UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055546 |
|---|---|
| Receipt number | R000063119 |
| Scientific Title | Comparison between Remimazolam and Dexmedetomidine in patients undergoing Monitored Anesthesia Care for cataract surgery. |
| Date of disclosure of the study information | 2024/10/19 |
| Last modified on | 2025/03/21 15:13:18 |
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Basic information
Public title
Comparison between Remimazolam and Dexmedetomidine in patients undergoing Monitored Anesthesia Care for cataract surgery.
Acronym
CRDMAC
Scientific Title
Comparison between Remimazolam and Dexmedetomidine in patients undergoing Monitored Anesthesia Care for cataract surgery.
Scientific Title:Acronym
CRDMAC
Region
| Asia(except Japan) |
Condition
Condition
cataract surgery, Monitoreed Anestehsia Care
Classification by specialty
| Ophthalmology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to compare the efficacy and safety of Remimazolam versus Dexmedetomidine in patients undergoing cataract surgery under monitored anesthesia care (MAC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery time after MAC (time required to achieve a PADS score of 9 or higher)
Key secondary outcomes
Patient Satisfaction and Surgeon Satisfaction
Vital Signs: Blood pressure, heart rate, oxygen saturation (during anesthesia, post-anesthesia)
Type and Dosage of Medications Used: Anesthetics, vasopressors, others
Anesthesia Recovery Record
Vital Signs During Anesthesia and Recovery: Blood pressure, heart rate, oxygen saturation
Recovery Profile
Adverse Effects: Nausea/vomiting, apnea, hypotension, arrhythmia, hypoxemia, conversion of anesthesia method, unplanned hospital admission, use of vasopressors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but 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
Dexmedetomidine
Interventions/Control_2
Remimazolam
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
Adult patients aged 19 years and older scheduled for ophthalmic surgery under MAC
ASA class 1.2.3
Key exclusion criteria
ASA class 4 or higher
Pregnant women
Patients with preexisting renal or hepatic dysfunction
Patients with severe heart failure or coronary artery disease requiring treatment
Patients with known drug hypersensitivity to dexmedetomidine or remimazolam
Patients who do not consent to participate in this study
Patients with limited ability to understand and complete the study consent form and questionnaires
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Jiyoun |
| Middle name | |
| Last name | Lee |
Organization
Seoul National University Bundang Hospital
Division name
Anesthesia and Pain Medicine
Zip code
13620
Address
82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL
0317873640
heykiki1@hanmail.net
Public contact
Name of contact person
| 1st name | Jiyoun |
| Middle name | |
| Last name | Lee |
Organization
Seoul National University Bundang Hospital
Division name
Anesthesia and Pain Medicine
Zip code
13620
Address
82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
TEL
0317873640
Homepage URL
heykiki1@hanmail.net
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
Seoul National University Bundang Hospital
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
Seoul National University Bundang Hospital
Address
82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Tel
0317878801
heykiki1@hanmail.net
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 | 19 | 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 | 09 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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=R000063119
