho University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 11 Month 04 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 10 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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.

Management information
Registered date	2015 Year 11 Month 04 Day
Last modified on	2017 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022694