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Assessing the Impact of Desflurane versus Dexmedetomidine in Combination with Propofol Infusion on Transcranial Electrical Stimulation Motor Evoked Potential (Tc-MEP) in Spinal Surgery: double-blind randomized control trial

Assessing the Impact of Desflurane versus Dexmedetomidine in Combination with Propofol Infusion on Transcranial Electrical Stimulation Motor Evoked Potential (Tc-MEP) in Spinal Surgery: double-blind randomized control trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20250709002
Enrollment
58
Registered
2025-07-09
Start date
2024-05-02
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Spinal disease requiring spinal surgery with MEP monitoring complex spine, spinal surgery, MEP monitoring

Interventions

The patients aged 12 years old or higher undergoing any complex spine surgery that requires MEP monitoring will be given propofol TCI with desflurane at 0.3 MAC during the anesthesia maintenance perio
Screening,Screening
patients maintained with propofol infusion and desflurane,patients maintained with propofol and dexmedetomidine infusion

Sponsors

Faculty of Medicine, Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 90 Years

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

MeasureTime 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

MeasureTime 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

Public ContactManee Raksakiattisak

Faculty of Medicine, Siriraj Hospital, Mahidol University

manee95@hotmail.com66943081506

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026