UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056842 |
|---|---|
| Receipt number | R000064464 |
| Scientific Title | Comparison of the Greenhouse Effects of Gases Used in Operating Rooms: Anesthetic Desflurane vs. Surgical Insufflation Carbon Dioxide |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/07/29 16:33:46 |
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Basic information
Public title
Comparison of the Greenhouse Effects of Gases Used in Operating Rooms: Anesthetic Desflurane vs. Surgical Insufflation Carbon Dioxide
Acronym
Comparison of the Greenhouse Effects of Gases Used in Operating Rooms: Anesthetic Desflurane vs. Surgical Insufflation Carbon Dioxide
Scientific Title
Comparison of the Greenhouse Effects of Gases Used in Operating Rooms: Anesthetic Desflurane vs. Surgical Insufflation Carbon Dioxide
Scientific Title:Acronym
Comparison of the Greenhouse Effects of Gases Used in Operating Rooms: Anesthetic Desflurane vs. Surgical Insufflation Carbon Dioxide
Region
| Japan |
Condition
Condition
Cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to measure the amount of desflurane and insufflation carbon dioxide used in the operating room and to examine their impact as greenhouse gases. By doing so, we aim to evaluate which gases should be reduced to prevent global warming in the operating room setting. The target disease for this study is cholecystitis requiring laparoscopic cholecystectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of desflurane used and the amount of carbon dioxide used for insufflation during laparoscopic cholecystectomy for cholecystitis
Key secondary outcomes
Surgical time
Anesthesia time
Insufflation time
Blood loss
Fluid balance (Input and Output)
Ventilation settings
Fresh gas flow rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older at the time of informed consent, with an ASA class 1 or 2 status.
Patients scheduled for laparoscopic cholecystectomy.
Patients who have provided written informed consent from themselves or their legal representative.
Patients scheduled to receive general anesthesia alone or general anesthesia combined with epidural anesthesia.
Key exclusion criteria
Patients deemed unsuitable for anesthesia management with inhalational anesthetics.
Other patients whom the attending physician deems inappropriate for participation in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kondo |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Anesthesiology
Zip code
7390041
Address
513, Jike, Saijo-cho, Higashihiroshima-shi, Hiroshima, Japan
TEL
082-423-2176
h.kondo1986@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kondo |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Anesthesiology
Zip code
7390041
Address
513, Jike, Saijo-cho, Higashihiroshima-shi, Hiroshima, Japan
TEL
082-423-2176
Homepage URL
h.kondo1986@gmail.com
Sponsor or person
Institute
National Hospital Organization Higashihiroshima Medical Center
Institute
Department
Personal name
Funding Source
Organization
No funding organization
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
National Hospital Organization Higashihiroshima Medical Center
Address
513, Jike, Saijo-cho, Higashihiroshima-shi, Hiroshima, Japan
Tel
082-423-2176
h.kondo1986@gmail.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
| 2025 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ethical Review Information
Approval Status: Approved
Approval Number: 2074-73
Approval Date: January 10, 2025
Approving Institution: Higashihiroshima Medical Center
Conflict of Interest (COI) Information
Conflict of Interest: None
Comments: There are no conflicts of interest among the investigators or related parties.
Management information
Registered date
| 2025 | Year | 01 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064464
