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Improvement of Facial Nerve Monitoring in Parotid Surgery by Sugammadex

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ClinicalTrials.gov Identifier: NCT02314234
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
I-Cheng Lu, Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Condition or disease Intervention/treatment
Injury to Nerve During Surgery Drug: sugammadex (Bridion)

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

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Influence of Sugammadex on Facial Nerve Monitoring in Parotid Surgery
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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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




Primary Outcome Measures :
  1. evoked EMG amplitude of facial nerve [ Time Frame: up to first post-op day ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patient with facial nerve monitoring undergoing parotid surgery
Criteria

Inclusion Criteria:

  • undergoing parotid surgery

Exclusion Criteria:

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314234


Locations
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Taiwan
I-Cheng Lu
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital

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Responsible Party: I-Cheng Lu, Visiting staff, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT02314234     History of Changes
Other Study ID Numbers: KMUH-IRB-20140248
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016