The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve

Thyroid Intra-Operative Injury Clinical Trial

Official title:

The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve During Thyroid Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911232
• Other study ID #: KMUH-IRB-E-20150023
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: The use of neuromuscular blocking agent may interfere with the function of intraoperative neuromonitoring (IONM) in thyroid surgery.

Description:

An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a clinically applied during thyroid neural monitoring surgery. In as subsequent clinical application study, 60 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation start. Train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy

Exclusion Criteria:

• Patients with a history of significant cardiac, pulmonary, hepatic, or renal disease, body mass index <18.5 or >35, chronic drug or alcohol abuse

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Intra-Operative Injury

Intervention

Drug:
• sugammadex
standard general anesthesia protocol with sugammadex

Locations

Country	Name	City	State
Taiwan	I-Cheng Lu	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium	Electromyography signal to assess the quality of neuromonitoring	1 month each case