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Intraoperative Methylprednisolone and Sugammadex

NCT02025309 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2018-08-07

No results posted yet for this study

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

DEVICE

Neuromuscular monitorisation

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Principal Investigators

  • Merve Hayriye Kocaoglu, MD · Ankara University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025309 on ClinicalTrials.gov