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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041735
Receipt No. 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

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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
Email 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
Email moma2@naver.com

Sponsor
Institute Korea university Guro hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047639

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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