Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function
- Conditions
- Vestibular Schwannoma
- Interventions
- Drug: Gentamicins
- Registration Number
- NCT02379754
- Lead Sponsor
- Lund University
- Brief Summary
The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.
- Detailed Description
The residual function of the vestibular system before surgery differs considerably between patients, due to extent and influence of tumor growth, resulting in varying spectra of post-surgery illness as well as vestibular symptoms. An acute unilateral vestibular deafferentation (uVD) (if significant vestibular function remains prior to surgery) invariably results in severe nausea and vertigo. The nausea/vertigo induced by surgery and sudden uVD both can impede vestibular compensation processes and in extension, also the need for rehabilitation. The vestibular PREHAB protocol was developed in order to address this problem and to ensure an enhanced and sufficient rehabilitation. The protocol encompass treating patients that have measurable vestibular function before surgery with intratympanic gentamicin injections, thus producing gradually a uVD over a period of 3-4 weeks, whilst performing daily vestibular exercises before and after the gentamicin treatment. Through this procedure the sensory trauma is separated from the surgical trauma, making it possible for vestibular compensation to ensue as the vestibular function gradually decline from gentamicin toxicity, unencumbered by any depression of central nervous function that might result from schwannoma surgery or the acute stages of an uVD.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- diagnosed with vestibular schwannoma and surgical treatment is advised
- remaining vestibular function
- impaired decision making
- no remaining vestibular function
- signs of central nervous dysfunction
- neurofibromatosis
- Patients are advised not to participate in the gentamicin arm but encouraged to participate in the 'non-gentamicin' arm:
- when hearing is better than 30decibel (dB) i pure tone average (500, 1000, 2000, 3000/4000 Hz) and speech discrimination better than 70% -when the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin- associated hearing loss
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gentamicin treated Gentamicins 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.
- Primary Outcome Measures
Name Time Method Differences and changes of postural control following surgery, compared to before surgery At first vestibular assessment at the time for inclusion and 6 months after surgery Postural control assessed with posturography during a sensory conflict
- Secondary Outcome Measures
Name Time Method Differences of perceived dizziness after surgery 6 months after surgery Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)
Differences of changes in levels of perceived dizziness after surgery as compared to before surgery At first vestibular assessment and 6 months after surgery Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)
Differences in vestibular compensation after surgery 6 months after surgery Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation after surgery
Change of vestibular function after gentamicin treatment 6weeks after gentamicin treatment Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation and function after gentamicin treatment
Differences of duration of hospital stay After surgery for the duration of the hospital stay up to two weeks Hospital stay required before patients can be discharged
Differences of subjective well being after surgery Immediate time after surgery (2 weeks) Daily subjective assessment of perceived vertigo/dizziness after surgery and gentamicin treatment
Change of hearing levels At first vestibular assessment and 2 weeks after gentamicin installation Measuring hearing levels (pure tone hearing and speech discrimination) before and after gentamicin treatment to determine possible detrimental effect on hearing
Change of subjective well being after gentamicin treatment Immediate time after gentamicin installation (2 weeks) Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment
Differences in the level of stress after surgery Daily after surgery for the duration of the hospital stay up to 2 weeks Daily Measures of cortisol in the saliva after surgery during the time patients are admitted to the hospital
Change of level of perceived dizziness after gentamicin At first vestibular assessment and 6 weeks after gentamicin installation Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)
Differences of level of anxiety and depression 6 months after surgery Measure of level of anxiety and depression after surgery, enquiry with Hospital Anxiety and Depression Scale (HADS)
Occurrence of spontaneous nystagmus after surgery Day 1 after surgery and for duration of either spontaneous nystagmus or hospital stay (up to 2 weeks) To measure spontaneous nystagmus after surgery and its direction as a sign of vestibular deafferentation or central nervous damage
Trial Locations
- Locations (1)
Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital
🇸🇪Lund, Sweden