An interventional study of Sugammadex and Saline in Sugammadex and Motor Evoked Potentials, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during surgery without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation.The feasibility of TcMEP interpretation was assessed during partial NMB in adult neurosurgical patients. However, partial NMB may interfere record of TcMEP monitoring. Sugammadex is the first highly selective antagonist that can reverse NMB. This study aims to evaluate the success rate of intraoperative muscle relax reversal by sugammadex on intraoperative TceMEP recording.
Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Sugammadex
Drug: Saline
The muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs.
The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later.
The success rate of TceMEPs
The success rate of Transcranial motor evoked potentials monitoring（TceMEPs）
Time frame: 5 minutes after first performing of TceMEPs
Mean value of amplitudes of TceMEPs
Mean value of amplitudes of Transcranial motor evoked potentials monitoring（TceMEPs）in the abductor pollicis brevis muscles of both upper extremities
Time frame: 5, 10, 20, 30 and 60 minutes after first performing of TceMEPs
Mean value of latencies of TceMEPs
Mean value of latencies of Transcranial motor evoked potentials monitoring（TceMEPs） in the abductor pollicis brevis muscles of both upper extremities
Time frame: 5, 10, 20, 30 and 60 minutes after first performing of TceMEPs.
Thresholds of TceMEPs
The thresholds that are required to obtain a dependable Transcranial motor evoked potentials monitoring（TceMEPs） response.
Time frame: 5 minutes after first performing of TceMEPs
respiratory pressure
Peak respiratory pressures
Time frame: during the surgery
Adverse effects of sugammadex
Adverse effects of sugammadex such as anaphylaxis (including flushing, oedema, tachycardia and bronchospasm), arrhythmias (heart rate lower than 60bpm), postprocedural pain, nausea and vomiting, fever (body temperature more than 37.3℃ ), and diarrhea, etc
Time frame: during the surgery
Incidence of body movement
Incidence of body movement classified as either nociception-induced movement (defined as "coughing" or reflexive limb movement temporally related to MEP stimulation) or excessive field movement (defined as grossly visible movement as determined by surgical and anaesthesia teams).
Time frame: during the surgery
Recurrence of neuromuscular blockade
Recurrence of neuromuscular blockade defined as TOFr \< 0.9
Time frame: time of extubation
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital