UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016602 |
|---|---|
| Receipt number | 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 15:29:39 |
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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
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
bglim9205@korea.ac.kr
Sponsor or person
Institute
Korea University
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019266
