NCT02025309

Intraoperative Methylprednisolone and Sugammadex

Does Intraoperatively Administered Methylprednisolone Prolong the Neuromuscular Blocade Reversal Effect of Sugammadex?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuromuscular Monitoring
• Sugammadex Effect

Interventions

Type	Name	Description
DEVICE	Neuromuscular monitorisation

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-01-01
• Last updated: 2018-08-07

Locations

1 site across 1 country: Turkey (Türkiye)