Improvement of Facial Nerve Monitoring in Parotid Surgery by Sugammadex

February 23, 2016 updated by: I-Cheng Lu, Kaohsiung Medical University Chung-Ho Memorial Hospital

Influence of Sugammadex on Facial Nerve Monitoring in Parotid Surgery

To investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intraoperative neuromonitoring (IONM) of facial nerve has been applied in identifying and preserving facial nerve during parotid surgery. In this setting, even a single dose of nondepolarizing muscle relaxant may lead to delayed and weakened electromyography (EMG) signal in facial nerve monitoring during parotid surgery. The aim of this study was to investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • I-Cheng Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult patient with facial nerve monitoring undergoing parotid surgery

Description

Inclusion Criteria:

  • undergoing parotid surgery

Exclusion Criteria:

  • facial nerve injury, renal failure, liver cirrhosis, neuromuscular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
did not receive muscle relaxant during anesthesia
Sugammadex group
received single dose of rocuronium for anesthesia and sugammadex at skin incision
Drug: sugammadex (Bridion)
single dose of sugammadex at skin incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evoked EMG amplitude of facial nerve
Time Frame: up to first post-op day
up to first post-op day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • KMUH-IRB-20140248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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