Adequate Dosage of Sugammadex on Thyroid Surgery

• ClinicalTrials.gov Identifier: NCT03689413
• Recruitment Status: Completed
• First Posted: September 28, 2018
• Last Update Posted: June 11, 2020
• Sponsor: Seoul National University Hospital
• Collaborator: SMG-SNU Boramae Medical Center
• Information provided by (Responsible Party): Jung-Man Lee, Seoul National University Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Surgery	Drug: Sugammadex 200 MG in 2 ML Injection	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Comparison of Sugammadex Dosages to Reverse the Effect of Rocuronium for Continuous Intraoperative Neuromonitoring in Thyroid Surgery
• Actual Study Start Date: October 1, 2018
• Actual Primary Completion Date: August 28, 2019
• Actual Study Completion Date: August 28, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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 Name: Bridion
Active Comparator: 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.	Drug: 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 Name: Bridion

Outcome Measures

Primary Outcome Measures :

1. Quality of signal of neuromonitoring [ Time Frame: intraoperative ]
   During operation, surgeon evaluate the quality of signal of neuromonitoring on the basis of NIM III device.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• The patients who need to open thyroid surgery

Exclusion Criteria:

• Who doesn't agree to enroll
• Who has to receive other drug rather than rocuronium for muscle relaxant

Contacts and Locations

Locations

Korea, Republic of

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, Korea, Republic of, 07061

Sponsors and Collaborators

Seoul National University Hospital

SMG-SNU Boramae Medical Center

Investigators

• Principal Investigator: Jung-Man Lee, M.D.,PhD; SMG-SNU Boramae Medical Center

More Information

Publications:

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:CD012763. doi: 10.1002/14651858.CD012763. Review.

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.

• Responsible Party: Jung-Man Lee, Associate professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03689413
• Other Study ID Numbers: 30-2018-45
• First Posted: September 28, 2018
• Last Update Posted: June 11, 2020
• Last Verified: June 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jung-Man Lee, Seoul National University Hospital:

neuromonitoring; thyroid surgery

Additional relevant MeSH terms:

Thyroid Diseases; Endocrine System Diseases