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Hemifacial Spasm and Desflurane (HFS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by University of Manitoba.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01726725
First Posted: November 15, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Manitoba
  Purpose
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.

Condition Intervention
Hemifacial Spasm Drug: desflurane

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Investigating the Etiology of Hemifacial Spasm (HFS): The Role of Desflurane

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels [ Time Frame: one year ]

Estimated Enrollment: 25
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with hemifacial spasm who will be undergoing microvascular decompression surgery
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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01726725


Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Marshall Wilkinson, PhD University of Manitoba
  More Information

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01726725     History of Changes
Other Study ID Numbers: B2012:099
First Submitted: November 7, 2012
First Posted: November 15, 2012
Last Update Posted: October 12, 2017
Last Verified: November 2012

Keywords provided by University of Manitoba:
hemifacial spasm
microvascular decompression surgery
desflurane

Additional relevant MeSH terms:
Spasm
Muscle Cramp
Hemifacial Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Mouth Diseases
Stomatognathic Diseases
Desflurane
Isoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs