The Usefulness of Multimodal Intraoperative Neurophysiologic Monitoring During Brain or Spine Surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- rate of occurrence of New Postoperative Neurological Deficits
Study Overview
Brief Summary
Objective: This study aimed to integrate findings from spinal and cranial surgeries with existing literature, emphasizing the role of Intraoperative Neurophysiological Monitoring (IONM) in improving surgical outcomes through best practices.
Methodology: Multimodal IONM, including motor evoked potential (MEP), somatosensory evoked potential (SSEP), and electromyography (EMG), was utilized in surgeries at Duke University Hospitals. Challenges included a small sample size and limited access to medical records.
Findings:
Effectiveness of IONM: High sensitivity (97.73%), specificity (83.33%), and predictive value of multimodal IONM confirmed its role in detecting intraoperative neurological injuries and optimizing outcomes.
Demographics: Analysis of 50 cases (58% male, aged 13-67 years) revealed demographic influences on surgical challenges and outcomes.
IONM Alerts: A 50% reduction in MEP/SSEP amplitudes was a critical criterion, with reversible alerts accounting for 70%, emphasizing the dynamic nature of neural responses.
Alert Causes & Management: Excessive dissection was a common cause of alerts. Interventions like warm saline irrigation and surgical pauses mitigated risks.
Outcome Associations: Most patients (88%) experienced no new postoperative deficits, with significant associations between alert reversibility and deficit occurrence.
Statistical Insights:
Predictive Value: Strong correlations were observed between alert patterns and postoperative outcomes, with SSEP/MEP alerts reliably predicting neurological deficits.
Technology & Resources: Modern devices, updated technology, and skilled staff were critical for high-quality results, highlighting the adage that "poor monitoring is worse than no monitoring."
Contextual Observations:
Heterogeneity of Cases: Diagnoses ranged from cervical intramedullary tumors to lumbar canal stenosis, requiring tailored interventions.
EMG Utility: EMG showed stability with fewer alerts, proving beneficial in specific surgeries.
Corrective Measures: Adjustments in mean arterial blood pressure and steroid use showcased adaptive intraoperative strategies.
Protocol Gaps: The absence of standardized IONM alert response protocols was noted, underscoring the need for future research.
Detailed Description
Detailed Description:
The discussion emphasizes the importance of intraoperative neurophysiological monitoring (IONM) in enhancing surgical safety during spinal and cranial procedures. Multimodal IONM (MIONM), incorporating somatosensory evoked potentials (SSEP), motor evoked potentials (MEP), and electromyography (EMG), serves as a critical tool for real-time neurological monitoring during these complex operations.
MIONM is highlighted for its ability to detect intraoperative neurological changes, enabling timely interventions. Factors such as patient demographics and case heterogeneity, including diverse diagnoses like craniotomy, lumbar canal stenosis, scoliosis, and cervical intramedullary tumors, underscore the need for tailored surgical approaches. The integration of modern equipment and experienced personnel ensures the delivery of high-quality monitoring results.
The discussion also explores the challenges in managing IONM alerts, including causes like over-dissection, hypoperfusion, and excessive cord manipulation. A multimodal approach to handling alerts includes interventions such as positional adjustments, warm saline irrigation, and optimizing blood flow. The absence of standardized protocols for responding to alerts highlights the need for future research to develop evidence-based guidelines.
Further research is encouraged to refine IONM methodologies, customize surgical strategies based on patient-specific factors, and establish standardized alert response protocols to optimize outcomes in spinal and cranial surgeries.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 12 years.
- •Various brain or spinal pathologies that are indicated for (IONM) such as (cerebellopontine angle tumors, scoliosis, epidural abscesses, arteriovenous malformations, canal stenosis, tumor resection, and craniotomies.
- •Medically fit for surgery.
Exclusion Criteria
- •Unobtainable or poor baselines (both MEPs and SSEPs).
- •Patients with a motor power grade of 1 or below.
- •Presence of vascular clips, intracranial electrodes, pacemakers, other implanted biomechanical equipment, cortical lesions, skull defects, increased intracranial pressure, and history of epilepsy.
Arms & Interventions
Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) Arm
This arm involves the application of Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) during neurosurgical procedures. Participants in this arm undergo continuous intraoperative monitoring using a combination of:
Somatosensory Evoked Potentials (SSEP): Monitoring sensory pathway integrity. Motor Evoked Potentials (MEP): Assessing motor pathway functionality. Electromyography (EMG): Detecting nerve irritation and monitoring cranial and limb muscles.
The intervention is designed to enhance surgical precision by providing real-time feedback to the surgical team, aiming to prevent postoperative neurological deficits and improve patient outcomes. Pre- and postoperative clinical assessments are conducted to evaluate the effectiveness of MIONM.
Intervention: Multimodal Intraoperative Neurophysiologic Monitoring (MIONM) (Device)
Outcomes
Primary Outcomes
rate of occurrence of New Postoperative Neurological Deficits
Time Frame: Evaluated within one-week post-surgery.
The primary outcome is the proportion of patients who develop new neurological deficits (motor, sensory, or combined) after undergoing neurosurgical procedures with Multimodal Intraoperative Neurophysiologic Monitoring (MIONM). These deficits will be assessed through detailed clinical examinations pre- and post-surgery.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed El Sakka
assistant lecturer of PMR
Alexandria University