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Adequate Dosage of Sugammadex on Thyroid Surgery

Comparison of Sugammadex Dosages to Reverse the Effect of Rocuronium for Continuous Intraoperative Neuromonitoring in Thyroid Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03689413
Enrollment
102
Registered
2018-09-28
Start date
2018-10-01
Completion date
2019-08-28
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Surgery

Keywords

neuromonitoring, thyroid surgery

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.

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.

Interventions

1 mg/kg or 2 mg/kg intravenous injection for each group (1 mg/kg group, 2 mg/kg group) after tracheal intubation

Sponsors

SMG-SNU Boramae Medical Center
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of signal of neuromonitoringintraoperativeDuring operation, surgeon evaluate the quality of signal of neuromonitoring on the basis of NIM III device.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026