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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016602
Receipt No. R000019266
Scientific Title Comparison of sugammadex and pyridostigmine for reversal of neuromuscular blockade in the absence of neuromuscular monitoring in patients undergoing laryngeal microsurgery: A single-centered retrospective study
Date of disclosure of the study information 2015/02/22
Last modified on 2015/09/23

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Basic information
Public title Comparison of sugammadex and pyridostigmine for reversal of neuromuscular blockade in the absence of neuromuscular monitoring in patients undergoing laryngeal microsurgery: A single-centered retrospective study
Acronym Effectiveness of sugammadex in the absence of neuromuscular monitoring
Scientific Title Comparison of sugammadex and pyridostigmine for reversal of neuromuscular blockade in the absence of neuromuscular monitoring in patients undergoing laryngeal microsurgery: A single-centered retrospective study
Scientific Title:Acronym Effectiveness of sugammadex in the absence of neuromuscular monitoring
Region
Asia(except Japan)

Condition
Condition elective laryngeal microsurgery
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to investigate whether sugammadex shortens recovery times and reduces postoperative adverse events compared with pyridostigmine when the administration of rocuronium and its reversal agent is not guided by neuromuscular monitoring.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes anesthesia and extubation time
Key secondary outcomes the total amount of rocuronium and reversal agents, the interval between the surgery end time and the administration of reversal agents, recovery time [the time to reach modified Aldrete score 10] in the postanesthesia care unit and postoperative adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sugammadex reversal group
Interventions/Control_2 pyridostigmine reversal group
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
20 years-old <
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria patients with the American Society of Anesthesiologists physical status 1 or 2, undergoing elective laryngeal microsurgery,
patients who receive rocuronium for neuromuscular block and sugammadex or pyridostigmine for reversal of neuromuscular block
Key exclusion criteria patients with renal or hepatic impairment and extremely elderly patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Byung Gun Lim
Organization Korea University Guro Hospital, Korea University College of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL 82226261437
Email bglim9205@korea.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Byung Gun Lim
Organization Korea University Guro Hospital, Korea University College of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL 82226261437
Homepage URL
Email bglim9205@korea.ac.kr

Sponsor
Institute Korea University
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
Address
Tel
Email

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 Korea University Guro Hospital

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 22 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 Completed
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 22 Day
Last modified on
2015 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019266

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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