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| Name | Class |
|---|---|
| SMG-SNU Boramae Medical Center | OTHER |
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This study was designed to compare two dosage of sugammadex after tracheal intubation for optimal condition of continuous intraoperative neuromonitoring in thyroid surgery to protect recurrent laryngeal nerve.
Vocal cord paralysis is not a rare complication in thyroid surgery. Nerve monitoring technique has been developed, and many clinicians use the technique for saving the concerned nerves. Many studies showed that the effect of sugammadex on reverse of neuromuscular blocking after tracheal intubation. However, optimal dosage was not founded for sugammadex.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg/kg | Experimental | 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. |
|
| 2 mg/kg | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex 200 MG in 2 ML Injection | Drug | 1 mg/kg or 2 mg/kg intravenous injection for each group (1 mg/kg group, 2 mg/kg group) after tracheal intubation |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of signal of neuromonitoring | During operation, surgeon evaluate the quality of signal of neuromonitoring on the basis of NIM III device. | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Man Lee, M.D.,PhD | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | 07061 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19933538 | Background | 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. | |
| 28349321 |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D007267 | Injections |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| 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. |
| 28806470 | Background | 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. |
| 26748952 | Background | 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. |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |