Hemifacial Spasm and Desflurane | NCT01726725

Studies
Hemifacial Spasm and Desflurane

NCT01726725

Sponsor

University of Manitoba

Status

Unknown status

Last Update Posted

Nov 16, 2012Estimated

Enrollment

25Estimated

Phase

Not provided

Conditions

Hemifacial Spasm

Interventions

desflurane

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Nov 7, 2012

First Submission Date that Met QC Criteria

Nov 9, 2012

First Posted Date

Nov 15, 2012Estimated

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

Nov 15, 2012

Last Update Posted Date

Nov 16, 2012Estimated

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

Patients are chosen to participate in this study because they will undergo a particular type of brain surgery to treat their hemifacial spasm. This surgery is called microvascular decompression (MVD) and involves the facial nerve. The facial nerve is being compressed by one or more blood vessels and this contact produces the facial twitches. The investigators do not know why a blood vessel that touches the facial nerve produces facial twitches. The investigators are interested in investigating this during your surgery. A total of 25 participants are expected to participate in this study.

Detailed Description

"Intra Operative Monitoring" (IOM) is a standard and routine medical practice for patients having MVD surgery. IOM is done to make sure that the hearing and face nerves are not accidentally bumped or damaged during surgery. After anesthetic induction, the neurophysiologist places electrodes for the nerves, on the scalp and muscles. Stimulation and monitoring of muscle twitches are all common, safe and painless medical procedures.

In this study, the investigators would like to measure the nerve and muscle function on the normal side and compare it to nerve and muscle function on the abnormal side during different levels of the anesthetic desflurane. In order to monitor the normal side of the face one additional set of electrodes will be placed in the facial muscles. The investigators will compare responses to three different levels of anesthetic. The technique used will be motor evoked potentials. The effect of the anesthesia on the lateral spread response will also be examined. This response is evident only on the symptomatic side. These observations will take approximately 10 to 15 minutes and will not delay or lengthen the surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hemifacial spasm, lateral spread, motor evoked potentials		EMG recordings from facial muscles of HFS patients during MVD surgery will be compared during total intravenous anesthesia (propofol), 0.5 MAC desflurane and 1.0 MAC desflurane	Drug: desflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
desflurane	Drug		hemifacial spasm, lateral spread, motor evoked potentials

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients referred to the neurosurgical service for microvascular decompression surgery for HFS
males and females 18 to 75 years of age
otherwise normal neurological exam
signed informed consent

Exclusion Criteria:

Botox treatment within the last three months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with hemifacial spasm who will be undergoing microvascular decompression surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marshall Wilkinson, PhD	University of Manitoba	Principal Investigator

Locations

Not provided

Type	Date	Date Unknown
Release	Dec 1, 2014
Reset	Dec 4, 2014
Release	May 27, 2015
Reset	Jun 10, 2015
Release	Sep 12, 2019
Reset	Oct 2, 2019

Submission Tracking

Estimated Results First Submitted Date

Dec 1, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 1, 2014			Dec 4, 2014
May 27, 2015

Condition Browse Module

MeSH Terms

ID	Term
D019569	Hemifacial Spasm

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D013035	Spasm
D020879	Neuromuscular Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077335	Desflurane

Ancestor Terms

ID	Term
D005019	Ethyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D008738	Methyl Ethers

Browse Leaves

Not provided

Browse Branches

Not provided