UMIN-CTR Clinical Trial

Basic information
Public title	The effect of SPI (surgical pleth index)-guided analgesia on postoperative immune system in the elderly patients
Acronym	SPI-IEP
Scientific Title	The effect of SPI (surgical pleth index)-guided analgesia on the peri-operative stress hormone secretion and postoperative immune system in the elderly patients
Scientific Title:Acronym	SPI-SHI
Region	Asia(except Japan)

Condition
Condition	randomized controlled trial
Classification by specialty	Clinical immunology Geriatrics Surgery in general Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the difference between the method of empirical administration based on the increase in pulse and blood pressure and the method of administration using the Surgical Pleth Index (SPI) during the operation of the elderly patient.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the difference of intravenous IV remifentanil dose
Key secondary outcomes	peri operative cortisol, epinephrine, norepinephrine, ACTH,IL6, TNF a, NK cell activity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Intavenous remifentanil wiill be titrated until surgical pleth index (SPI) value is within 20-50 in SPI group. Time intervalof administration is minimum 5min
Interventions/Control_2	Intavenous remifentanil will be titrated when blood pressure or heart rate is increased to above 20% of the baseline value in control group for 1 min. Time intervalof administration is minimum 5min .
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	65 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult patients aged more than 65 years with a physical status of 1-3(the American Society of Anesthesiologists rating) who are scheduled to undergo GI cancer surgery
Key exclusion criteria	Patients with a history of hypersensitivity to drugs, and those receiving analgesics, sedatives or psychiatric medication will be excluded.
Target sample size	86

Research contact person
Name of lead principal investigator	1st name Young ju Middle name Last name Won
Organization	Guro Hospital, Korea University College of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code	03803
Address	148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL	82-2-2626-1437
Email	moma2@naver.com

Public contact
Name of contact person	1st name Young Ju Middle name Last name Won
Organization	Guro Hospital, Korea University College of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code	08308
Address	148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL	82-2-2626-2-1437
Homepage URL
Email	moma2@naver.com

Sponsor
Institute	Korea University
Institute
Department

Funding Source
Organization	Korea University national research foundation of korea
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Guro Hospital, Korea University College of Medicine
Address	gurodong ro 148
Tel	02-2626-1964
Email	kughirb@naver.com

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	2023 Year 01 Month 01 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	Open public recruiting
Date of protocol fixation	2019 Year 05 Month 27 Day
Date of IRB	2019 Year 05 Month 27 Day
Anticipated trial start date	2019 Year 05 Month 27 Day
Last follow-up date	2023 Year 01 Month 01 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 06 Month 07 Day
Last modified on	2020 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042142