Browsing by Author "Biccard, Bruce"

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    A prospective study of paediatric preoperative fasting times at Red Cross War Memorial Children's Hospital
    (2021) Kouvarellis, Alison; Wilson, Graeme; Biccard, Bruce; van der Spuy, Karen
    Background. Fasting for liquids and solids is recommended prior to procedures requiring anaesthesia, to reduce the risk of pulmonary aspiration. Children often experience excessive fasting, which is associated with negative physiological and behavioural consequences, and patient discomfort. The duration of preoperative fasting in children in South Africa is unknown. Objectives. The aim of this study was to determine the compliance with fasting guidelines and fasting times of children prior to elective procedures performed under anaesthesia at a paediatric hospital in Cape Town, South Africa. The primary focus was fasting for clear liquid. The study also intended to identify the most common reasons for prolonged clear liquid fasting. Methods. Over a seven-week period, we prospectively captured fasting times of consecutive patients undergoing elective surgical, medical and radiological procedures at Red Cross War Memorial Children's Hospital (RCWMCH). Measurement outcomes were defined as the period from the last clear liquid, milk or solid feed to the start of anaesthesia. For analysis of compliance with preoperative fasting guidelines, institutional preoperative fasting target limits were established based on the standard 6-4-2 hour guideline. Results. The study included 721 elective paediatric cases. The mean (SD) fasting time for clear liquids (n=585) was 8.0 (4.8) hours, with an adherence rate of 25.5% (95% confidence interval (CI) 22-29%) to the institutional target of 2 to 4 hours. The mean (SD) fasting times for breast milk (n=92), formula milk (n=116) and solid feeds (n=560) were 7.1 (2.8), 8.8 (2.8) and 13.9 (3.6) hours respectively. The factors associated with clear liquid fasting >4 hours were: inadequate fasting instructions, poor adherence to fasting orders, procedural delays and fasting to promote theatre flexibility. Conclusion. This study demonstrates that children in a South Africa hospital experience excessive fasting times prior to elective procedures. To reduce fasting durations and improve the quality of perioperative care, quality improvement (QI) interventions are required to create an adaptable fasting system which allows individualised fasting. Improving preoperative fasting times in children is the responsibility of all health care professionals in the multi-disciplinary management team.
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    A quality improvement project evaluating the perioperative implementation of a hypertension management protocol by anaesthesiologists at seven government hospitals in the Western Cape. “a multi-center, cross-sectional quality improvement project: the peri-operative implementation of a hypertension protocol by anesthesiologists”
    (2021) Pfister, Claire-Louise; Biccard, Bruce; Dyer, Robert A; Rayner, Brian
    BACKGROUND: Hypertension is a common risk factor for cardiovascular morbidity and mortality, with a high prevalence in patients presenting for elective surgery. In limited resource environments, patients have poor access to primary care physicians, limiting the efficacy of life-style modification for the initial management of hypertension in the community. In these circumstances, the perioperative period presents a unique opportunity for diagnosis and initiation and/or modification of pharmacotherapy of hypertension. Anesthesiologists are ideally placed to lead this aspect of perioperative medicine. METHODS: In collaboration with expert physicians, we designed and implemented an algorithm for the diagnosis of hypertension and subsequent initiation or modification of anti-hypertensive therapy, or referral to a physician. The study was a multi-center, cross-sectional quality improvement project in seven hospitals in the Western Cape, South Africa. On the day before scheduled elective surgery, adult inpatients had two sets of blood pressure (BP) readings taken, one by nurses and the other by anesthesiologists, using a noninvasive automated blood pressure device. These were averaged on an electronic database, to diagnose hypertension. Patients with normal BP or well-controlled hypertension required no further management. Those with borderline BP received educational pamphlets. Patients with stage 1 or 2 hypertension were managed with medication according to the algorithm, starting 1 day postoperatively, and provided with educational pamphlets. Patients with stage 3 disease were referred to a physician. The primary outcome was adherence by the anesthesiologist to the algorithm, defined as initiation of the prescribed medication. An 80% adherence rate was considered successful implementation. The secondary outcome was the issue of the antihypertensive medication at discharge. RESULTS: Two hundred and ninety-eight patients were screened for hypertension. One hundred and six patients were eligible for the quality improvement project. Thirty-seven (34.9%) had borderline blood pressure readings, 43 (40.6%) had stage 1-, 22 (20.8%) stage 2-, and 4 (3.8%) stage 3 hypertension respectively. The adherence rate by the anesthesiologist was 84.0% (95% confidence interval (CI) 77.0% to 91.0%) for initiation of anti-hypertensive therapy. It was noted that 55.5% (95% CI 46.2% to 65.1%) received their medication upon discharge. CONCLUSIONS: Anesthesiologists successfully implemented a quality improvement project for diagnosis and management of hypertension in the perioperative period. This has the potential to reduce the public health burden of hypertension in limited resource environments. Successful ongoing prescription and follow-up requires cooperation within a multi-disciplinary team involving anesthesiologists, surgeons, nurses, pharmacists and physicians.
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    A study of the prevalence of preoperative anaemia and iron deficiency in adult elective surgical patients in hospitals in the western cape province, South Africa. “A multicentre prospective observational study of the prevalence of preoperative anaemia and iron deficiency in adult elective surgical patients in hospitals in western cape province, South Africa.”
    (2021) Conradie, Willem Stephanus; Roodt, Francois; Biccard, Bruce; Nejthardt, Marcin
    Background. Preoperative anaemia has been shown to be an independent risk factor for postoperative morbidity and mortality. Iron deficiency is the leading cause of anaemia globally. There are limited data describing the burden of perioperative anaemia and the relative contribution of iron deficiency in South Africa (SA). Objectives. To determine the prevalence and severity of preoperative anaemia in adults presenting for elective surgery in Western Cape Province, SA, and to investigate the contribution of iron deficiency as a cause of the anaemia. For this purpose, an investigative protocol from a recent consensus statement on the management of perioperative anaemia was applied. Methods. We performed a prospective, observational study in adult patients presenting for elective non-cardiac, non-obstetric surgery over a 5-day period at six Western Cape government-funded hospitals. The World Health Organization patient classification was applied, and patients with anaemia were investigated for iron deficiency. Results. The prevalence of preoperative anaemia was 28% (105/375; 95% confidence interval (CI) 23.5 - 32.5); 55/105 patients (52%) had moderate and 11/105 (11%) severe anaemia. Iron deficiency was the cause of anaemia in 37% (32/87; 95% CI 26.6 - 46.9), but only 9% of irondeficient patients received iron supplementation prior to surgery. Conclusions. Preoperative anaemia was common in this study, and more than half of the affected patients had moderate to severe anaemia. Iron deficiency was responsible for almost 40% of cases. Iron supplementation was under-utilised in the preoperative period as a means of increasing haemoglobin. The introduction of system-wide policies would empower perioperative physicians to mitigate the risk associated with preoperative anaemia in the Western Cape.
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    A systematic review of outcomes associated with withholding or continuing angiotensinconverting enzyme inhibitors (ACE-I) and angiotensin receptor blockers (ARB) prior to noncardiac surgery
    (2019) Hollmann, Caryl; Biccard, Bruce
    Introduction The global rate of major noncardiac surgical procedures is increasing annually, and of those patients presenting for surgery increasing numbers are taking either an angiotensin-converting enzyme inhibitor (ACE-I) or an angiotensin receptor blocker(ARB). The current recommendations whether to continue or withhold ACE-I and ARB in the perioperative period are conflicting. Previous metaanalyses have linked preoperative ACE-I /ARB therapy to the increased incidence of post induction hypotension, however have failed to correlate this with adverse patient outcomes. The aim of this meta-analysis was to determine whether continuation or withholding ACE-I or ARB therapy in the perioperative period is associated with mortality and major morbidity. Methods This meta-analysis was prospectively registered on PROSPERO (CRD42017055291). A comprehensive search of MEDLINE (PubMed), CINAHL (EBSCO host), ProQuest, Cochrane database, Scopus and Web of Science was conducted on 06 December 2016. We included adult patients >18years, on chronic ACE-I or ARB therapy who underwent noncardiac surgery, where ACE-I or ARB was either withheld or continued on the morning of surgery. Primary outcomes included all-cause mortality and major cardiac events (MACE). Secondary outcomes included the risk of congestive heart failure (CHF), acute kidney injury, stroke, intra/postoperative hypotension and the length of hospital stay (LOS). Results Following abstract review, the full text of 25 studies were retrieved, of which nine fulfilled the inclusion criteria; five were randomized control trials (RCTs) and four cohort studies. These studies included a total of 6022 patients on chronic ACE-I/ARB therapy prior to noncardiac surgery. 1816 patients withheld treatment the morning of surgery and 4206 continued their ACE-I/ARB. Preoperative demographics were similar between the two groups. Withholding ACE-I/ARB therapy was not associated with a difference in mortality (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.62-1.52; I2 =0%) or MACE (OR 1.12; 95% CI 0.82-1.52; I2 =0%). Withholding therapy was however associated with significantly less intra-operative hypotension (OR 0.63 95% CI 0.47;0.85, I 2 =71%). No effect estimate could be pooled concerning length of hospital stay and CHF. Conclusions This meta-analysis did not demonstrate an association between perioperative administration of ACEI/ARB, and mortality or MACE. It did however confirm the current observation that perioperative continuation of ACE-I/ARBs is associated with an increased incidence of intra-operative hypotension. A large randomized control trial is necessary to determine the appropriate perioperative management of ACE-I and ARBs.
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    An audit of the prevalence of abnormal fasting blood glucose levels in patients presenting for elective surgery at a selection of Western Cape government hospitals
    (2019) Biesman-Simons, Tessa; Nejthardt, Marcin; Biccard, Bruce; Roodt, Francois
    Background. Diabetes mellitus (DM) is a common condition. The high burden of undiagnosed DM and lack of large population studies make accurate prevalence estimations difficult, especially in the surgical environment. Furthermore, poorly controlled DM is associated with an increased risk of perioperative complications and mortality. Objectives. The primary objective was to establish the prevalence of DM in elective adult non-cardiac, non-obstetric surgical patients in Western Cape hospitals. The secondary objectives were to assess the glycaemic control and compliance with treatment of known diabetics. Methods. This was a five-day, multicentre, prospective observational study performed at six government-funded hospitals in the Western Cape. Screening for DM was done using fingerprick capillary blood glucose (CBG) testing. Patients found to have a CBG of ≥ 6.5 mmol/L had an HbA1c level done. DM was diagnosed based on the Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA) diagnostic criteria. Patients known with DM had an HbA1c performed and Morisky Medication Adherence Scale (MMAS-4) questionnaires completed, to assess glycaemic control and compliance with treatment. Results. Of the 379 participants, 61 were known diabetics (16.15%; 95% CI 12.4-19.8%). After exclusion of eight patients with incomplete results, a new diagnosis of DM was made in five out of 310 patients (1.6%; 95% CI 0.2-3.0%). Overall prevalence of DM was 17.8% (66/371; 95% CI 13.9-21.7%). HbA1c results were available in 57 (93.4%) of the 61 known diabetics. Of these 27 (47.4%; 95% CI 34.4-60.3%) had an HbA1c level≥8.5% and 14 (24.6%; 95% CI 13.4 - 35.8%) had an HbA1c ≤7%. Based on positive responses to two or more questions on their MMAS-4 questionnaires, 12 out of 60 participants (20%) were deemed non-compliant. Conclusion. There is a low rate of undiagnosed DM in our elective surgical population; however there is a large proportion of poorly controlled DM. Since poorly controlled DM is known to increase postoperative complications, this likely increases the burden of perioperative care. Resources should be focused on improvement of long-term glycaemic control in patients presenting for elective surgery.
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    Indications, challenges, and characteristics of successful implementation of perioperative registries in low resource settings: A systematic review
    (2022) Belachew, Fitsum Kifle; Biccard, Bruce
    Background Data is central to healthcare system improvement. Perioperative registries can be utilised for quality improvement initiatives through tracking outcomes, developing risk prediction models, and supporting policymakers and health professionals in making evidence-based decisions and interventions. This is particularly desirable in low-resource settings, where there is an unmet surgical demand and patients have a mortality rate up to double that of high-income countries. To better understand and support initiatives to establish clinical registries, this study aimed to assess the indications, challenges, and characteristics of successful perioperative registries in low-resource settings from the available literature on perioperative registry implementations. Materials and Methods We conducted a librarian-assisted literature search of international research databases; PubMed, Scopus, Cochrane Library, Web of Science, and WHOLIS WHO Library Database of articles published between January 1969 to January 2021 using controlled subject headings and keywords. Studies were filtered using predefined criteria and responses to two Mixed Method Appraisal Tool screening questions. A Direct Content Analysis Method was used to synthesize data for eligible studies based on predefined criteria. Results The search identified 2793 abstracts, with ten studies included after removing duplicates and excluding studies that did not meet eligibility criteria. Three were conducted in South America, four in Africa, two in the Middle East, and one in Asia. The lack of context-specific data for determining and evaluating patient outcomes (n=7) was the major indication for implementing registries. Organizing local research teams and engaging stakeholders in the host country was associated with successful implementation. However, inadequate funding to hire data collectors and monitor data quality was identified as a major challenge (n=4). Conclusion The goal of a perioperative registry is to generate data to influence and support quality improvement, and national surgical policies. Efforts to establish perioperative registries must continue while adhering to local ethical practices and broader principles and should consider those characteristics associated with successful registry implementation identified in this review.
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    Mapping perioperative randomised controlled trials in Sub-Saharan Africa: a scoping review
    (2025) Collier, Laila; Biccard, Bruce; Hohlfeld, ASJ
    Background: Surgical and anesthesia care is an integral component of universal healthcare coverage. In Sub-Saharan Africa (SSA), 93% of the population lacks access to essential surgical services. Post-surgery mortality in Africa is double the global average. The involvement of anesthesiologists is crucial for improved outcomes. Perioperative research can produce context-specific solutions to challenges faced in the perioperative period. SSA conducts fewer randomized controlled trials (RCTs) than high-income countries, limiting its contribution to global evidence. Objectives: Our primary objectives were to document the geographical distribution of included RCTs, describe their characteristics, and evaluate the reporting quality using the Consolidated Standards of Reporting Trials (CONSORT)-2010-checklist. Methods: We followed the PRISMA Scoping Reviews (PRISMAScR) Checklist. We searched MEDLINE, the Cochrane Library, and Scopus. We identified anesthesia-related RCTs within SSA published from 2000 to 2022. Two independent reviewers screened potential studies, and extracted data in duplicate, with disagreements resolved through consensus or a third reviewer. Quantitative analysis was done with STATA 16 and we compared RCT quality pre-CONSORT-2010 to post-CONSORT-2010, using Pearson's chi-squared test or Fisher's exact test (as applicable), considering p<0.05 as statistically significant. data were summarized narratively Results: Of 3319 records, 169 eligible RCTs were identified, randomizing 45376 participants, with a mean sample size of 98. Between the years 2000 and 2022, there was an exponential trend towards an increasing number of RCTs in SSA (y = 1,5619e0,1051x). The RCTs were from 16 countries in SSA. Most studies were single-country, single-center, led by authors from Nigeria (63/169, 37.3 %) and South Africa (41/169, 24.3%). Most interventions were conducted intraoperatively (n = 125/169, 74%). Pharmacotherapy interventions were most investigated (n = 64/169, 37.9%), followed by analgesic interventions (n = 42/169, 24.9%). The surgical discipline most investigated was obstetrics (n = 51/169, 30.2%). The reporting quality was generally poor, with most RCTs not adhering to CONSORT guidelines and failing to register on a trial registry. Conclusion: This scoping review provides a comprehensive overview of anesthesia-related RCTs in SSA, highlighting limitations such as small sample sizes, under-representation of high surgical burden disciplines, and poor reporting of study outcomes. The clinical trial capacity is limited to a few countries and institutions, and the methodological quality remains poor despite reporting guidelines. There is an opportunity to enhance context-appropriate RCTs in SSA by prioritizing high-quality research through collaborative efforts. Our findings serve as a resource for researchers, funders, and policymakers in anesthesia research in Africa to improve future RCT designs and reporting.
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    Myocardial injury after non-cardiac surgery: A prevalence study
    (2018) Coetzee, Ettienne; Biccard, Bruce; Dyer, Robert
    Background Worldwide, the number of patients suffering from surgical complications account for a significant burden on healthcare systems. Myocardial injury after non-cardiac surgery (MINS) is a new entity that has recently been identified as an independent risk factor associated with 30-day all-cause mortality. The risk of death increases approximately 10 fold following MINS in the perioperative period. Diagnosing myocardial injury in nonsurgical patients often relies on specific symptomatology and clinical findings combined with special investigations. However, in surgical patients, more than 80% of patients with postoperative myocardial injury will be asymptomatic, and hence the majority of diagnoses will be missed. Studies identifying the prevalence and risk factors for MINS have been conducted in countries with a different surgical population to South Africa. The primary outcome of this study was to investigate the prevalence of MINS after non-cardiac, elective, elevated risk surgery in South Africa. Methods Patients undergoing elevated risk, elective, non-cardiac surgery ≥ 45 years of age were enrolled via convenience sampling. The new 5th generation, high sensitivity cardiac troponin T (hscTnT) blood test was used to identify MINS. Blood samples were taken between 24 to 72 hours after surgery. Exclusion criteria included patients with known renal disease, a recent cardiac event, pulmonary embolism or sepsis. Results A total of 244 patients were included in the study. The prevalence of MINS was 4.9% (95% CI 2.2-7.6) which was not significantly different (p=0.078) to reports from international prospective observational studies. Conclusion Elective, elevated risk surgical patients in South Africa have a similar incidence of MINS when compared to patients from international studies. As the risk profile of South African patients is significantly lower than other similar international observational studies, it is possible that the prevalence of MINS is more common in South Africa, when patients are adjusted for cardiovascular risk profile. The burden of MINS on public health morbidity is therefore likely to be proportionally more in South Africa when compared to international reports. This may suggest that the calibration of international cardiovascular risk prediction models is incorrect for South African patients, or there are confounding comorbidities which should be included in South African cardiovascular risk prediction models. Larger studies are required to confirm this hypothesis however, and should also aim to address the need for appropriate cardiovascular risk predicting models in South Africa, to ensure timeous identification of patients at risk of MINS.
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    Postoperative outcomes associated with surgical care for women in Africa: an international risk-adjusted analysis
    (2022) Paterson, Amy Frances; Maswime, Salome; Biccard, Bruce
    Background There is an increasing call for a broader approach to women's surgical care in low- and middle-income countries, beyond access to caesarean section. While obstetric outcomes in Africa are well described, outcomes following non-obstetric surgical care for women in Africa are relatively unknown. Methods We did a secondary analysis of the African Surgical Outcomes Study (ASOS) focusing on severe postoperative complications (defined as death and severe complications) in females following non-obstetric, non-gynaecological surgical procedures. ASOS was a seven-day, African multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery in 25 African countries. These African outcomes were compared to international outcomes from the International Surgical Outcomes Study (ISOS) in a riskadjusted logistic regression analysis. Findings There were 1498 African participants and 18449 international participants who met the inclusion criteria. The African cohort were younger than the international cohort (47 (17) years versus 57 (17); p= <0·0001) and had a lower preoperative risk profile. Severe complications occurred in 41 (2·8%) of 1471 patients of the African cohort, and 431 (2·3%) of 18449 patients in the ISOS cohort, with in-hospital mortality following severe complications of 20/41 (48·8%) in ASOS and 78/431 (18·1%) in ISOS. The adjusted odds ratio for a woman in Africa developing a severe postoperative complication following elective non-obstetric, non-gynaecological surgery compared to the international incidence was 2·114 (95% CI 1·468 - 3·042, p<0·0001). Interpretation: Women living in Africa have double the odds of severe postoperative complications following elective non-obstetric, non-gynaecological surgery compared to the international incidence.
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    Preoperative testing and medical therapy intervention to improve perioperative outcomes in noncardiac surgical patients.
    (2023) Alphonsus, Christella; Biccard, Bruce; Rodseth Reitze
    Introduction: Cardiovascular disease is the leading cause of death worldwide and a growing concern in low-and-middle income countries, including those in Africa. Patients with cardiovascular disease often have poorly managed chronic conditions in the African setting, which impacts their outcome when they present for non-cardiac surgery. This cohort has an increased risk of perioperative cardiovascular complications. This series of studies explored evidence-based perioperative cardiovascular management strategies in patients with high-risk cardiac comorbidities presenting for non-cardiac surgery. Methods: This was achieved through five objectives which formed five separate but interconnected research studies. The first objective was to study the approach of natriuretic peptide-directed medical therapy in non-surgical patients to inform development of a preoperative protocol in surgical patients through a systematic review. The second objective was to conduct systematic review on exercise therapy in nonsurgical patients to inform development of a preoperative protocol in surgical patients. The third objective was to define the population who would need optimisation before surgery in the Western Cape, South Africa through a prospective observational study of risk stratification. The fourth objective was to explore the broader applicability of perioperative cardiovascular management of high-risk patients by examining cardiovascular outcomes after surgery on the African continent (a sub-study of a larger African cohort study). The fifth objective was to produce national guidelines on cardiovascular risk stratification in a South African and African surgical population. Main results: The systematic reviews showed potential utility for exercise therapy in the optimisation of cardiac patients for non-cardiac surgery. Medical therapy optimisation guided by natriuretic peptide testing did not demonstrate a consistent reduction in natriuretic peptides, but did support a potential mortality benefit in non-surgical patients. The cohort of cardiac patients presenting for non-cardiac surgery in the Western Cape carries significant cardiac risk and needs perioperative cardiovascular management. This was confirmed by the rate of adverse cardiovascular outcomes reported on the African continent. These data supported the development of context-specific national cardiovascular risk stratification guidelines. Conclusion: The cardiovascular burden and risk for perioperative cardiovascular complications presents a challenge in low- and middle-income countries like South Africa, and more broadly Africa. This is a growing phenomenon which needs the collaborative effort of perioperative physicians and the implementation of evidence-based strategies in perioperative cardiovascular management.
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    Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
    (2022-01-31) Marcucci, Maura; Painter, Thomas W; Conen, David; Leslie, Kate; Lomivorotov, Vladimir V; Sessler, Daniel; Chan, Matthew T V; Borges, Flavia K; Martínez Zapata, Maria J; Wang, C Y; Xavier, Denis; Ofori, Sandra N; Landoni, Giovanni; Efremov, Sergey; Kleinlugtenbelt, Ydo V; Szczeklik, Wojciech; Schmartz, Denis; Garg, Amit X; Short, Timothy G; Wittmann, Maria; Meyhoff, Christian S; Amir, Mohammed; Torres, David; Patel, Ameen; Duceppe, Emmanuelle; Ruetzler, Kurtz; Parlow, Joel L; Tandon, Vikas; Wang, Michael K; Fleischmann, Edith; Polanczyk, Carisi A; Jayaram, Raja; Astrakov, Sergey V; Rao, Mangala; VanHelder, Tomas; Wu, William K K; Cheong, Chao C; Ayad, Sabry; Abubakirov, Marat; Kirov, Mikhail; Bhatt, Keyur; de Nadal, Miriam; Likhvantsev, Valery; Iglesisas, Pilar P; Aguado, Hector J; McGillion, Michael; Lamy, Andre; Whitlock, Richard P.; Roshanov, Pavel; Stillo, David; Copland, Ingrid; Vincent, Jessica; Balasubramanian, Kumar; Bangdiwala, Shrikant I; Biccard, Bruce; Kurz, Andrea; Srinathan, Sadeesh; Petit, Shirley; Eikelboom, John; Richards, Toby; Gross, Peter L; Alfonsi, Pascal; Guyatt, Gordon; Belley-Cote, Emily; Spence, Jessica; McIntyre, William; Yusuf, Salim; Devereaux, P J
    Background For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. Discussion Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality. Trial registration ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.
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    The association between perioperative risk factors and the method of anaesthesia, and maternal and neonatal outcomes following caesarean delivery in Africa: a sub-study of a 7-day prospective observational cohort study
    (2022) Gerber, Carmen; Biccard, Bruce; Dyer, Robert; Bishop, David
    Background Maternal and neonatal mortality is high in Africa. The African Surgical Outcomes Study found that maternal mortality following caesarean delivery in Africa is 50 times higher than in highincome countries, and independently associated with obstetric haemorrhage and anaesthesia complications. Methods A sub-study was conducted of a seven-day, international, prospective, observational cohort study of patients undergoing caesarean delivery in Africa. The aims were to determine the association between preoperative risk factors and the method of anaesthesia, and to examine the association between method of anaesthesia and i) pre- and post-delivery hypotension, ii) severe anaesthesia complications, iii) maternal mortality, and iv) neonatal mortality. In addition, the association was examined between pre-delivery intraoperative hypotension and neonatal outcomes. The primary outcomes were maternal and neonatal in-hospital mortality censored at 30 days. Secondary outcomes were a composite of four severe anaesthesia complications, the association between method of anaesthesia and intraoperative hypotension, and that between hypotension and neonatal outcomes. Findings 3709 patients who received spinal (2968, 80%) or general anaesthesia (GA) (741, 20%) were recruited from 183 hospitals in 22 African countries from February to May 2016. Maternal mortality was higher with GA than spinal anaesthesia (11/729, 1.5%, versus 9/2881, 0.3%, p = 0.001), as was neonatal mortality (65/662, 9.8% versus 73/2669, 2.7%, p < 0.001). Independent predictors of GA as the method for caesarean delivery included gestational age, American Society of Anaesthesiologists (ASA) category, emergency surgery, eclampsia, placenta praevia, placental abruption, and ruptured uterus. Spinal anaesthesia was administered to 48/94 (51.1%) patients with eclampsia, 12/28 (42.9%) with cardiac disease, 14/19 (73.7%) with preoperative sepsis, 48/76 (63.2%) with antepartum haemorrhage, 30/55 (54.5%) with placenta praevia, 33/78 (42.3%) with placental abruption and 12/29 (41.4%) with a ruptured uterus. There was no association between method of anaesthesia and intraoperative hypotension. There was no association between pre-delivery hypotension and neonatal mortality, cardiopulmonary resuscitation, or Apgar scores at 1 and 5 minutes. Conclusion Analysis of a large cohort of patients undergoing anaesthesia for caesarean delivery in Africa, showed that a larger proportion than in high-income countries received GA, and indicated which patients were more likely to require GA. GA was associated with maternal mortality, neonatal mortality, and severe anaesthesia complications. Spinal anaesthesia was often administered to patients with eclampsia or at high risk for obstetric haemorrhage. Focussed training in the principles of selection of method of anaesthesia, and specifically in the skills of safe GA, are recommended.
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    The relationship between preoperative hypertension and intraoperative haemodynamic changes known to be associated with postoperative morbidity
    (2019) Crowther, Marcelle; Roodt, Francois; Biccard, Bruce
    Hypertension is not consistently associated with postoperative cardiovascular morbidity and therefore not considered a major peri-operative risk factor. However, hypertension may predispose to peri-operative haemodynamic changes known to be associated with perioperative morbidity and mortality, such as intra-operative hypotension and tachycardia. The objective of this study was to determine whether pre-operative hypertension was independently associated with haemodynamic changes known to be associated with adverse peri-operative outcomes. We performed a five-day multicentre, prospective, observational cohort study which included all adult inpatients undergoing elective, noncardiac, non-obstetric surgery. We recruited 343 patients of whom 164 (47.8%) were hypertensive. An intra-operative mean arterial pressure of 100 beats per minute) occurred in 126 (38.9%) patients, of which 61 (48.4%) were hypertensive. Multivariable logistic regression did not show an independent association between the stage of hypertension and either clinically significant hypotension or tachycardia, when controlled for ASA physical status, functional status, major surgery, the duration of surgery or blood transfusion. There was no association between pre-operative hypertension and peri-operative haemodynamic changes known to be associated with major morbidity and mortality. These data therefore support the recommendation of the Joint Guidelines of the Association of Anaesthetists of Great Britain and Ireland (AAGBI) and the British Hypertension Society to proceed with elective surgery if a patient’s blood pressure is < 180/110 mmHg.