UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045824 |
|---|---|
| Receipt number | R000052311 |
| Scientific Title | Effect of remimazolam and propofol anesthesia on autonomic nerve activities during Le Fort 1 osteotomy under general anesthesia. |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2024/03/31 11:31:48 |
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Basic information
Public title
Effect of remimazolam and propofol anesthesia on autonomic nerve activities during Le Fort 1 osteotomy under general anesthesia.
Acronym
Effect of remimazolam and propofol anesthesia on autonomic nerve activities.
Scientific Title
Effect of remimazolam and propofol anesthesia on autonomic nerve activities during Le Fort 1 osteotomy under general anesthesia.
Scientific Title:Acronym
Effect of remimazolam and propofol anesthesia on autonomic nerve activities.
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using frequency analysis of heart rate variability and blood pressure variability to compare changes in autonomic nerve activity induced by surgical stimulation with remimazolam and propofol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in heart rate variability and blood pressure variability before and after surgical stimulation with propofol and remimazolam.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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 started at 12 mg/kg/h by continuous intravenous infusion until the loss of consciousness, followed by 1 mg/kg/h to be adjusted as appropriate until the end of surgery.
Interventions/Control_2
Propofol started at 4.0mcg/ml continuous intravenous infusion until the loss of consciousness, followed by adjusted as appropriate until the end of surgery.
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 surgery under general anesthesia and an American Society of Anesthesiologists physical status of 1.
Key exclusion criteria
ASA-PS II or higher, emergency surgery, inability to obtain consent from the patient, taking benzodiazepines, contraindications to the administration of drugs used in this study, and those under 18 years of age.
Target sample size
50
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
| 2021 | Year | 10 | Month | 21 | 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
50
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 | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 22 | 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
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052311
