Comparison of Sugammadex Dosages to Reverse the Effect of Rocuronium for Continuous Intraoperative Neuromonitoring in Thyroid Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Quality of signal of neuromonitoring
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Sugammadex 200 MG in 2 ML Injection (Drug)
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.
Intervention: Sugammadex 200 MG in 2 ML Injection (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jung-Man Lee
Associate professor
Seoul National University Hospital