UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048574 |
|---|---|
| Receipt number | R000055350 |
| Scientific Title | A Comparative Study of the Enhancement of the Muscle Relaxant Effect of Local Anesthetics Used During General Anesthesia Using Remimazolam or Propofol |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2023/04/05 17:20:28 |
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Basic information
Public title
Effect of remimazolam or propofol on the muscle relaxant effect of local anesthetics during general anesthesia
Acronym
Effect of remimazolam or propofol on the muscle relaxant effect of local anesthetics during general anesthesia
Scientific Title
A Comparative Study of the Enhancement of the Muscle Relaxant Effect of Local Anesthetics Used During General Anesthesia Using Remimazolam or Propofol
Scientific Title:Acronym
A Comparative Study of the Enhancement of the Muscle Relaxant Effect of Local Anesthetics Used During General Anesthesia Using Remimazolam or Propofol
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
General anesthesia is performed using remimazolam or propofol, and muscle relaxation after administration of local anesthetics is compared and examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using a muscle relaxation monitor, the TOF ratio is recorded every minute for 20 minutes after the administration of local anesthesia and compared.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
In the remimazolam group, the drug is administered intravenously continuously at 12 mg/kg/h according to the package insert, and after the patient becomes unconscious, it is infused continuously at a rate of 1 mg/kg/h and the rate is adjusted accordingly to maintain adequate depth of anesthesia.
Interventions/Control_2
In the propofol group, start with TCI 4.0mcg/ml and adjust the administration rate accordingly to maintain adequate anesthetic depth after the patient has lost consciousness.
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
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18-45 years scheduled for orthognathic jaw surgery under general anesthesia, ASA-PS I
Key exclusion criteria
ASA-PS II or higher, emergency surgery, patient or parental consent not obtained, taking benzodiazepines, contraindicated for administration of medications used in this study, or under 18 years of age
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | kyotarou |
| Middle name | |
| Last name | koshika |
Organization
Tokyo dental college
Division name
Department of Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Kanda Misaki, Chiyoda, Tokyo
TEL
03-6380-9113
koshikakyotarou@tdc.ac.jp
Public contact
Name of contact person
| 1st name | kyotarou |
| Middle name | |
| Last name | koshika |
Organization
Tokyo dental college
Division name
Department of Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Kanda Misaki, Chiyoda, Tokyo
TEL
03-6380-9113
Homepage URL
koshikakyotarou@tdc.ac.jp
Sponsor or person
Institute
Tokyo dental college
Institute
Department
Personal name
Funding Source
Organization
Tokyo dental college
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
Tokyo dental college
Address
2-9-18 Kanda Misaki, Chiyoda, Tokyo
Tel
03-6380-9113
koshikakyotarou@tdc.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
| 2022 | Year | 08 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2024 | 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 | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055350
