Motor Evoked Potentials, Sugammadex
Conditions
Brief summary
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.
Interventions
DRUGSugammadex
The muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs.
DRUGSaline
The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age range from 18 to 65 years old * American Society of Anesthesiologists (ASA) physical status I to II
Exclusion criteria
* BMI ≥35 kg/m-2 * History of epilepsy or use of antiepileptic drugs * Personal history or family history of malignant hyperthermia * Allergies to sugammadex; NMBs or other medication(s) used during general anesthesia * Hemoglobin \<110 g/L * TceMEP stimulation or recorded site infection * Preoperative neurological dysfunction in both upper extremities * Cardiac pacemaker * Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success rate of TceMEPs | 5 minutes after first performing of TceMEPs | The success rate of Transcranial motor evoked potentials monitoring（TceMEPs） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean value of amplitudes of TceMEPs | 5, 10, 20, 30 and 60 minutes after first performing of TceMEPs | Mean value of amplitudes of Transcranial motor evoked potentials monitoring（TceMEPs）in the abductor pollicis brevis muscles of both upper extremities |
| Mean value of latencies of TceMEPs | 5, 10, 20, 30 and 60 minutes after first performing of TceMEPs. | Mean value of latencies of Transcranial motor evoked potentials monitoring（TceMEPs） in the abductor pollicis brevis muscles of both upper extremities |
| Thresholds of TceMEPs | 5 minutes after first performing of TceMEPs | The thresholds that are required to obtain a dependable Transcranial motor evoked potentials monitoring（TceMEPs） response. |
| Recurrence of neuromuscular blockade | time of extubation | Recurrence of neuromuscular blockade defined as TOFr \< 0.9 |
| Adverse effects of sugammadex | during the surgery | 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 |
| Incidence of body movement | during the surgery | 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). |
| respiratory pressure | during the surgery | Peak respiratory pressures |
Countries
China
Outcome results
None listed