UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054590 |
|---|---|
| Receipt number | R000062244 |
| Scientific Title | Exploration of Factors Influencing the Pharmacokinetics of Remimazolam - A Cofort Study in Dental and Oral Surgery Patients. |
| Date of disclosure of the study information | 2024/06/10 |
| Last modified on | 2024/09/03 10:11:57 |
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Basic information
Public title
Investigation of factors affecting the in vivo degradation of the intravenous anesthetic remimazolam.
Acronym
Factors affecting the in vivo degradation of remimazolam
Scientific Title
Exploration of Factors Influencing the Pharmacokinetics of Remimazolam - A Cofort Study in Dental and Oral Surgery Patients.
Scientific Title:Acronym
Exploring Factors Affecting Remimazolam Pharmacokinetics
Region
| Japan |
Condition
Condition
Dental and Oral Surgical Diseases
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients undergoing dental treatment or oral surgery who are scheduled to undergo general intravenous anesthesia using remimazolam, we will measure blood levels of remimazolam and its metabolite CNS7054 upon awakening (after completion of remimazolam administration) to determine their pharmacokinetics and to explore factors affecting them.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remimazolam blood concentration at various time points after completion of remimazolam administration
Key secondary outcomes
- Patient information: age, weight, height, BMI, gender, medical history, medications, and laboratory test results
- Surgical information: operation details, operation time, anesthesia time
- Time from the end of remimazolam administration to extubation (awake time)
- Blood concentration of CNS7054 at each time point after completion of remimazolam administration
- Pharmacokinetic parameters such as AUC (area under the blood concentration-time curve) of remimazolam and CNS7054
- BIS values at the end of remimazolam and at the time of extubation or flumazenil administration
- Remimazolam total dose, average rate of administration
- Remifentanil total dose, mean rate of administration
- BIS values before anesthetic administration, during loss of consciousness, and during maintenance of anesthesia
- Time from remimazolam administration to loss of consciousness
- Number of bolus doses 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, 2026.
2. Patients who are able to obtain free and voluntary written consent for participation in the study
3. Patients scheduled for total intravenous anesthesia with remimazolam and remifentanil
4. Patients who are at least 18 years old and less than 50 years old at the time of obtaining consent
5. Patients whose Body Mass Index (BMI) is less than 30
6. Patients whose general condition is PS-1 or PS-2 on the American Society of Anesthesiologists Preoperative Status Classification (ASA-PS).
7. Patients whose scheduled anesthesia time is less than 4 hours.
8. Patients scheduled for dental procedures or minimally invasive oral surgery such as tooth extraction.
9. Patients who are not considered to require narcotic analgesics for postoperative analgesia.
Key exclusion criteria
1. Patients with contraindications to remimazolam, remifentanil, or rocuronium
2. Patients requiring preanesthetic medication
3. Other patients deemed inappropriate for participation in the study by the principal investigator and research coordinators.
Target sample size
40
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
700-8252
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Phamaceutical Scicnoes and Okavama University Hospital, Ethics Committer
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 10 | 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
| 2024 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We explore factors that influence the pharmacokinetics of remimazolam at the emergence.
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062244
