UMIN-CTR Clinical Trial

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