Improvement of Facial Nerve Monitoring in Parotid Surgery... | NCT02314234

Studies
Improvement of Facial Nerve Monitoring in Parotid Surgery by Sugammadex

NCT02314234

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Completed

Last Update Posted

Feb 25, 2016Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Injury to Nerve During Surgery

Interventions

sugammadex (Bridion)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 4, 2014

First Submission Date that Met QC Criteria

Dec 8, 2014

First Posted Date

Dec 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2016

Last Update Posted Date

Feb 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

I-Cheng Lu, Visiting staff, Kaohsiung Medical University Chung-Ho Memorial HospitalPrincipal Investigator

Lead Sponsor

Kaohsiung Medical University Chung-Ho Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sugammadex (Bridion)	Drug	single dose of sugammadex at skin incision	Sugammadex group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

undergoing parotid surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

adult patient with facial nerve monitoring undergoing parotid surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
I-Cheng Lu		Kaohsiung City		807	Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D000077122	Sugammadex

Ancestor Terms

ID	Term
D047408	gamma-Cyclodextrins
D003505	Cyclodextrins
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided