Contact information
Type
Scientific
Primary contact
Dr Mario Habek
ORCID ID
Contact details
Department of Neurology
Zagreb Medical School and University Hospital Centre
Kispaticeva 12
Zagreb
HR-10000
Croatia
+385 (0)1 237 6033
mhabek@mef.hr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
VN001
Study information
Scientific title
Intravenous dexamethasone in acute management of vestibular neuronitis: a prospective single centre randomised placebo controlled trial
Acronym
Study hypothesis
Intravenous administration of dexamethasone in combination with vestibular suppressant (diazepam) and antiemetic (thiethylperazine) leads to a quicker recovery of clinical symptoms in patients with vestibular neuronitis (VN) when compared to administration of vestibular suppressant (diazepam) and antiemetic (thiethylperazine).
Ethics approval
University Hospital Centre Zagreb Ethical Committee approved on the 29th November 2010
Study design
Prospective single centre randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Vestibular neuronitis
Intervention
All patients who are diagnosed as VN and have signed informative consent forms will be randomised in one of two groups (A or B):
1. Patients in group A will receive dexamethasone 12 mg intravenous (i.v.), diazepam 10 mg in 500 ml saline and thiethylperazine 10 mg subcutaneously (s.c.)
2. Patients in group B will receive placebo saline i.v., diazepam 10 mg in 500 ml saline and thiethylperazine 10 mg s.c.
The duration of treatment is one hour in the emergency department. Follow up is 4 hours in the emergency department, and there is follow up visit one month after.
Intervention type
Drug
Phase
Not Applicable
Drug names
Dexamethasone, diazepam, thiethylperazine
Primary outcome measure
Necessity to hospitalise patients who present with VN in the emergency department.
All outcomes will be measured at the admittance to the emergency department and 120 mins after the treatment.
Secondary outcome measures
1. Improvement of nystagmus (grading by Alexander)
2. Improvement of postural instability (grading by Fukuda test)
3. Lessening of nausea (according of visual-analog scale)
4. Lessening of vomiting
5. Recovery of subjective symptoms (according to European Evaluation of Vertigo scale)
All outcomes will be measured at the admittance to the emergency department and 120 mins after the treatment.
Overall trial start date
15/01/2011
Overall trial end date
15/01/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients older than 18 years of age (either sex) who will be diagnosed as vestibular neuronitis in the emergency neurology department based on the following criteria:
1. Persistent rotatory vertigo which started up to 48 hours
2. Horisontal-torsional nystagmus, unidirectional, more pronounced on removing fixation
3. Positive head thrust test on the side of vestibular lesion
4. Absence of skew deviation (assessed by Maddox rod test)
5. Normal brain multi-slice computed tomography (MSCT)
6. Normal electrocardiogram (ECG)
7. Normal laboratory findings (complete blood count [CBC], prothrombin time [PT], activated partial thromboplastin time [APTT], blood glucose level, urea, creatinine, aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT], creatine kinase [CK], lactate dehydrogenase [LD])
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Loss of hearing
2. Tinnitus
3. Presence of any neurological deficit
4. Medical history containing data of:
4.1. Unregulated arterial hypertension
4.2. Atrial fibrillation
4.3. Diabetes mellitus
5. Patients taking:
5.1. Corticosteroids
5.2. Benzodiazepines
5.3. Patients who have contraindications for taking corticosteroids and benzodiazepines
Recruitment start date
15/01/2011
Recruitment end date
15/01/2013
Locations
Countries of recruitment
Croatia
Trial participating centre
Department of Neurology
Zagreb
HR-10000
Croatia
Sponsor information
Organisation
University Hospital Centre Zagreb (Croatia)
Sponsor details
Department of Neurology
Kispaticeva 12
Zagreb
HR-10000
Croatia
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Centre Zagreb (Croatia) - Department of Neurology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/25919484 (added 18/01/2019)