Adequate Dosage of Sugammadex on Thyroid Surgery

NCT ID: NCT03689413

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-08-28

Brief Summary

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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.

Detailed Description

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Vocal cord paralysis is not a rare complication in thyroid surgery. Nerve monitoring technique has been developed, and many clinicians use the technique for saving the concerned nerves. Many studies showed that the effect of sugammadex on reverse of neuromuscular blocking after tracheal intubation. However, optimal dosage was not founded for sugammadex.

This randomized controlled trial is to compare 1 mg/kg and 2 mg/kg as dosage of sugammadex for optimal continuous intraoperative neuromonitoring in thyroid surgery to prevent vocal cord paralysis.

Conditions

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Thyroid Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1 mg/kg

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.

Group Type EXPERIMENTAL

Sugammadex 200 MG in 2 ML Injection

Intervention Type DRUG

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

2 mg/kg

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.

Group Type ACTIVE_COMPARATOR

Sugammadex 200 MG in 2 ML Injection

Intervention Type DRUG

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

Interventions

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Sugammadex 200 MG in 2 ML Injection

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

Intervention Type DRUG

Other Intervention Names

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Bridion

Eligibility Criteria

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Inclusion Criteria

* The patients who need to open thyroid surgery

Exclusion Criteria

* Who doesn't agree to enroll
* Who has to receive other drug rather than rocuronium for muscle relaxant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Man Lee

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Man Lee, M.D.,PhD

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

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Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 19933538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28349321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28806470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26748952 (View on PubMed)

Other Identifiers

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30-2018-45

Identifier Type: -

Identifier Source: org_study_id

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