NCT04982185

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

June 20, 2021

Last Update Submit

October 7, 2021

Conditions

Thyroid Surgery

Keywords

intraoperative neuromonitoring (IONM)thyroid surgeryneuromuscular block (NMB)

Outcome Measures

Primary Outcomes (1)

  • Feasibility in neural monitoring

    EMG amplitude

    through surgery completion, an average of 2 hours

Secondary Outcomes (1)

  • Quality of surgical relaxation

    through surgery completion, an average of 2 hours

Study Arms (2)

Deep block

Deep neuromuscular block before initial (V1) vagal stimulation.

Moderate block

Moderate neuromuscular block before initial (V1) vagal stimulation.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In a tertiary medical center and a regional teaching hospital

You may qualify if:

  • elective monitored thyroidectomy

You may not qualify if:

  • previous thyroid surgery
  • preexisting vocal cord palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I-Cheng Lu

Kaohsiung City, Select, 807, Taiwan

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 20, 2021

First Posted

July 29, 2021

Study Start

August 1, 2019

Primary Completion

July 31, 2020

Study Completion

July 31, 2021

Last Updated

October 8, 2021

Record last verified: 2021-10

Locations

TW(1)