Hemifacial Spasm and Desflurane (HFS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01726725
First received: November 7, 2012
Last updated: November 15, 2012
Last verified: November 2012
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726725

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

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01726725     History of Changes
Other Study ID Numbers: B2012:099
Study First Received: November 7, 2012
Last Updated: November 15, 2012
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Spasm
Hemifacial Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Desflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014