UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036991 |
|---|---|
| Receipt number | R000042142 |
| 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 |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2020/06/07 14:50:36 |
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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
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
moma2@naver.com
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042142
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
