Adequate Dosage of Sugammadex on Thyroid Surgery

Not Applicable

Completed

• Conditions: Thyroid Surgery
• Interventions: Drug: Sugammadex 200 MG in 2 ML Injection

• Registration Number: NCT03689413
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Study Start: 2018-10-01
• Primary Completion: 2019-08-28
• Study Completion: 2019-08-28
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 mg/kg	Sugammadex 200 MG in 2 ML Injection	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.
1 mg/kg	Sugammadex 200 MG in 2 ML Injection	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.

Primary Outcome Measures

Name	Time	Method
Quality of signal of neuromonitoring	intraoperative	During operation, surgeon evaluate the quality of signal of neuromonitoring on the basis of NIM III device.

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of