Intraoperative brainstem auditory evoked potential pattern and perioperative vasoactive treatment for hearing preservation in vestibular schwannoma surgery

Bischoff, Barbara; Romstöck, J.; Fahlbusch, Rudolf; Buchfelder, Michael; Strauß, Christian

doi:10.1136/jnnp.2006.113449

Cited by 41 publications

(40 citation statements)

References 33 publications

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“…2,20,21,24,25 Furthermore, these positive results were also observed in laryngeal 8,14 and maxillofacial surgery 23 and may therefore be transferable to other surgical procedures with nerves at risk.…”

Section: Generalizabilitymentioning

confidence: 79%

“…However, when intraoperative monitoring indicated deterioration of facial or cochlear nerve function, an intraoperative start of the neuroprotective therapy in the control group was permitted because of its beneficial effect in previous studies. 2,20,21,24,25 Therefore, neuroprotective therapy was started intraoperatively in 17 patients in the control group.…”

Section: Interventionsmentioning

confidence: 99%

“…2,20,24,25 The last patient was included before the "Public Workshop: Risks and Benefits of Hydroxyethyl Starch Solutions" of the FDA had taken place. Although Voluven 6% is approved by the FDA and no adverse events related to HES (especially renal toxicity) were observed in the present study, the neuroprotective effect of HES is questionable, taking into consideration that animal experiments and clinical trials using nimodipine alone showed evidence of comparable neuroprotective efficacy.…”

Section: Study Medicationmentioning

confidence: 99%

“…16 Therefore, nimodipine was administered to patients with loss or deterioration of intraoperative brainstem auditory evoked potential patterns in vestibular schwannoma surgery (off-label use). 2,24 Several authors following retro-and prospective clinical trials revealed a beneficial effect of nimodipine and hydroxyethyl starch (HES) on long-term outcome of cranial nerve function following VS surgery. 2,21,24,25 A pilot study showed a superiority of its prophylactic administration compared with an intraoperative start or no treatment.…”

mentioning

confidence: 99%

“…2,24 Several authors following retro-and prospective clinical trials revealed a beneficial effect of nimodipine and hydroxyethyl starch (HES) on long-term outcome of cranial nerve function following VS surgery. 2,21,24,25 A pilot study showed a superiority of its prophylactic administration compared with an intraoperative start or no treatment. 20 The present Phase III trial was undertaken to examine whether prophylactic nimodipine and HES are beneficial in patients undergoing VS surgery.…”

mentioning

confidence: 99%

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Prophylactic nimodipine treatment for cochlear and facial nerve preservation after vestibular schwannoma surgery: a randomized multicenter Phase III trial

Scheller¹,

Wienke

Tatagiba

et al. 2016

JNS

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obJective A pilot study of prophylactic nimodipine and hydroxyethyl starch treatment showed a beneficial effect on facial and cochlear nerve preservation following vestibular schwannoma (VS) surgery. A prospective Phase III trial was undertaken to confirm these results. methods An open-label, 2-arm, randomized parallel group and multicenter Phase III trial with blinded expert review was performed and included 112 patients who underwent VS surgery between January 2010 and February 2013 at 7 departments of neurosurgery to investigate the efficacy and safety of the prophylaxis. The surgery was performed after the patients were randomly assigned to one of 2 groups using online randomization. The treatment group (n = 56) received parenteral nimodipine (1-2 mg/hr) and hydroxyethyl starch (hematocrit 30%-35%) from the day before surgery until the 7th postoperative day. The control group (n = 56) was not treated prophylactically. results Intent-to-treat analysis showed no statistically significant effects of the treatment on either preservation of facial nerve function (35 [ ]) (p = 0.530) 12 months after surgery. Since tumor sizes were significantly larger in the treatment group than in the control group, logistic regression analysis was required. The risk for deterioration of facial nerve function was adjusted nearly the same in both groups ], p = 0.91). In contrast, the risk for postoperative hearing loss was adjusted 2 times lower in the treatment group compared with the control group (OR 0.49 [95% CI 0.18-1.30], p = 0.15). Apart from dosedependent hypotension (p < 0.001), no clinically relevant adverse reactions were observed. coNclusioNs There were no statistically significant effects of the treatment. Despite the width of the confidence intervals, the odds ratios may suggest but do not prove a clinically relevant effect of the safe study medication on the preservation of cochlear nerve function after VS surgery. Further study is needed before prophylactic nimodipine can be recommended in VS surgery.Clinical trial registration no.: 2009-012088-32 (www.clinicaltrialsregister.eu)

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