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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046531
Receipt No. 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 2022/01/04

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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 Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

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
65 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
Email 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
Email yarimizu.kenya@gmail.com

Sponsor
Institute Yamagata University
Institute
Department

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
Email 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 Preinitiation
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
2022 Year 01 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053087

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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