UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048574
Receipt No. 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 2022/08/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email koshikakyotarou@tdc.ac.jp

Sponsor
Institute Tokyo dental college
Institute
Department

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
Email 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 Preinitiation
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
2022 Year 08 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055350

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.