UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045612 |
|---|---|
| Receipt number | R000052054 |
| Scientific Title | The effect of anesthetics on the circulatory dynamics during induction of general anesthesia Comparison of propofol and remimazolam besilate |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/01/12 21:47:46 |
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Basic information
Public title
The effect of anesthetics on the circulatory dynamics during induction of general anesthesia Comparison of propofol and remimazolam besilate
Acronym
The effect of anesthetics on the circulatory dynamics during induction of general anesthesia
Scientific Title
The effect of anesthetics on the circulatory dynamics during induction of general anesthesia Comparison of propofol and remimazolam besilate
Scientific Title:Acronym
The effect of anesthetics on the circulatory dynamics during induction of general anesthesia
Region
| Japan |
Condition
Condition
Patients undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether propofol and remimazolam besilate have different effects on circulatory dynamics (blood pressure, heart rate, and cardiac output) before and after induction of general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure before and after induction of anesthesia
Key secondary outcomes
Electrocardiogram, heart rate, cardiac output, BIS, transcutaneous oxygen saturation, and regional cerebral oxygen saturation before and after induction of anesthesia.
Time after induction of anesthesia until loss of consciousness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
After entering the operating room, induction and maintenance of anesthesia are performed using propofol.
Propofol should be administered according to the package insert.
Interventions/Control_2
After entering the operating room, induction and maintenance of anesthesia are performed using remimazolam besilate.
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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients between 45 and 80 years old with ASA (American Society of Anesthesia) PS (Physical Status) 1-2 scheduled for general anesthesia at Tokushima University Hospital.
Key exclusion criteria
ASA PS3 or higher cases
Cases in which consent was not obtained
Emergency surgery cases
Patients with cardiac disease
Pregnant and lactating women
Severe (Child-pugh classification C) liver dysfunction
Cases under dialysis
Patients with organic brain damage or epilepsy
Patients with a history of drug dependence
Patients with severe lipid metabolism disorders
Obese cases with a BMI of 30 or higher
Cases in which securing the airway is difficult
Cases with intestinal obstruction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Kinoshita |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima 770-8503, Japan
TEL
088-633-7181
michiko-kinoshita@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Sekiguchi |
Organization
Tokushima University Hospital
Division name
Department of Anesthesiology
Zip code
770-8503
Address
2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima 770-8503, Japan
TEL
088-633-7181
Homepage URL
sekiguchi.riyou@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital, Anesthesiology
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
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima-shi, Tokushima 770-8503, Japan
Tel
088-633-7181
sekiguchi.riyou@tokushima-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 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052054
