Spinal disease requiring spinal surgery with MEP monitoring complex spine, spinal surgery, MEP monitoring
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.ASA I-III 2.Preoperative muscle strength III-V (Manual muscle testing) 3.Cervico-thoracic-lumbar spine surgery requiring Tc-MEP monitoring
Exclusion criteria
Exclusion criteria: 1.Drug abuse 2.Intracranial hypertension syndrome 3.Diabetic peripheral neuropathy 4.Myasthenia gravis 5.Severe kidney dysfunction (Cr>3, GFR<30) 6.Severe circulatory respiratory system disease 7.Mental disorder 8.Pacemaker 9.Epilepsy 10.Skull defect 11.Hearing loss 12.Learning disorder 13.Language communication difficulties
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transcranial motor-evoked potential amplitude in six prespecified muscle-side recordings. T1, after pedicle screw insertion and rod placement; and Tfinal, before wound closure. T0, the first stable intraoperative recording after prone positioning and before incision Peak-to-peak compound muscle action potential amplitude in microvolts recorded bilaterally from the abductor pollicis brevis, abductor hallucis, and gastrocnemius | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative management and harms T0, T1, Tfinal anesthetic exposure, fluid and blood-product administration, vasopressor use, hypotensive monitor readings, study-adjunct discontinuation, emergency unblinding, and movement-related interruption,New postoperative motor deficit postanesthesia care unit, on postoperative day 1, daily thereafter, and before hospital discharge reduction from the preoperative manual muscle examination on the 0 to 5 Medical Research Council scale,Postoperative outcomes postoperative day 3; intensive care admission; hospital length of stay. pain scores, intravenous morphine-equivalent consumption, and postoperative nausea and vomiting,Recovery outcomes extubation period eye-opening time, extubation time, and time to orientation in minutes,Emergence agitation after awake extubation in the operating room and before transfer maximum Richmond Agitation-Sedation Scale score of +1 or higher,Movement during monitoring during surgery any gross body or trunk movement during transcranial motor-evoked potential acquisition, excluding expected localized evoked muscle responses,Successful establishment of stable bilateral T0 responses T0 presence of reproducible responses in two consecutive stimulations with consistent waveform morphology and amplitude in all six muscle-side recordings,Marked amplitude reduction T1, Tfinal strict reduction of more than 80 percent from T0 in each muscle and a participant-level composite of at least one affected muscle,Initial train-of-four ratio before protocolized neuromuscular-recovery management and neostigmine use before T0 T0 assessed after exposure to the allocated adjunct and before the waiting/reversal algorithm. | — |
Countries
Thailand
Contacts
Faculty of Medicine, Siriraj Hospital, Mahidol University