UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041735 |
|---|---|
| Receipt number | R000047639 |
| Scientific Title | Efficacy and safety of sugammadex for rocuronium-induced neuromuscular blockade in patients with severe renal impairment: A systematic review of observational studies |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2020/09/09 11:46:00 |
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Basic information
Public title
The effect of sugammadex for rocuronium-induced neuromuscular blockade in patients with severe renal impairment
Acronym
sugammadex for patient with severe renal impairment
Scientific Title
Efficacy and safety of sugammadex for rocuronium-induced neuromuscular blockade in patients with severe renal impairment: A systematic review of observational studies
Scientific Title:Acronym
sugammadex for patient with severe renal impairment
Region
| Asia(except Japan) |
Condition
Condition
A systematic review of observational studies
Classification by specialty
| Medicine in general | Anesthesiology | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sugammadex rapidly reverses rocuronium-induced neuromuscular blockade (NMB) by encapsulating rocuronium, making a sugammadex-rocuronium complex that is eliminated by kidney. In patients with severe renal impairment, pharmacokinetics of both rocuronium and sugammadex would be altered, and thus the NMB reversal by sugammadex would be unpredictable or imcomplete. Therefore, we aimed to examine the efficacy, pharmacokinetics and postoperative respiratory complications of sugammadex in patients with severe renal impairment undergoing general anesthesia using a systematic review framework.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is mean times taken to reach a train of four ratio more than 0.9, 0.8 and 0.7.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged more than18 years scheduled to undergo a surgical procedure using rocuronium for neuromuscular blockade (NMB) and sugammadex for NMB reversal during general anesthesia
The relevant case-control studies with sugammadex treatment to patients with severe renal impairment (group R) compared to patients with normal renal function (group N).
Key exclusion criteria
Neostigmine treatment study, pediatrics study
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Young Ju |
| Middle name | |
| Last name | Won |
Organization
Korea university Guro hospital
Division name
Department of the anesthesia and pain medicine
Zip code
06009
Address
Gurodong ro 148 guro gu , Seoul
TEL
082-2-2626-1437
moma2@naver.com
Public contact
Name of contact person
| 1st name | Young Ju |
| Middle name | |
| Last name | Won |
Organization
Korea university Guro hospital
Division name
Department of the anesthesia and pain medicine
Zip code
06009
Address
Gurodong ro 148, guro gu, SEoul
TEL
082-2-2626-1437
Homepage URL
moma2@naver.com
Sponsor or person
Institute
Korea university Guro hospital
Institute
Department
Personal name
Funding Source
Organization
Korea university
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
korea university guro hospital
Address
Gurodong ro 148, Guro gu, Seoul
Tel
02-2626-1632
o-kwon@korea.ac.kr
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 | 06 | 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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
meta-analysis
Management information
Registered date
| 2020 | Year | 09 | Month | 09 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047639
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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