disease of the spinal colomn spinal pathology for which spinal surgery is indicated
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: All >= 12 years Patient is diagnosed with spinal pathology for which surgery with the use of intraoperative neurophysiological monitoring has been planned Signed and dated informed consent document prior to any study-related procedures
Exclusion criteria
Exclusion criteria: Patient refusal Existing motor weakness in the tibialis anterior muscle left or right, the gastrocnemius muscle left or right and the abductor hallucis muscle left or right. Patients with epilepsy Patients with a pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: The main study parameter of part 1 is to investigate the effect of depth of anaesthesia, defined by different pEEG values (30, 40 and 50), on Tc-MEP voltage thresholds, Tc-MEP amplitude and Tc-MEP AUC of the leg muscles. Part 2: The main study parameter of part 2 is to investigate the effect of elevating MAP from 60 to 100 with a vasopressor infusion, on Tc-MEP voltage thresholds, Tc-MEP amplitude and Tc-MEP AUC of the leg muscles. * | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Secondary Objective 1: To determine if a combination of pEEG and propofol concentration (estimated effect-site concentration, or measured plasma concentrations) and/or actual MAP during Tc-MEP registrations, better enable prediction of Tc-MEP characteristics than pEEG alone. Hypothesis: a. pEEG values alone enable better prediction of Tc-MEP characteristics than propofol concentrations alone. b. pEEG alone is as good as a more complex model involving pEEG, propofol concentrations and MAP, at enabling prediction of Tc-MEP characteristics. Secondary objective 2: a. To formally quantify the incidence and severity of neurological deficits among the patients included in the study. b. Assuming sufficient numbers of patients with postoperative neurological deficits, a secondary objective will be to determine the sensitivity and specificity of different thresholds of changes in Tc-MEP amplitudes for prediction of outcome. c. Assuming sufficient numbers of patients with postoperative neurological deficits, a further secondary objective will be to determine the influence of pEEG and MAP values on the sensitivity and specificity of decreased Tc-MEP amplitude for prediction of outcome. The specific research question is whether reduced Tc-MEP amplitudes are more predictive of adverse outcome when pEEG and MAP are within the currently defined optimal ranges (pEEG 40 - 60, and MAP 70 - 90 mmHg). Hypothesis: Higher pEEG and MAP values result in a higher proportion of post-operative worsened neurological outcome after a significant Tc-MEP amplitude decrease. Secondary objective 3: To determine the effects of depth of anaesthesia, as quantified by pEEG, on the characteristics of SSEPs. Hypothesis: lower depth of anaesthesia, defined by higher values of the pEEG will not affect SSEP amplitude and/or latency. Part 2: Secondary Objective 1: To determine if a combination of MAP, with pEEG and/or propofol concentration (estimated effect-site con | — |
Countries
Netherlands
Outcome results
None listed