Neuromuscular Block Monitoring During Monitored Thyroidectomy

October 7, 2021 updated by: I-Cheng Lu, Kaohsiung Medical University Chung-Ho Memorial Hospital

The Feasibility of Routine Neuromuscular Block Monitoring During Monitored Thyroidectomy- A Retrospective Review

Titration of neuromuscular block (NMB) plays a key role in intraoperative recurrent laryngeal nerve monitoring during thyroid surgery. Aim to titrate sugammadex dose based on neuromuscular block degree as a surgeon friendly protocol with high intraoperative neuromonitoring (IONM) quality.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Select
      • Kaohsiung, Select, Taiwan, 807
        • I-Cheng Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In a tertiary medical center and a regional teaching hospital

Description

Inclusion Criteria:

  • elective monitored thyroidectomy

Exclusion Criteria:

  • previous thyroid surgery
  • preexisting vocal cord palsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Deep block
Deep neuromuscular block before initial (V1) vagal stimulation.
Moderate block
Moderate neuromuscular block before initial (V1) vagal stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility in neural monitoring
Time Frame: through surgery completion, an average of 2 hours
EMG amplitude
through surgery completion, an average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of surgical relaxation
Time Frame: through surgery completion, an average of 2 hours
patient movement assessed as severe, mild or none by a departmental scale (none=no movement, mild: any movement did not interfere operation, severe: any movement interrupt operation)
through surgery completion, an average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators

Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ACTUAL)

July 31, 2020

Study Completion (ACTUAL)

July 31, 2021

Study Registration Dates

First Submitted

June 20, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (ACTUAL)

July 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-E(I)-20210070

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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