UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046531 |
|---|---|
| Receipt number | R000053087 |
| Scientific Title | Effects of Anesthetics on Perioperative Oxygen Supply and Demand Balance: A Comparison of Propofol and Remimazolam |
| Date of disclosure of the study information | 2022/01/05 |
| Last modified on | 2024/05/26 11:07:57 |
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Basic information
Public title
Effects of Anesthetics on Perioperative Oxygen Supply and Demand Balance: A Comparison of Propofol and Remimazolam
Acronym
Effects of Anesthetics on Perioperative Oxygen Supply and Demand Balance: A Comparison of Propofol and Remimazolam
Scientific Title
Effects of Anesthetics on Perioperative Oxygen Supply and Demand Balance: A Comparison of Propofol and Remimazolam
Scientific Title:Acronym
Effects of Anesthetics on Perioperative Oxygen Supply and Demand Balance: A Comparison of Propofol and Remimazolam
Region
| Japan |
Condition
Condition
Laparotomy under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to measure changes in the oxygen supply-demand balance during the perioperative period for each general anesthetic using an arthrocentesis calorimeter.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change of oxygen consumption and carbon dioxide production in the perioperative period
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
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Remimazolam group
Interventions/Control_2
Propofol group
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Surgical cases undergoing general anesthesia in our operating room are eligible. Eligible surgical procedures are laparotomies with a scheduled duration of at least 2 hours and no more than 6 hours.
Key exclusion criteria
Allergy to remimazolam or propofol, history of central disease, history of neurobacterial disease, uncontrolled cardiac or respiratory failure, renal or hepatic insufficiency, inability to consent to research, procedures requiring isolated lung ventilation, emergency surgery.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kaneyuki |
| Middle name | |
| Last name | kawamae |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236331122
yarimizu.kenya@gmail.com
Public contact
Name of contact person
| 1st name | kenya |
| Middle name | |
| Last name | yarimizu |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236331122
Homepage URL
yarimizu.kenya@gmail.com
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Yamagata University Medical School Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University Faculty of Medicine Ethics Committee
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
Tel
0236331122
yarimizu.kenya@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
| 2022 | Year | 01 | Month | 05 | 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
| 2021 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 04 | 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
| 2022 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053087
