Adequate Dosage of Sugammadex on Thyroid Surgery

Seoul National University

Status: Completed

Conditions: Thyroid Surgery

Treatments: Drug: Sugammadex 200 MG in 2 ML Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03689413

30-2018-45

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

1 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Sugammadex 200 MG in 2 ML Injection

2 mg/kg

Active Comparator group

Description:

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.

Treatment:

Drug: Sugammadex 200 MG in 2 ML Injection