UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055545 |
|---|---|
| Receipt number | R000060982 |
| Scientific Title | Determination of ED95 of remimazolam to achieve loss of consciousness during anesthesia induction in obesity patients |
| Date of disclosure of the study information | 2024/10/25 |
| Last modified on | 2025/03/21 15:12:46 |
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Basic information
Public title
Determination of ED95 of remimazolam to achieve loss of consciousness during anesthesia induction in obesity patients
Acronym
RMMINDUCTION1
Scientific Title
Determination of ED95 of remimazolam to achieve loss of consciousness during anesthesia induction in obesity patients
Scientific Title:Acronym
RMMINDUCTION1
Region
| Asia(except Japan) |
Condition
Condition
Obese patient, ASA class I,II
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to evaluate the 95% effective dose of a single bolus injection of remimazolam administered for loss of consciousness in obese patients undergoing surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ED95 of remimazolam
Key secondary outcomes
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
among obese patients, ASA I,II over 19 years old,
body mass index over 30kg/m2
Key exclusion criteria
Patients allergic to benzodiazepines
Patients who regularly use sleeping pills, benzodiazepines, opioids, or alcohol
Patients with communication difficulties (ex. hearing impairment, dementia, etc.)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | In-Ae |
| Middle name | |
| Last name | Song |
Organization
Seoul national university Bundang hospital
Division name
Anesthesiology and Pain medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, South Korea
TEL
+82317877499
sia1@snubh.org
Public contact
Name of contact person
| 1st name | Jiyoun |
| Middle name | |
| Last name | Lee |
Organization
Seoul national university Bundang hospital
Division name
Anesthesiology and Pain medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, South Korea
TEL
+82317877499
Homepage URL
heykiki1@hanmail.net
Sponsor or person
Institute
Seoul national university Bundang hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seoul national university Bundang hospital
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, South Korea
Tel
+82317878801
snubhirb@gmail.com
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 | 10 | Month | 25 | 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
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
According to a previous study,0.2mg/kg of Remimazolam was used as the initial anesthesia induction dose. To determine the dose of the next patient, we used a biased coin design introduced by Durham et al.
Management information
Registered date
| 2024 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060982
