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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex group | Experimental |
| |
| control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | The muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of TceMEPs | The success rate of Transcranial motor evoked potentials monitoring（TceMEPs） | 5 minutes after first performing of TceMEPs |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5, 10, 20, 30 and 60 minutes after first performing of TceMEPs |
| Mean value of latencies of TceMEPs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37626303 | Derived | Jian M, Liu H, Liang F, Ma B, Wang L, Zhou Y, Qiao H, Han R, Wang C. Effect of intraoperative muscle relaxation reversal on the success rate of motor evoked potential recording in patients undergoing spinal surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Aug 25;23(1):290. doi: 10.1186/s12871-023-02211-z. | |
| 35501072 |
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3 months after the study is finished
principal investigator
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Saline | Drug | The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later. |
|
Mean value of latencies of Transcranial motor evoked potentials monitoring（TceMEPs） in the abductor pollicis brevis muscles of both upper extremities |
| 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. | 5 minutes after first performing of TceMEPs |
| respiratory pressure | Peak respiratory pressures | 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 | 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). | during the surgery |
| Recurrence of neuromuscular blockade | Recurrence of neuromuscular blockade defined as TOFr < 0.9 | time of extubation |
| Jian M, Ma B, Liu H, Wang C, Liang F, Zhou Y, Qiao H, Han R. Effect of intraoperative muscle relaxation reversal on the success rate of motor-evoked potential recording in patients undergoing spinal surgery: study protocol for a randomised controlled trial. BMJ Open. 2022 May 2;12(5):e056571. doi: 10.1136/bmjopen-2021-056571. |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |