RecruitingACTRN12612000087853

Anaesthesia practice since introduction of sugammadex: has it changed patient outcome?

Patient outcome after reversal of residual neuromuscular blockade with either neostigmine or no reversal agent vs. reversal with sugammadex.


Sponsor

Thomas Ledowski

Enrollment

1,600 participants

Start Date

Feb 1, 2011

Study Type

Observational

Conditions

Summary

The drug sugammadex (Bridion) has recently been introduced into clinical practice at the Royal Perth Hospital (RPH). This drug provides the anaesthetist with a new and very efficient way of reversing the effects of amino-steroidal neuromuscular blocking agents. If not completely reversed, the residual effects of muscle relaxants are known to significantly impair postoperative patient outcome (Murphy et al. , Anesthesia and Analgesia 2010; 111: 120-8). Unfortunately, when muscle relaxants are either not reversed or neostigmine is used, the incidence of such residual paralysis is extremely high (50-60% at RPH 2011, own pilot data)! This is at least partially due to a lack of appropriate monitors (already highlighted this matter to hospital and monitors are being bought) but also the lack of a reliable muscle relaxant antagonist. The latter may have changed since introduction of sugammadex in Australia in 2010. In a just completed audit we found strong evidence for a potential of sugammadex to result in better postoperative outcomes (lower incidence of residual neuromuscular blockade and lower incidence of postoperative pneumonia/atelectasis). However, the numbers investigated were too low to draw final conclusions. Based on this pilot data we will need to investigate at least 721 cases with the use of sugammadex and compare them with at least 721 control cases in whom no or a different reversal drug (neostigmine) has been used. This equals the investigation of data from patients intubated at RPH over approx. 12 months. The goal of this retrospective study is to build on our previous audit and investigate whether the use of sugammadex indeed resulted in beneficial patient outcomes over the last 12 months. For this purpose, the data review will identify all eligible patients who received neuromuscular blocking agents and the mode of its reversal at the end of surgery. Main outcome data are adverse events in the recovery room, within 30 days after surgery (lung associated complications) and length of stay (recovery/hospital).


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at whether the introduction of a drug called sugammadex (Bridion) has improved outcomes for patients having surgery under general anaesthesia at Royal Perth Hospital. Sugammadex is a fast and reliable way to reverse the muscle-relaxing drugs used during surgery. Without complete reversal, patients can experience residual muscle weakness after the operation, which can lead to breathing complications. This is a retrospective study — researchers review medical records of patients who have already had surgery. You may be eligible if: - You are 16 to 100 years old - You had surgery at Royal Perth Hospital requiring general anaesthesia with a breathing tube and muscle relaxant drugs You may NOT be eligible if: - You had major trauma surgery or cardiothoracic (heart/lung) surgery - You arrived at or left the operating theatre already on a breathing tube 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

This is an observational trial. We aim to retrospectively investigate outcome parameters (incidence of pulmonary complications postoperatively, length of stay in the recovery room/the hospital) and i

This is an observational trial. We aim to retrospectively investigate outcome parameters (incidence of pulmonary complications postoperatively, length of stay in the recovery room/the hospital) and incidence of adverse airway events in the recovery room) in postoperative patients who received reversal of neuromuscular paralysis with either neostigmine or no reversal agent or sugammadex. Data will be collected from patients' medical records, an electronic theatre management system (e.g. anaesthesia times, length of stay) and an electronic medical results system (ISOFT; e.g. white cell count and chest-xray reports). Data collection will include patients whose surgery took place from 1.3.11 until present. Data collection will include consecutive patients until the sample size per group has been achieved.


Locations(1)

Australia

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ACTRN12612000087853