The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve

NCT ID: NCT03911232

Last Updated: 2021-06-30

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a clinically applied during thyroid neural monitoring surgery. In as subsequent clinical application study, 60 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation start. Train-of-four (TOF) ratio was used for continuous quantitative monitoring of neuromuscular transmission.

Conditions

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Thyroid Intra-Operative Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Enhanced recovery

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

Group Type EXPERIMENTAL

sugammadex

Intervention Type DRUG

standard general anesthesia protocol with sugammadex

Conventional anesthesia

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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sugammadex

standard general anesthesia protocol with sugammadex

Intervention Type DRUG

Other Intervention Names

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Bridion

Eligibility Criteria

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Inclusion Criteria

* patients undergoing intraoperative neuromonitoring of recurrent laryngeal nerve during thyroidectomy

Exclusion Criteria

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

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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I-Cheng Lu

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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I-Cheng Lu

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUH-IRB-E-20150023

Identifier Type: -

Identifier Source: org_study_id

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