UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050637 |
|---|---|
| Receipt number | R000057682 |
| Scientific Title | Comparative potentiating effects of remimazolam, propofol and sevoflurane on rocuronium-induced neuromuscular block: a randomised controlled trial |
| Date of disclosure of the study information | 2023/03/20 |
| Last modified on | 2024/05/06 11:55:54 |
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Basic information
Public title
Comparative potentiating effects of remimazolam, propofol and sevoflurane on rocuronium-induced neuromuscular block: a randomised controlled trial
Acronym
Comparative potentiating effects of remimazolam, propofol and sevoflurane on rocuronium-induced neuromuscular block: a randomised controlled trial
Scientific Title
Comparative potentiating effects of remimazolam, propofol and sevoflurane on rocuronium-induced neuromuscular block: a randomised controlled trial
Scientific Title:Acronym
Comparative potentiating effects of remimazolam, propofol and sevoflurane on rocuronium-induced neuromuscular block: a randomised controlled trial
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of neuromuscular block by remimazolam, a sedative indicated for general anaesthesia since 2020 in japan, is not known.The aim of this study was to compare the effects of remimazolam, sevoflurane and propofol on neuromuscular block.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time from administration of rocuronium to first appearance of PTC response
Key secondary outcomes
The time from administration of rocuronium to TOFC0 (onset time), time from administration of rocuronium to first reappearance of TOFC1 (time to TOFC1), time from administration of rocuronium to first reappearance of TOFC2 (time to TOFC2), time from administration of sugammadex to TOF ratio 90% or higher, and blood concentration of rocuronium in the appearance of PTC and TOF.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
For general anaesthetics, the remimazolam is selected by the envelope method. Blood samples are taken at the time of appearance of PTC and TOF to determine the blood concentration of rocuronium.
Interventions/Control_2
For general anaesthetics, the sevoflurane is selected by the envelope method. Blood samples are taken at the time of appearance of PTC and TOF to determine the blood concentration of rocuronium.
Interventions/Control_3
For general anaesthetics, the propofol is selected by the envelope method. Blood samples are taken at the time of appearance of PTC and TOF to determine the blood concentration of rocuronium.
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 American Society of Anesthesiologists physical status classification 1-3.
After receiving written informed consent, patients aged twenty years old or more undergoing surgery with general anesthesia.
Key exclusion criteria
Patients with American Society of Anesthesiologists physical status classification 4 or more, patients with a history of allergic reaction to NMBAs, patients with hepatic disease, patients with neuromuscular disease, and patients who were receiving medication known to interfere with neuromuscular function.
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | Hanae |
| Middle name | |
| Last name | Sato |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
TEL
+81-3-3972-8111
nakamura.hanae@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hanae |
| Middle name | |
| Last name | Sato |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
TEL
+81-3-3972-8111
Homepage URL
nakamura.hanae@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
Tel
+81-3-3972-8111
med.rinsyokenkyu@nihon-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
| 2023 | Year | 03 | Month | 20 | 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
| 2023 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057682
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