UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062869 |
|---|---|
| Receipt number | R000071968 |
| Scientific Title | Effects of Anesthetic Maintenance Agents on Hemodynamic Changes Following Pneumoperitoneum: A Retrospective Comparative Study of Remimazolam, Sevoflurane, Desflurane, and Propofol |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/10 11:12:42 |
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Basic information
Public title
Effects of Anesthetic Maintenance Agents on Hemodynamic Changes Following Pneumoperitoneum
Acronym
Effects of Anesthetic Maintenance Agents on Hemodynamic Changes Following Pneumoperitoneum
Scientific Title
Effects of Anesthetic Maintenance Agents on Hemodynamic Changes Following Pneumoperitoneum: A Retrospective Comparative Study of Remimazolam, Sevoflurane, Desflurane, and Propofol
Scientific Title:Acronym
Effects of Anesthetic Maintenance Agents on Hemodynamic Changes Following Pneumoperitoneum: A Retrospective Comparative Study of Remimazolam, Sevoflurane, Desflurane, and Propofol
Region
| Japan |
Condition
Condition
laparoscopic surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Obstetrics and Gynecology | Urology | Anesthesiology |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Since its introduction into clinical practice, remimazolam has become widely used as an anesthetic agent associated with minimal circulatory depression. However, intraoperative hypertension occurs more frequently with remimazolam than with propofol; a randomized controlled trial involving gynecological laparoscopic surgery demonstrated that mean arterial pressure was significantly higher in the remimazolam group after the patient was returned to a horizontal position. Differences in the anesthetic agents' effects on the autonomic nervous system are suggested to underlie these variations in circulatory response. Nevertheless, most existing studies compare remimazolam with propofol, with limited data comparing it to inhalational anesthetics. Furthermore, no studies have directly compared the temporal changes in hemodynamics triggered by the distinct physiological stress of pneumoperitoneum. In laparoscopic surgery, pneumoperitoneum serves as a complex stimulus, inducing hypertension through elevated intra-abdominal pressure (altering venous return and afterload), hypercapnia, and neuroendocrine responses (involving catecholamines, the renin-angiotensin system, and vasopressin), making it an ideal model for evaluating how anesthetic agents modulate these responses. This study aims to examine hemodynamic changes in response to pneumoperitoneum according to the anesthetic agent used for maintenance.
Basic objectives2
Others
Basic objectives -Others
To determine whether hemodynamic changes following pneumoperitoneum differ depending on the anesthetic maintenance agent used.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of the change from baseline in invasive mean arterial pressure during the 0-30 minute period after the start of pneumoperitoneum.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent laparoscopic surgery (or intra-abdominal surgery excluding thoracoscopic surgery) under general anesthesia at this facility between August 1, 2020, and March 31, 2026.
Key exclusion criteria
Patients with missing data
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Iwakiri |
Organization
The university of tokyo hospital.
Division name
Department of anesthesiology and pain relief center
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo. Japan.
TEL
03-3815-5411
iwakirim-ane@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Iwakiri |
Organization
The university of tokyo hospita.
Division name
Department of anesthesiology and pain relief center.
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo. Japan.
TEL
03-3815-5411
Homepage URL
https://www.ut-anes.org/2020/12/research/comprehensive_ethics/
iwakirim-ane@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The university of tokyo.
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
Graduate School of Medicine and Faculty of Medicine The University of Tokyo, Ethics Committee.
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo. Japan.
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Extract and analyze clinical information regarding the target patients from sources such as anesthesia records and electronic medical records.
Management information
Registered date
| 2026 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071968
