Neuromuscular Monitoring, Sugammadex Effect
Conditions
Keywords
train of four, neuromuscular recovery, sugammadex
Brief summary
Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its activity by encapsulating these. Likewise, some other steroid hormones and drugs like flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in this study we aimed to compare the recovery times from recuronium-induced muscle relaxation after reversal with sugammadex between patients who receive intraoperative methylprednisolone or not. After institutional review board (IRB) approval and informed consent, 100 patients will be enrolled in this prospective, single center, controlled study. Anaesthesia will be induced with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance. Patients will be divided randomly into two groups methylprednisolone administered group and control group respectively). Neuromuscular blockade will be monitored using calibrated acceleromyography train-of-four (TOF WATCH SX Organon Ltd, Dublin, Ireland). Once rocuronium-induced neuromuscular blockade recovers spontaneously to TOF-count-two, all patients will receive 2.0 mg/kg of sugammadex. Neuromuscular monitoring will be continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time to recovery of TOF to 0.9 will be compared in both groups. The statistical analyses will be performed using Student T Test and Mann-Whitney U test.
Interventions
DEVICENeuromuscular monitorisation
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patient operated under general anesthesia and endothracheal intubation. * 18-65 years old * ASA II
Exclusion criteria
* Neuromuscular desease * Renal desease * Liver failure * Hypersensitivity to the medications used in the study. * Being on steroid medication * Pregnanacy, Lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Train of four ratio 0.9 | During the procedure period. | At the end of the procedure, train of four (TOF) monitorisation was continued and once rocuronium-induced neuromuscular blockade recovered spontaneously to TOF-count-two, all patients received 2.0 mg/kg of sugammadex. Then, neuromuscular monitoring was continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time needed for the recovery of TOF to 0.9 was noted. |
Countries
Turkey (Türkiye)
Outcome results
None listed