UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043925 |
|---|---|
| Receipt number | R000042200 |
| Scientific Title | Safety Assessment of Ultra-low-flow and Low-flow Sevoflurane Anesthesia Using Carbon Dioxide Absorbent YABASHI LIME-f |
| Date of disclosure of the study information | 2021/04/14 |
| Last modified on | 2025/06/03 13:39:29 |
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Basic information
Public title
Safety Assessment of Ultra-low-flow and Low-flow Sevoflurane Anesthesia Using Carbon Dioxide Absorbent YABASHI LIME-f
Acronym
SAULSAY
Scientific Title
Safety Assessment of Ultra-low-flow and Low-flow Sevoflurane Anesthesia Using Carbon Dioxide Absorbent YABASHI LIME-f
Scientific Title:Acronym
SAULSAY
Region
| Japan |
Condition
Condition
Colon cancer, Benign colorectal disease
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we use Yabashilime-f and perform respiratory control under sevoflurane anesthesia with a fresh gas flow rate of 0.5 L / min (very low flow rate), 1 L / min (low flow rate), or 2 L / min of normal flow rate. In colorectal disease surgery, we will evaluate the concentration of Compound A in the anesthesia circuit over time and the presence or absence of postoperative acute kidney injury onset in patients. This will examine whether sevoflurane very low flow anesthesia and low flow anesthesia surgery can be performed without causing renal dysfunction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of Compound A concentration in anesthesia circuit over time
Key secondary outcomes
Whether the patient has postoperative acute kidney disease
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
fresh gas frow rate 0.5 L/h
Interventions/Control_2
fresh gas frow rate 1 L/h
Interventions/Control_3
fresh gas frow rate 2 L/h
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Scheduled colon cancer resection ( over 6 hours anesthesia )
Key exclusion criteria
Renal function is normal (eGFR 90 or more) and liver function is normal (total bilirubin is 1.5 times or less of the upper limit of the medical institution's standard value and AST and ALT are 2.5 times or less of the upper limit of the medical institution's standard value)
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Kimitoshi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Nagoya university graduate school of medicine
Division name
Department of anesthesiology
Zip code
466-8550
Address
65 tsurumai showa nagoya
TEL
052-744-2340
nishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Ando |
Organization
Nagoya university hospital
Division name
Department of surgery section
Zip code
466-8550
Address
65 tsurumai showa nagoya
TEL
052-744-2340
Homepage URL
bakagarasu7@gmail.com
Sponsor or person
Institute
Nagoya university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya university graduate school of medicine
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
Nagoya university graduate school of medicine
Address
65 tsurumai showa nagoya
Tel
052-744-2973
ethics@med.nagoya-u.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
| 2021 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
45
Results
In a total of 18 patients, the median anesthesia times were 497.0, 549.0, and 696.5 minutes for the 2.0 L/min, 1.0 L/min, and 0.5 L/min FGF groups, respectively. Compound A was not observed at all gas sampling points and was significantly lower than the threshold mean of 20 ppm. With regard to AKI onset, a total of two patients had creatinine content 1.5 times the reference value at POD 1 and were diagnosed as Stage 1 according to KDIGO guidelines.
Results date posted
| 2025 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients were recruited between November 2019 and June 2022. Inclusion criteria were as follows: patients with American Society of Anesthesiologists physical status 1 or 2, aged >20 years, and scheduled for elective colorectal resection. Patients with renal dysfunction (estimated glomerular filtration rate <90) or hepatic dysfunction (total bilirubin >1.5 times and <3.0 times the institutional upper limit, and/or aspartate aminotransferase or alanine aminotransferase >2.5 times the upper limit) were excluded. Additional exclusions included patients with preoperative risk factors for perioperative AKI, such as hypertension, diabetes mellitus, congestive heart failure, impaired cardiac function, use of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, non-steroidal anti-inflammatory drugs (NSAIDs), antibacterial agents, or diuretics. Pregnant women were also excluded. Patients were randomly assigned to one of three groups based on FGF: 2.0, 1.0, or 0.5 L/min, using computer-generated randomization.
Participant flow
Enrollment: Assessed for eligibility (n=45)
Exclusion: Surgery canceled n=3, Exclusion criteria n=12
Randomization: Randomized (n=30)
Allocation: 0.5 L/min (n=9) 1.0 L/min (n=10) 2.0 L/min (n=11)
Withdraw(Not enough time for surgery): 0.5 L/min (n=3) 1.0 L/min (n=4) 2.0 L/min (n=5)
Complete study and analyses: 0.5 L/min (n=6) 1.0 L/min (n=6) 2.0 L/min (n=6)
Adverse events
Nothing of note
Outcome measures
Measurement of Compound A concentration in anesthesia circuit over time
Whether the patient has postoperative acute kidney disease
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042200
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/04/22 | 臨床研究_計画書（麻酔科・安藤貴宏）0207.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/04/22 | 症例データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/04/22 | ANDO_T_Supplemental table_20241115.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/42200
