RecruitingPhase 4ACTRN12612000245897

Influence of glucocorticoids on sugammadex action

A randomized parallel group study of glucocorticoids influence on sugammadex efficacy in patients anesthetized for elective surgery


Sponsor

University Medical Center Ljubljana

Enrollment

60 participants

Start Date

Feb 2, 2012

Study Type

Interventional

Conditions

Summary

Muscle relaxation has a significant role in general anesthesia, indications for the use of muscle relaxants (MR) are endotraheal intubation, surgical procedures on thorax and abdomen and microscopic surgery where it is necessary for patients to be fully relaxed. There are depolarising (succynilcholine) and nondepolarising (benzylisoquinolines, aminosteroids) MR. The reversal of neuromuscular blockade (NMB) at the end of anesthesia has to be achieved either by conventional acetylcholinesterase inhibitors (AChE inhibitors) or with new reversal agent sugammadex which introduced completely new concept of NMB reversal.Sugammadex encapsulates aminosteroid MR and therefore reduces the circulating MR concentration which by concentration gradient removes MR molecules from neuromuscular junction (NMJ). Complex sugammadex-MR is excreted in urine within 1-4 hours. Sugammadex therefore provides more rapid reversal of even deeper or more intensive NMB compared to broadly used AChE inhibitors. It is a drug of choice in reversing NMB in patients with neuromuscular disease (e.g. miasthenia gravis) and in patients with heart or lung disease in whom use of AChE inhibitors in less desirable due to their unfavorable side effects. Glucocorticoids are widely used agents as part of patient's daily regimen as well as an antiemetic agent during anaesthesia. The similarity of molecular structure of glucocorticoid and aminosteroid MR rises concerns whether the concurrent use of glucocorticoid could affect the efficiency of sugammadex. In our prospective randomised study we will include 60 patients anesthetized for elective surgery (abdominal, thoracic). Patients enrolled into observational group will receive dexamethasone 0,15 mg/kg for prevention of postoperative nausea and vomiting (PONV), whereas patients in controlled group will receive granisetron 1 mg for the same purpose. Anesthesia will be conducted and maintained in standard fashion, muscle relaxation will be achieved using rocuronium, which will be added according to TOF (train of four) values. At the end of the operation we will draw the first sample of blood before application of sugammadex and the second one after regaining full muscle strength according to TOF. We will compare the blood levels of rocuronium (both groups) and dexamethasone (observational group) before and after sugammadex application which will allow us to indirectly evaluate possible dexamethasone encapsulation by sugammadex. The aim of our study is to asess whether concurrent use of dexamethasone affects the efficacy of sugammadex.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether the steroid medication dexamethasone, commonly given to prevent nausea and vomiting during surgery, can affect the performance of a muscle relaxant reversal drug called sugammadex. Sugammadex works by binding to and removing muscle relaxants used during general anaesthesia. Because dexamethasone and these muscle relaxants have a similar molecular structure, there is concern that sugammadex might accidentally bind to dexamethasone instead. Blood samples will be taken before and after sugammadex is given to check drug levels. You may be eligible if: - You are 18 years of age or older (up to 100 years) - You are scheduled for elective abdominal or chest surgery requiring general anaesthesia and full muscle relaxation - Your anaesthesia risk is classified as ASA I to III You may NOT be eligible if: - You have not consented to take part - You have a neuromuscular disease - You have a difficult airway expected - You have kidney failure - You or a family member has a history of malignant hyperthermia - You have an allergy to any anaesthetic agents used - You are pregnant or breastfeeding - You are taking oral contraceptives - You are taking drugs that may interact with sugammadex Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

We will clinically evaluate (using TOF values) residual neuromuscular blockade after reversal with sugammadex in patients intraoperatively receiving glucocorticoids (dexamethasone 0,15 mg/kg i.v. at t

We will clinically evaluate (using TOF values) residual neuromuscular blockade after reversal with sugammadex in patients intraoperatively receiving glucocorticoids (dexamethasone 0,15 mg/kg i.v. at the end of the operation) for PONV prevention in comparison to individuals, receiving standard treatment (granisetron 1 mg i.v. after induction) - control group. Concurrently we will withdraw a blood sample before and after application of sugammadex to measure rocuronium and dexamethasone (in observation group) blood level.


Locations(1)

Slovenia

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ACTRN12612000245897