Intraoperative Methylprednisolone and Sugammadex

Ankara University

Status and phase: Completed; Phase 4

Conditions: Neuromuscular Monitoring; Sugammadex Effect

Treatments: Device: Neuromuscular monitorisation

Study type: Interventional

Funder types: Other

Identifiers

NCT02025309

16-627-13

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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164 participants in 2 patient groups, including a placebo group

Group Methylprednisolone

Active Comparator group

Description:

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.

Treatment:

Device: Neuromuscular monitorisation

Group Control

Placebo Comparator group

Description:

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.

Treatment:

Device: Neuromuscular monitorisation