NCT03911232

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2016

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

December 5, 2016

Last Update Submit

June 24, 2021

Conditions

Thyroid Intra-Operative Injury

Keywords

intraoperative neural monitoring

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Enhanced recovery

EXPERIMENTAL

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

Drug: sugammadex

Conventional anesthesia

NO INTERVENTION

standard general anesthesia protocol (1 effective dose of rocuronium at anesthesia induction)

Interventions

sugammadexDRUG

standard general anesthesia protocol with sugammadex

Also known as: Bridion
Enhanced recovery

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I-Cheng Lu

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 5, 2016

First Posted

April 11, 2019

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)