NCT03689413

Brief Summary

This study was designed to compare two dosage of sugammadex after tracheal intubation for optimal condition of continuous intraoperative neuromonitoring in thyroid surgery to protect recurrent laryngeal nerve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

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

First Submitted

Initial submission to the registry

September 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

September 27, 2018

Last Update Submit

June 8, 2020

Conditions

Thyroid Surgery

Keywords

neuromonitoringthyroid surgery

Outcome Measures

Primary Outcomes (1)

  • Quality of signal of neuromonitoring

    During operation, surgeon evaluate the quality of signal of neuromonitoring on the basis of NIM III device.

    intraoperative

Study Arms (2)

1 mg/kg

EXPERIMENTAL

For '1 mg/kg' group, sugammadex of 1 mg/kg (ex. 60 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation. We will use Sugammadex 200 MG in 2 ML Injection for this.

Drug: Sugammadex 200 MG in 2 ML Injection

2 mg/kg

ACTIVE COMPARATOR

For '2 mg/kg' group, sugammadex of 2 mg/kg (ex. 120 mg for 60 kg patient) will be administered to the assigned patient for this group after tracheal intubation. We will use Sugammadex 200 MG in 2 ML Injection for this.

Drug: Sugammadex 200 MG in 2 ML Injection

Interventions

Sugammadex 200 MG in 2 ML InjectionDRUG

1 mg/kg or 2 mg/kg intravenous injection for each group (1 mg/kg group, 2 mg/kg group) after tracheal intubation

Also known as: Bridion
1 mg/kg2 mg/kg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who need to open thyroid surgery

You may not qualify if:

  • Who doesn't agree to enroll
  • Who has to receive other drug rather than rocuronium for muscle relaxant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Related Publications (4)

  • Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.

    PMID: 19933538BACKGROUND

  • Empis de Vendin O, Schmartz D, Brunaud L, Fuchs-Buder T. Recurrent Laryngeal Nerve Monitoring and Rocuronium: A Selective Sugammadex Reversal Protocol. World J Surg. 2017 Sep;41(9):2298-2303. doi: 10.1007/s00268-017-4004-9.

    PMID: 28349321BACKGROUND

  • Hristovska AM, Duch P, Allingstrup M, Afshari A. Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults. Cochrane Database Syst Rev. 2017 Aug 14;8(8):CD012763. doi: 10.1002/14651858.CD012763.

    PMID: 28806470BACKGROUND

  • Lu IC, Wu CW, Chang PY, Chen HY, Tseng KY, Randolph GW, Cheng KI, Chiang FY. Reversal of rocuronium-induced neuromuscular blockade by sugammadex allows for optimization of neural monitoring of the recurrent laryngeal nerve. Laryngoscope. 2016 Apr;126(4):1014-9. doi: 10.1002/lary.25577. Epub 2016 Jan 9.

    PMID: 26748952BACKGROUND

MeSH Terms

Interventions

SugammadexInjections

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Jung-Man Lee, M.D.,PhD

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 27, 2018

First Posted

September 28, 2018

Study Start

October 1, 2018

Primary Completion

August 28, 2019

Study Completion

August 28, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

KR(1)