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Completed

NCT Number: NCT03689413

Adequate Dosage of Sugammadex on Thyroid Surgery

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.

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Key information

Conditions

Thyroid Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Bridion

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • SMG-SNU Boramae Medical Center

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2018
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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