UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052040 |
|---|---|
| Receipt number | R000059373 |
| Scientific Title | Effect of General Anesthetics on Perioperative Serum Cytokine Level Changes: An Open-Label Randomized Comparative Trial |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/10/30 07:20:38 |
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Basic information
Public title
Impact of Anesthetic Drugs on Serum Cytokine Levels Before and After Surgery
Acronym
Impact of Anesthetic Drugs on Serum Cytokine Levels Before and After Surgery
Scientific Title
Effect of General Anesthetics on Perioperative Serum Cytokine Level Changes: An Open-Label Randomized Comparative Trial
Scientific Title:Acronym
Effect of General Anesthetics on Perioperative Serum Cytokine Level Changes: An Open-Label Randomized Comparative Trial
Region
| Japan |
Condition
Condition
Patients undergoing robot-assisted radical prostatectomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We comprehensively analyzed cytokines in blood collected from the arterial line before the incision and after the completion of surgery. Using unsupervised clustering methods such as principal component analysis and Ward's method, we examined the differences in cytokine changes induced by anesthetic drugs.
Basic objectives2
Others
Basic objectives -Others
The secondary outcome measure was all adverse events occurring until discharge.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in serum cytokine levels before and after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
During surgery, sevofluran will be assigned as the anesthetic agent.
Interventions/Control_2
During surgery, desflurane will be assigned as the anesthetic agent.
Interventions/Control_3
During surgery, propofol will be assigned as the anesthetic agent.
Interventions/Control_4
During surgery, remimazolam will be assigned as the anesthetic agent.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Adult males scheduled for robot-assisted radical prostatectomy at our institution with a systemic status classified as ASA class I or II. Candidates should be assessed and deemed appropriate by the attending anesthesiologist to undergo anesthesia management using a combination of general anesthesia with epidural and the insertion of an arterial line. Participants must have the ability to give informed consent. Furthermore, the attending anesthesiologist should be confident in administering safe anesthesia with any of the agents: sevoflurane, desflurane, propofol, or remimazolam.
Key exclusion criteria
Individuals with a history of allergies to anesthetic agents, those with a family history of malignant hyperthermia, patients using immunosuppressive agents preoperatively, individuals with a BMI less than 18.5 or greater than 30, those with a compromised systemic status (ASA class III or higher), patients with a preoperative hemoglobin level below 12.0 g/dL, and any other individuals deemed ineligible by the principal investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Matsuo |
| Middle name | |
| Last name | Mitsuhiro |
Organization
University of Toyama
Division name
Department of anesthesiology
Zip code
930-0194
Address
2630 Sugitani,Toyama, Toyama
TEL
0764347377
mmatsuo@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Matsuo |
| Middle name | |
| Last name | Mitsuhiro |
Organization
University of Toyama
Division name
Department of anesthesiology
Zip code
930-0194
Address
2630 Sugitani,Toyama, Toyama
TEL
0764347377
Homepage URL
mmatsuo@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama
Address
2630 Sugitani,Toyama, Toyama
Tel
0764347377
mmatsuo@med.u-toyama.ac.jp
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 | 09 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059373
