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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01726725
Other study ID # B2012:099
Secondary ID
Status Unknown status
Phase N/A
First received November 7, 2012
Last updated November 15, 2012
Start date November 2012
Est. completion date December 2013

Study information

Verified date November 2012
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Unknown status
Enrollment 25
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
desflurane


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Outcome

Type Measure Description Time frame Safety issue
Primary Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels one year
See also
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Unknown status NCT01564979 - Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm Phase 2
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