Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

Lund University

Overview

The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating vestibular function prior to surgery, even if vestibular function is absent according to modern assessment techniques

Patients subjected to vestibular schwannoma surgery most often suffer from vertigo after surgery, even if no vestibular function can be found in pre-surgical assessment. According to retrospective data about 33% of patients scheduled for surgery do not have any measurable vestibular function. Even the occurrence of spontaneous nystagmus has been recorded in patients with no or very little function prior to surgery (Parietti-Winkler et al. 2008 JNNP). This indicates that despite new methods of measuring vestibular function, remaining vestibular function can be present and patients might benefit from pre-treatment of gentamicin (Tjernström et al. 2009 JNNP)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Vestibular Schwannoma

Interventions

GentamicinDRUG

Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Vestibular schwannoma advised to surgical treatment * No measurable remaining vestibular function Exclusion Criteria: * impaired decision making * neurofibromatosis * signs for central dysfunction * remaining vestibular function * Patients are advised not to participate in the gentamicin arm if * hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70% * the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss

Locations (1)

Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital

Lund, Sweden

Outcomes

Primary Outcomes

Differences and changes of postural control following surgery, compared to before surgery

Postural control assessed with posturography during a sensory conflict

Time frame: At first vestibular assessment at the time for inclusion and 6 months after surgery

Secondary Outcomes

Occurrence of spontaneous nystagmus after surgery

To measure spontaneous nystagmus and its direction after surgery as a sign of vestibular deafferentation or central nervous damage

Time frame: Day 1 after surgery and for the duration of either spontaneous nystagmus or hospital stay (up to 2 weeks)

Change of hearing levels

Measuring hearing levels (pure tone average and speech discrimination) before and after gentamicin treatment to determine possible detrimental effects on hearing

Time frame: At first vestibular assessment and 4weeks after gentamicin installation

Differences in the level of stress after surgery

Measuring cortisol in the saliva after surgery during the time patients are admitted to the hospital

Time frame: Daily after surgery for the duration of the hospital stay, up to 2 weeks

Differences of subjective well being after surgery

Daily subjective assessment of perceived vertigo/dizziness after surgery

Time frame: Immediate time after surgery (2weeks)

Differences of duration of hospital stay

Length of hospital stay required before patients can be discharged

Time frame: After surgery for the duration of the hospital stay up to 2 weeks

Data from ClinicalTrials.gov

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