Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

Lund University

Status and phase: Withdrawn; Phase 4

Conditions: Vestibular Schwannoma

Treatments: Drug: Gentamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02415257

VS-FT-02

Details and patient eligibility

About

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

Full description

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)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Gentamicin treated

Experimental group

Description:

Installation of gentamicin in the middle ear 6 weeks prior to surgery + rehabilitation exercises before and after both treatment and surgery. Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented and exclusion from exercises would not be approved by the ethical board

Treatment:

Drug: Gentamicin

Non-gentamicin

No Intervention group

Description:

Rehabilitation exercises before and after both treatment and surgery Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented and exclusion from exercises would not be approved by the ethical board