UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055235 |
|---|---|
| Receipt number | R000062877 |
| Scientific Title | Study of Sugammadex dose required for antagonism of postoperative neuromuscular blockade. |
| Date of disclosure of the study information | 2024/08/20 |
| Last modified on | 2024/08/13 16:18:17 |
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Basic information
Public title
Study of Sugammadex dose required for antagonism of postoperative neuromuscular blockade.
Acronym
Study of Sugammadex dose required for antagonism of postoperative neuromuscular blockade.
Scientific Title
Study of Sugammadex dose required for antagonism of postoperative neuromuscular blockade.
Scientific Title:Acronym
Study of Sugammadex dose required for antagonism of postoperative neuromuscular blockade.
Region
| Japan |
Condition
Condition
Surgery under general anesthesia with neuromuscular blockade
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to estimate the dose of sugammadex required to antagonize neuromuscular blockade using electromyographic muscle relaxation monitoring, and to observe the occurrence of postoperative re-muscle relaxation.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sugammadex dose required for T1 recovery in muscle relaxation monitoring
Key secondary outcomes
Sugammadex dose required to recover TOF ratio
Dose of sugammadex that does not cause re-muscle relaxation
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases in which surgery is performed under general anesthesia and ICU management is continued under sedation and intubation without awakening the patient after surgery.
Key exclusion criteria
Sugammadex allergy
Hepatic failure
Receiving aminoglycoside antibiotics
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tasuku |
| Middle name | |
| Last name | Fujii |
Organization
Department of Anesthesiology
Division name
anesthesiology
Zip code
466-8560
Address
65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL
052-741-2340
plus9@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Taniguchi |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
466-8560
Address
65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
TEL
052-741-2340
Homepage URL
taniguchi.tomoya.f6@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagoya University Graduate School of Medicine
Address
65 Tsuruna-cho, Showa-ku, Nagoya, 466-8550 Japan
Tel
052-744-2340
ethics@med.nagoya-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 | 08 | 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 | 09 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 25 | 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
Observe the dose of sugammadex required for T1 recovery and the incidence of postoperative muscle relaxation using an electromyographic muscle relaxation monitor
Management information
Registered date
| 2024 | Year | 08 | Month | 13 | Day |
Last modified on
| 2024 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062877
