Intravenous dexamethasone in acute management of vestibular neuronitis

ISRCTN	ISRCTN84838161
DOI	https://doi.org/10.1186/ISRCTN84838161
Protocol serial number	VN001
Sponsor	University Hospital Centre Zagreb (Croatia)
Funder	University Hospital Centre Zagreb (Croatia) - Department of Neurology

Submission date: 22/12/2010
Registration date: 31/03/2011
Last edited: 18/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mario Habek
Scientific

Department of Neurology
Zagreb Medical School and University Hospital Centre
Kispaticeva 12
Zagreb
HR-10000
Croatia

Phone	+385 (0)1 237 6033
Email	mhabek@mef.hr

Study information

Primary study design	Interventional
Study design	Prospective single centre randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Intravenous dexamethasone in acute management of vestibular neuronitis: a prospective single centre randomised placebo controlled trial
Study objectives	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(s)	University Hospital Centre Zagreb Ethical Committee approved on the 29th November 2010
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Dexamethasone, diazepam, thiethylperazine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	15/01/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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])
Key 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
Date of first enrolment	15/01/2011
Date of final enrolment	15/01/2013

Locations

Countries of recruitment

Croatia

Study participating centre

Department of Neurology

Zagreb
HR-10000
Croatia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2016	18/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/01/2019: Publication reference added