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Completed

NCT Number: NCT02025309

Intraoperative Methylprednisolone and Sugammadex

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ankara University Faculty of Medicine, Ibni Sina Hospital OR

Ankara, 06700, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular monitorisation

Device

Other names: Train of Four

Primary outcomes

  1. Train of four ratio 0.9

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 1, 2014
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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