UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044900 |
|---|---|
| Receipt number | R000051283 |
| Scientific Title | Recovery of psychomotor function after total intravenous anesthesia with propofol or remimazolam: a parallel-group comparison |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/07/19 12:13:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Recovery of psychomotor function after total intravenous anesthesia with propofol or remimazolam
Acronym
Comparison of recovery of remimazolam and propofol
Scientific Title
Recovery of psychomotor function after total intravenous anesthesia with propofol or remimazolam: a parallel-group comparison
Scientific Title:Acronym
Remimazolam study
Region
| Japan |
Condition
Condition
Patients scheduled to undergo endoscopic sinus surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
After propofol or remimazolam anesthesia, Trieger dot test will be performed.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trieger dot test 30,60,90,120,150,180 min after general anesthesia.
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Remimazolam group: 30
Interventions/Control_2
Propofol group: 30
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ASA physical status I or II aged 20-65 years who will be scheduled to undergo elective otorhinolaryngological surgery.
Key exclusion criteria
Patients who have an allergy with propofol or remimazolam, glaucoma, myasthenia gravis,drug addiction or cerebral dysfunction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Shimizu |
Organization
Dokkyo Medical University Hospital
Division name
Anesthesiology
Zip code
3210293
Address
880 Kitakobayashi, Mibu , Tochigi, Japan
TEL
0282-86-1111
takasusu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Takasusuki |
Organization
Dokkyo Medical University
Division name
Anesthesiology
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282861111
Homepage URL
takasusu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
No
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
Dokkyo Medical University Hospital
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
Tel
0282861111
takasusu@dokkyomed.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 | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | 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 | 07 | Month | 19 | Day |
Last modified on
| 2021 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051283
