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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048351
Receipt No. R000055068
Scientific Title Effect of surgical pleth index-guided remifentanil administration on perioperative outcomes in elderly patients: a prospective randomized controlled trial
Date of disclosure of the study information 2022/07/12
Last modified on 2022/07/12

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Basic information
Public title Effect of surgical pleth index-guided remifentanil administration on perioperative outcomes in elderly patients: a prospective randomized controlled trial
Acronym SPI-guided analgesia in elderly patients
Scientific Title Effect of surgical pleth index-guided remifentanil administration on perioperative outcomes in elderly patients: a prospective randomized controlled trial
Scientific Title:Acronym SPI-guided analgesia in elderly patients
Region
Asia(except Japan)

Condition
Condition Patients aged 65 to 90 years undergoing laparoscopic colorectal cancer surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to investigate whether there is a change in perioperative outcomes following the administration of opioids intraoperatively according to the surgical pleth index (SPI) value versus hemodynamic parameters (heart rate or blood pressure) in elderly patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes intraoperative opioid (remifentanil) consumption
Key secondary outcomes intraoperative hemodynamic instability events, awakening time, pain score, fentanyl consumption and incidence of delirium in the post-anesthesia care unit (PACU), and perioperative changes in immunologic markers, including interleukin-6 and natural killer (NK) cell activity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 receive remifentanil infusion guided by SPI (group S) during surgery
Interventions/Control_2 receive remifentanil infusion guided by clinical judgement based on hemodynamic parameters (group C) during surgery
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
60 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were scheduled to undergo elective laparoscopic colorectal cancer surgery, aged 65 to 90 years, with an American Society of Anesthesiologists (ASA) physical status I to III
Key exclusion criteria history of neuromuscular, neurological, or psychological diseases (dementia, Parkinsons disease, seizure disorders, head injury), abuse of alcohol or illicit drugs or chronic use of psychoactive medication; significant cardiac arrhythmia (atrial fibrillation, or atrioventricular block exceeding 1st degree), and hemodynamically unstable condition before surgery
Target sample size 74

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

Public contact
Name of contact person
1st name Seok Kyeong
Middle name
Last name Oh
Organization Korea University Guro Hospital
Division name Department of Anesthesiology and Pain Medicine
Zip code 08308
Address Gurodong-ro 148, Guro-gu, Seoul, Republic of Korea
TEL 82-2-2626-1437
Homepage URL
Email nanprayboy@korea.ac.kr

Sponsor
Institute Korea University Guro Hospital
Institute
Department

Funding Source
Organization National Research Foundation of Korea (NRF) grant funded by the Korea government (No. NARS3270Q)
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 Korea University Guro Hospital Institutional Review Board, Seoul, Republic of Korea
Address Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul 08308, Republic of Korea
Tel 82-2-2626-1632
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
2022 Year 07 Month 12 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 75
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 No longer recruiting
Date of protocol fixation
2019 Year 05 Month 22 Day
Date of IRB
2019 Year 05 Month 22 Day
Anticipated trial start date
2019 Year 05 Month 27 Day
Last follow-up date
2022 Year 03 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 07 Month 12 Day

Other
Other related information

Management information
Registered date
2022 Year 07 Month 12 Day
Last modified on
2022 Year 07 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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