Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery

NCT05567341 | Unknown DMC

• 1 other identifier: 489-0-0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Vestibular Schwannoma

Keywords

remote ischemic preconditioning; cochlear nerve; facial nerve; hearing; vestibular schwannoma surgery

Outcome Measures

Primary Outcomes (1)

• postoperative hearing

  hearing on pure tone audiometry according to AAO-HNS/Gardner-Robertson

  3 months (± 6 weeks) after surgery

Secondary Outcomes (2)

• postoperative facial nerve function

  up to 8 days after surgery

• postoperative facial nerve function

  3 months (± 6 weeks) after surgery

Other Outcomes (21)

• postoperative hearing

  up to 8 days after surgery

• laboratory findings

  within 4 hours after surgery

• laboratory findings

  within 4 hours after surgery

Study Arms (2)

RIC

EXPERIMENTAL

On the right upper extremity a blood pressure cuff is inflated to 200mmHg for 4x5min at the beginning of the surgery

Procedure: Remote ischemic preconditioning

Control

SHAM COMPARATOR

On the right upper extremity a blood pressure cuff is inflated to 0mmHg for 4x5min at the beginning of the surgery

Procedure: Sham-control

Interventions

Remote ischemic preconditioning PROCEDURE

A blood pressure cuff is inflated to 200 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started

RIC

Sham-control PROCEDURE

A blood pressure cuff is inflated to 0 mmHg for 4x5 min (5 min rest between cycles) at the right upper extremity when the vestibular schwannoma surgery is started

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Contantin Roder, Prof., MD

  Department of Neurosurgery Tuebingen

  PRINCIPAL INVESTIGATOR

• Helene V Hurth, MD

  Department of Neurosurgery Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene V Hurth, MD

CONTACT

+49 7071 29 80325; helene.hurth@med.uni-tuebingen.de

Constantin Roder, Prof., MD

CONTACT

constantin.roder@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: only the study nurse who performs the intervention is aware of the study arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: group 1: intervention, remote ischemic preconditioning for 4x5 minutes at the beginning of the surgery group 2: sham-control (4x5 min without compression of the extremity)

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 5, 2022
• Study Start: October 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: October 5, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)