UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051489 |
|---|---|
| Receipt number | R000057714 |
| Scientific Title | The influence of gender on emergence from general anesthesia with remimazolam - a cofort study in dental and oral surgery patients. |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2023/06/30 14:09:17 |
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Basic information
Public title
Investigation of differences in the anesthetic action of the intravenous anesthetic remimazolam according to gender.
Acronym
Differences in anesthetic action of remimazolam by gender
Scientific Title
The influence of gender on emergence from general anesthesia with remimazolam - a cofort study in dental and oral surgery patients.
Scientific Title:Acronym
Examining differences in emergence from remimazolam anesthesia by gender
Region
| Japan |
Condition
Condition
Dental or oral surgical disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate gender differences in the anesthetic action of remimazolam.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time from discontinuation of remimazolam to tracheal extubation
Key secondary outcomes
1. Patient Characteristics (age, weight, height, BMI, sex, medical history, medicine, clinical examination)
2. Surgical information (procedure, operation time, anesthesia time)
3. Blood concentration of remimazolam and its metabolite CNS7054 at discontinuation of remimazolam and tracheal extubation or administration of flumazenil
4. BIS values at discontinuation of remimazolam and tracheal extubation or administration of flumazenil
5. Remimazolaml amount and average infusion rate of remimazolam
6. Remifentanil amount and average infusion rate of remifentanil
7. BIS values at pre-anesthesia, loss of consciousness, and during anesthesia
8. Time from start of remimazolam to loss of consciousness
9. Number of bolus dose of remimazolam
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing general anesthesia at the Department of Dental Anesthesiology, Okayama University Hospital between the date of approval by the director of the research institution and December 31, 2025
2. Patients who are able to obtain written consent with their own free to participate in research.
3. Patients scheduled for total intravenous anesthesia using remimazolam and remifentanil.
4. Patients who are between 18 and 50 years of age at the time of consent
5. Patients with a body mass index (BMI) of less than 30
6. Patients whose American Society of Anesthesiologists physical status (ASA-PS) is 1
7. Patients scheduled for anesthesia less than 4 hours
8. Patients undergoing dental treatment or minor oral surgery.
9. No need receiving opioid analgesics for postoperative analgesia
Key exclusion criteria
1. Patients with contraindications to remimazolam, remifentanil, or rocuronium
2. Patients who require preanesthetic medication
3. Patients who are deemed inappropriate for participation in the study by the principal investigator or study investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Okayama University Hospital
Division name
Department of Dental Anesthesiology
Zip code
700-8525
Address
2-5-1 Shikata-cho Kita-ku Okayama
TEL
086-235-6721
higuti@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Okayama University Hospital
Division name
Department of Dental Anesthesiology
Zip code
700-8525
Address
2-5-1 Shikata-cho Kita-ku Okayama
TEL
086-235-6721
Homepage URL
higuti@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital
Address
2-5-1 Shikata-cho Kita-ku Okayama
Tel
086-235-6938
mae6605@adm.okayama-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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compare emergence time from total intravenous anesthesia with remimazolam between men and women.
Management information
Registered date
| 2023 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057714
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
