Clinical trial · Interventional
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery
Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery and Its Neuroprotective Effect on the Cochlear and Facial Nerve Function
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Vestibular schwannomas are primarily benign (WHO grade I) tumors originating from the Schwann cells of the vestibular nerve and are among the most common tumors of the skull base. Common treatment options are surgical tumor resection or targeted radiation therapy. The special challenge of surgical treatment is the functional preservation of the cranial nerves, especially the cochlear and facial nerves. Perioperative ischemia of the cochlea and cochlear nerve is postulated as the underlying mechanism of postoperative hearing loss. Ischemic preconditioning is a non-invasive procedure that triggers the release of vasoactive cytokines and mediators by repeated short-term induction of limb ischemia. Improved perfusion of critically perfused end organs as well as a reduction of cerebral infarct volumes has already been shown in other pathologies. In the planned study, possible neuroprotective effects of remote ischemic preconditioning on postoperative hearing as well as facial nerve function in patients with vestibular schwannomas will be examined.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remote ischemic preconditioning | Procedure | — | UNRESOLVED |
| Sham-control | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RIC
- description
- On the right upper extremity a blood pressure cuff is inflated to 200mmHg for 4x5min at the beginning of the surgery
- interventionNames
- Procedure: Remote ischemic preconditioning
- type
- SHAM_COMPARATOR
- label
- Control
- description
- On the right upper extremity a blood pressure cuff is inflated to 0mmHg for 4x5min at the beginning of the surgery
- interventionNames
- Procedure: Sham-control
Primary outcomes (1)
- measure
- postoperative hearing
- timeFrame
- 3 months (± 6 weeks) after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * total or gross-total resection of a vestibular schwannoma is planned * Functional hearing is still present on the affected side preoperatively (AEP evocable and Gardner-Robertson grade I, II, or III). * Preoperatively, facial function is unimpaired or mildly impaired (House and Brackmann grade I or II). Exclusion Criteria: * Symptomatic peripheral artery disease. * Active or previous thrombosis in the extremity where the RIC procedure is to be performed. * Neurofibromatosis type 2 * Only planned decompression of the internal auditory canal without relevant tumor resection * Pregnant or breastfeeding females * Previous radiotherapy of the vestibular schwannoma that will be resected
References
Publications (0)
Data not yet available