Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2018-10-01
2019-08-28
Brief Summary
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Detailed Description
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This randomized controlled trial is to compare 1 mg/kg and 2 mg/kg as dosage of sugammadex for optimal continuous intraoperative neuromonitoring in thyroid surgery to prevent vocal cord paralysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1 mg/kg
For '1 mg/kg' group, sugammadex of 1 mg/kg (ex. 60 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation.
We will use Sugammadex 200 MG in 2 ML Injection for this.
Sugammadex 200 MG in 2 ML Injection
1 mg/kg or 2 mg/kg intravenous injection for each group (1 mg/kg group, 2 mg/kg group) after tracheal intubation
2 mg/kg
For '2 mg/kg' group, sugammadex of 2 mg/kg (ex. 120 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation.
We will use Sugammadex 200 MG in 2 ML Injection for this.
Sugammadex 200 MG in 2 ML Injection
1 mg/kg or 2 mg/kg intravenous injection for each group (1 mg/kg group, 2 mg/kg group) after tracheal intubation
Interventions
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Sugammadex 200 MG in 2 ML Injection
1 mg/kg or 2 mg/kg intravenous injection for each group (1 mg/kg group, 2 mg/kg group) after tracheal intubation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Who has to receive other drug rather than rocuronium for muscle relaxant
18 Years
ALL
No
Sponsors
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SMG-SNU Boramae Medical Center
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Jung-Man Lee
Associate professor
Principal Investigators
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Jung-Man Lee, M.D.,PhD
Role: PRINCIPAL_INVESTIGATOR
SMG-SNU Boramae Medical Center
Locations
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Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, , South Korea
Countries
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References
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Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.
Empis de Vendin O, Schmartz D, Brunaud L, Fuchs-Buder T. Recurrent Laryngeal Nerve Monitoring and Rocuronium: A Selective Sugammadex Reversal Protocol. World J Surg. 2017 Sep;41(9):2298-2303. doi: 10.1007/s00268-017-4004-9.
Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.
Lu IC, Wu CW, Chang PY, Chen HY, Tseng KY, Randolph GW, Cheng KI, Chiang FY. Reversal of rocuronium-induced neuromuscular blockade by sugammadex allows for optimization of neural monitoring of the recurrent laryngeal nerve. Laryngoscope. 2016 Apr;126(4):1014-9. doi: 10.1002/lary.25577. Epub 2016 Jan 9.
Other Identifiers
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30-2018-45
Identifier Type: -
Identifier Source: org_study_id
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