Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial.

BACKGROUND: Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications. METHODS: Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital). RESULTS: Among 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5-4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67). CONCLUSIONS: A large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible. TRIAL REGISTRATION: Prospectively registered at the Australian and New Zealand Clinical Trials Registry ( ACTRN12620001313921 ) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true .

COVID-19 risk in elective surgery during a second wave: a prospective cohort study.

BACKGROUND: The COVID-19 pandemic has greatly affected access to elective surgery, largely because of concerns for patients and healthcare workers. A return to normal surgery workflow depends on the prevalence and transmission of coronavirus in elective surgical patients. The aim of this study was to determine the prevalence of active SARS-coronavirus-2 infection during a second wave among patients admitted to hospital for elective surgery in Victoria. METHODS: Prospective cohort study across eight hospitals in Victoria during July-August 2020 was conducted enrolling adults and children admitted to hospital for elective surgery or interventional procedure requiring general anaesthesia. Study outcomes included a positive polymerase chain reaction (PCR) test for SARS-CoV-2 in the preoperative period (primary outcome), and for those with a negative test preoperatively, the incidence of a positive PCR test for SARS-CoV-2 in the post-operative period. RESULTS: We enrolled 4965 elective adult and paediatric surgical patients from 15 July to 31 August 2020. Four patients screened negative on questionnaire but had a positive PCR test for coronavirus, resulting in a Bayesian estimated prevalence of 0.12% (95% probability interval 0-0.26%). There were no reports of healthcare worker infections linked to elective surgery during and up to 2 weeks after the study period. CONCLUSION: The prevalence of SARS-CoV-2 in asymptomatic elective surgical patients during a second wave was approximately 1 in 833. Given the very low likelihood of coronavirus transmission, and with existing current hospital capacity, recommencement of elective surgery should be considered. A coronavirus screening checklist should be mandated for surgical patients.

Documenting COVID-19 screening before surgery during lockdown (COVID Screen): an audit with routinely collected health data.

Objective This study analysed screening for COVID-19 before surgery and outcomes of any perioperative testing for SARS-CoV-2 infection during pandemic-restricted surgery. Methods An audit was conducted with routinely collected health data before both elective and non-elective surgery at two large Melbourne hospitals during April and early May 2020. We looked for documented systematic screening for COVID-19 disease and fever (>38°C) and results of SARS-COV-2 testing, and proposed a minimum acceptable documenting rate of 85%. Results The study included 2197 consecutive patients (1279 (58%) undergoing elective surgery, 917 (42%) undergoing non-elective surgery) across most specialities. Although 926 (72%) patients undergoing elective surgery had both systematic screening and temperature documented, approximately half that percentage undergoing non-elective surgery (n=347; 38%) had both documented. However, 871 (95%) of non-elective surgery patients had temperature documented. Acknowledging limited screening, 85 (9.3%) non-elective surgery patients had positive screening, compared with 39 (3.0%) elective surgery patients. All 152 (7%) patients who were tested for SARS-CoV-2 were negative, and no cases were reported from external contact tracing. Conclusions Although 'not documented' does not necessarily equal 'not done', we found that documenting of COVID-19 screening could be improved. Better understanding of implementing screening practices in pandemics and other crises, particularly for non-elective surgery patients, is warranted. What is known about the topic? Little is known about routine screening for SARS-CoV-2 infection among surgical patients. However, it is well established that implementing effective uptake of safety and quality initiatives can be difficult. What does this paper add? We found that although most patients had documented temperature, fewer than 75% had a documented systematic questionnaire screen for COVID, particularly patients undergoing non-elective surgery. What are the implications for practitioners? Clear documenting is important in managing patients. Pandemics and other crises can require rapid changes in practice. Implementing such measures may be less complete than anticipated and may require greater use of evidence-based implementation strategies, particularly in the less predictable care of non-elective surgery patients.