Sugammadex
Conditions
Brief summary
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. However, full blockade offers increased anesthetic management options and facilitates surgery. Here, investigators want to assess the effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.
Interventions
DRUGSugammadex
Sugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four ≥2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP
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
* 18-65 years * ASA status I-II * Patients undergo thoracic or lumbar spinal surgery * tcMEP monitoring during the surgery * Informed consent signed by patients
Exclusion criteria
* BMI ≥35 Kg/m-2 * history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s) * history or family history of malignant hyperthermia * allergies to sugammadex, NMBs or other medication(s) used during general anesthesia * anemia, hemoglobin \<110g/L, * TcMEPs stimulate or record site infection * preoperative neurological dysfunction in both upper extremities * cardiac pacemaker * pregnancy and breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The amplitude of MEP | 5 minutes after dura opening | mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The latencies of MEPs | 5, 10, 20, 30 and 60 minutes after dura opening. | Mean value of latencies of TceMEPs in abductor pollicis brevis muscles of both upper extremities |
| Respiratory parameters | during the surgery | Peak respiratory pressures and incidence of peak insufflation pressure of more than 25cmH2O. |
| Adverse effects of sugammadex | during and 24 hours after the surgery | Anaphylaxis, arrhythmias, post-procedure pain, nausea and vomiting, fever and diarrhea, etc. |
| The amplitude of MEP | 10, 20, 30 and 60 minutes after dura opening | Mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities 10, 20, 30 and 60 minutes after dura opening. |
| Recurrence of neuromuscular blockade | At the end of surgery | Recurrence of neuromuscular blockade at the end of surgery. |
| Motor function assessment | 5 days after surgery | SMP-a scale |
| Total bleeding volume | during the surgery | Total bleeding volume during the surgery |
| Incidence of body movement | during the surgery | 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 anesthesia teams). |
Countries
China
Outcome results
None listed