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Intravenous dexamethasone in acute management of vestibular neuronitis

Intravenous dexamethasone in acute management of vestibular neuronitis: a prospective single centre randomised placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84838161
Enrollment
100
Registered
2011-03-31
Start date
2011-01-15
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular neuronitis Ear, Nose and Throat Disorders of vestibular function

Interventions

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

Sponsors

University Hospital Centre Zagreb (Croatia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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])

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Croatia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026