UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041953 |
|---|---|
| Receipt number | R000047876 |
| Scientific Title | Comparison of general anesthesia with new intravenous anesthetic remimazolam besilate versus propofol |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/10/10 09:59:19 |
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Basic information
Public title
Comparison of general anesthesia with new intravenous anesthetic remimazolam besilate versus propofol
Acronym
Comparison of general anesthesia with remimazolam besilate versus propofol
Scientific Title
Comparison of general anesthesia with new intravenous anesthetic remimazolam besilate versus propofol
Scientific Title:Acronym
Comparison of general anesthesia with new intravenous anesthetic remimazolam besilate versus propofol
Region
| Japan |
Condition
Condition
jaw deformity, jaw cyst, impacted tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
General anesthetics are classified into inhalation anesthetics and intravenous anesthetics. In Japan, also in Tsurumi university, general anesthetics mainly composed of intravenous anesthetics are widely used. Advantagesof intravenous andesthesia include less post operative nausea and vomiting, no air pollution caused by inhaled anesthetics in the operating room, and good quality of emergency. On the other hand, this propofol is clinically lacking in specific antagonists, has a long metabolic half-life, has strong circulatory inhibition, has vascular pain at the time of administration, is highly lipophilic, and is not water-soluble.
Remimazolam besilate (Anelem TM) used in this study is a novel ultra-short-acting benzodiazepine intravenous anesthetic with an imidazole benzodiazepine skeleton. Remimazolam besilate is water-soluble and does not contain fat in the solvent like propofol, so there is no lipid load due to long-term administration and the possibility of bacterial growth is low. It is also an advantage that it does not develop vascular pain and that it has a specific antagonist.In addition, it is said to exert a stable hypnotic action without suppressing hemodynamics.
Based on the above, in this study, we will compare and examine the general anesthesia using remimazolam besilate or propofol, focusing on the evaluation of the depth of anesthesia by vital signs and EEG.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to loss of consciousness, BIS value, blood pressure, heart rate, drug administration rate, existence of side effects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are 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 beslate is administered intravenously under general anesthesia.The basic dose is 12 mg/kg/h for introducing anesthesia and 1 mg/kg/h for maintaining anesthesia, and the dose is appropriately reduced according to age and physique.
Interventions/Control_2
Propofol is administered intravenously under general anesthesia.The basic dose is 4.0 mcg/ml for introducing anesthesia and 3.5 mcg/ml for maintaining anesthesia, and the dose is appropriately reduced according to age and physique.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
American Society of Anesthesiologists Physical Status Classification System
ASAPS1,2
Key exclusion criteria
Patients with ASAPS3 or above, under 20 years old, over 80 years old, patients taking psychiatric stabilizers, mental illness, cerebrovascular accidents, bronchial asthma (due to drug use contraindications), neuromuscular disease patients and patients with acute obstructive angle glaucoma (Contraindications for Remimazolam besilate)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Fujii-Abe |
Organization
Tsurumi University, School of Dental Medicine
Division name
Department of Dental Anesthesiology
Zip code
230-8501
Address
2-1-3, Tsurumi-ku, Tsurumi, Yokohama city, Japan
TEL
045-580-8343
fujii-keiko@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Fujii-Abe |
Organization
Tsurumi University, School of Dental Medicine
Division name
Department of Dental Anesthesiology
Zip code
230-8501
Address
2-1-3, Tsurumi-ku, Tsurumi, Yokohama city, Japan
TEL
045-580-8343
Homepage URL
fujii-keiko@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Tsurumi University
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
Tsurumi University, School of Dental Medicine
Address
2-1-3, Tsurumi-ku, Tsurumi, Yokohama city, Japan
Tel
045-580-8343
fujii-keiko@tsurumi-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
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results had already been submitted and accepted in Anesthesia Progress.
Management information
Registered date
| 2020 | Year | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047876
