The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve

Not Applicable

Completed

• Conditions: Thyroid Intra-Operative Injury
• Interventions: Drug: sugammadex

• Registration Number: NCT03911232
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-11
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-24
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced recovery	sugammadex	rocuronium 2 effective dose at anesthesia induction sugammadex after skin incision and before extubation (total 2 mg/kg iv)

Primary Outcome Measures

Name	Time	Method
sugammadex 2 mg/kg allows effective and rapid restoration of neuromuscular function suppressed by rocuronium	1 month each case	Electromyography signal to assess the quality of neuromonitoring

Trial Locations

Locations (1)

I-Cheng Lu; 🇨🇳 Kaohsiung, Taiwan