Intraoperative Methylprednisolone and Sugammadex

NCT02025309 | Completed Phase 4

• 1 other identifier: 16-627-13
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Monitoring; Sugammadex Effect

Keywords

train of four; neuromuscular recovery; sugammadex

Outcome Measures

Primary Outcomes (1)

• Train of four ratio 0.9

  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.

  During the procedure period.

Study Arms (2)

Group Methylprednisolone

ACTIVE COMPARATOR

Patient in this group received general anaesthesia for surgical procedures. During the anesthesia management methylprednisolone was administered intravenously (1mg/kg) to the patients in this group. Also neuromuscular monitorisation was performed to assess the train of four ratio at the end of the procedure, after the reversal of neuromuscular block. All patients were followed during the recovery period from general anaesthesia and the time needed to regain a full neuromuscular recovery was noted. For that, the train of four ratio was followed up and the ratio of 0.9 was recorded.

Device: Neuromuscular monitorisation

Group Control

PLACEBO COMPARATOR

Patients who received general anaesthesia and endothracheal entubation but who did not recieved methyprednisone during general anaesthesia were enrolled in the study as control group. Neuromuscular monitorisation was performed to assess the train of four ratio at the end of the procedure, after the reversal of neuromuscular block. All patients were followed during the recovery period from general anaesthesia and the time needed to regain a full neuromuscular recovery was noted. For that, the train of four ratio was followed up and the ratio of 0.9 was recorded.

Device: Neuromuscular monitorisation

Interventions

Neuromuscular monitorisation DEVICE

Also known as: Train of Four

Group Control; Group Methylprednisolone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient operated under general anesthesia and endothracheal intubation.
• years old
• ASA II

You may not qualify if:

• Neuromuscular desease
• Renal desease
• Liver failure
• Hypersensitivity to the medications used in the study.
• Being on steroid medication
• Pregnanacy, Lactation

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine, Ibni Sina Hospital OR

Ankara, 06700, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Neuromuscular Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Merve Hayriye Kocaoglu, MD

  Ankara University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DESA

Study Record Dates

• First Submitted: December 24, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

TU (1)