The effects of anesthesia on motor evoked potentials

The effects of depth of anesthesia and blood pressure on motor evoked potentials in spinal surgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26470

Enrollment

Registered

2019-06-03

Start date

2019-04-11

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All patients undergoing spinal sugery with the use of TES-MEP will be eligible for inclusion in either part 1 or part 2 of this study.

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: - Patient should be = 16 years - Patient is diagnosed with spinal pathology for which surgery with the use of TES-MEP 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 or implantable cardioverter-defibrillator

Design outcomes

Primary

Measure	Time frame
Part 1: The primary outcome of part 1 are the TES-MEP amplitudes of the leg muscles, associated with different depths of anesthesia, defined by different pEEG values (30, 40 and 50). Part 2: The primary outcome of part 2 are the TES-MEP amplitudes of the leg muscles, associated with different blood pressures, while the MAP is elevated from 60 to 100 with a vasopressor infusion.	—

Secondary

Measure	Time frame
Part 1: effect of depth of anesthesia on motor evoked potentials Secondary objective 1: - Estimated propofol effect site concentration (Ce) - Measured propofol blood concentration - MAP Secondary objective 2: - Pre- and post-operative neurological outcome - Significant TES-MEP amplitude decreases and the associated MAP and pEEG values at the time of the significant decrease. Secondary objective 3: - SSEPs Part 2: effect of elevating blood pressure on motor evoked potentials Secondary objective 1: - Estimated propofol Ce - Measured propofol blood concentration - pEEG Secondary objective 2: - Pre- and post-operative neurological outcome - Significant TES-MEP amplitude decreases and the associated MAP and pEEG values at the time of the significant decrease. Secondary objective 3: - SSEPs Other study parameters Other modalities are measured in clinical practice and can be correlated with the clinical outcome. The modalities of interest consist of: - F-wave of the tibialis nerve - Hoffman’s reflex (H-reflex) of the tibialis nerve - D-waves - Raw-electroencephalogram (EEG) - Near Infrared Spectroscopy (NIRS)	—

Measure

Time frame

Part 1: effect of depth of anesthesia on motor evoked potentials Secondary objective 1: - Estimated propofol effect site concentration (Ce) - Measured propofol blood concentration - MAP Secondary objective 2: - Pre- and post-operative neurological outcome - Significant TES-MEP amplitude decreases and the associated MAP and pEEG values at the time of the significant decrease. Secondary objective 3: - SSEPs Part 2: effect of elevating blood pressure on motor evoked potentials Secondary objective 1: - Estimated propofol Ce - Measured propofol blood concentration - pEEG Secondary objective 2: - Pre- and post-operative neurological outcome - Significant TES-MEP amplitude decreases and the associated MAP and pEEG values at the time of the significant decrease. Secondary objective 3: - SSEPs Other study parameters Other modalities are measured in clinical practice and can be correlated with the clinical outcome. The modalities of interest consist of: - F-wave of the tibialis nerve - Hoffman’s reflex (H-reflex) of the tibialis nerve - D-waves - Raw-electroencephalogram (EEG) - Near Infrared Spectroscopy (NIRS)

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Contacts

Public ContactSebastiaan Dulfer

University of Groningen, University Medical Center Groningen

s.e.dulfer@umcg.nl+31503610522

Outcome results