UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048351 |
|---|---|
| Receipt number | 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 | 2023/07/17 13:13:28 |
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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
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
nanprayboy@korea.ac.kr
Sponsor or person
Institute
Korea University Guro Hospital
Institute
Department
Personal name
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
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
https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-02011-5
Publication of results
Published
Result
URL related to results and publications
https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-02011-5
Number of participants that the trial has enrolled
75
Results
The primary endpoint was intraoperative remifentanil consumption. Secondary endpoints were intraoperative hemodynamic instability, pain score, fentanyl consumption and delirium in the post-anesthesia care unit (PACU), and perioperative changes in interleukin-6 and natural killer (NK) cell activity.
Results date posted
| 2023 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Seventy-five patients (38 in the SPI group and 37 in the conventional group) completed this study. There was no significant difference in patient characteristics, baseline clinical data, anesthesia time, and the types of operation between the two groups.
Participant flow
Patients aged 65 to 90 years who underwent laparoscopic colorectal cancer surgery under sevoflurane and remifentanil anesthesia were randomized to receive remifentanil guided by SPI or conventional clinical judgment based on hemodynamic parameters. The primary endpoint was intraoperative remifentanil consumption. Secondary endpoints were intraoperative hemodynamic instability, pain score, fentanyl consumption and delirium in the post-anesthesia care unit , and perioperative changes in interleukin-6 and natural killer cell activity.
Adverse events
No serious adverse event.
Outcome measures
Delirium was defined as positive in the PACU using the CAM-ICU (confusion assessment method for the intensive care unit) tool, and it was assessed before transferring from PACU to the ward.
NK cell activity and IL-6 measurement
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055068
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