Method of Anesthesia and Perioperative Risk Factors, Maternal Anesthesia Complications, and Neonatal Mortality Following Cesarean Delivery in Africa: A Substudy of a 7-Day Prospective Observational Cohort Study.

BACKGROUND: The African Surgical Outcomes Study (ASOS) found that maternal mortality following cesarean delivery in Africa is 50 times higher than in high-income countries, and associated with obstetric hemorrhage and anesthesia complications. Mothers who died were more likely to receive general anesthesia (GA). The associations between GA versus spinal anesthesia (SA) and preoperative risk factors, maternal anesthesia complications, and neonatal outcomes following cesarean delivery in Africa are unknown. METHODS: This is a secondary explanatory analysis of 3792 patients undergoing cesarean delivery in ASOS, a prospective observational cohort study, across 22 African countries. The primary aim was to estimate the association between preoperative risk factors and the outcome of the method of anesthesia delivered. Secondary aims were to estimate the association between the method of anesthesia and the outcomes (1) maternal intraoperative hypotension, (2) severe maternal anesthesia complications, and (3) neonatal mortality. Generalized linear mixed models adjusting for obstetric gravidity and gestation, American Society of Anesthesiologists (ASA) category, urgency of surgery, maternal comorbidities, fetal distress, and level of anesthesia provider were used. RESULTS: Of 3709 patients, SA was performed in 2968 (80%) and GA in 741 (20%). Preoperative factors independently associated with GA for cesarean delivery were gestational age (adjusted odds ratio [aOR], 1.093; 95% confidence interval [CI], 1.052-1.135), ASA categories III (aOR, 11.84; 95% CI, 2.93-46.31) and IV (aOR, 11.48; 95% CI, 2.93-44.93), eclampsia (aOR, 3.92; 95% CI, 2.18-7.06), placental abruption (aOR, 6.23; 95% CI, 3.36-11.54), and ruptured uterus (aOR, 3.61; 95% CI, 1.36-9.63). SA was administered to 48 of 94 (51.1%) patients with eclampsia, 12 of 28 (42.9%) with cardiac disease, 14 of 19 (73.7%) with preoperative sepsis, 48 of 76 (63.2%) with antepartum hemorrhage, 30 of 55 (54.5%) with placenta previa, 33 of 78 (42.3%) with placental abruption, and 12 of 29 (41.4%) with a ruptured uterus. The composite maternal outcome "all anesthesia complications" was more frequent in GA than SA (9/741 [1.2%] vs 3/2968 [0.1%], P < .001). The unadjusted neonatal mortality was higher with GA than SA (65/662 [9.8%] vs 73/2669 [2.7%], P < .001). The adjusted analyses demonstrated no association between method of anesthesia and (1) intraoperative maternal hypotension and (2) neonatal mortality. CONCLUSIONS: Analysis of patients undergoing anesthesia for cesarean delivery in Africa indicated patients more likely to receive GA. Anesthesia complications and neonatal mortality were more frequent following GA. SA was often administered to high-risk patients, including those with eclampsia or obstetric hemorrhage. Training in the principles of selection of method of anesthesia, and the skills of safe GA and neonatal resuscitation, is recommended.

Tranexamic acid at cesarean delivery: drug-error deaths.

The use of tranexamic acid for postpartum hemorrhage has entered obstetrical practice globally with the evidence-based expectation of saving lives. This improvement in the care of women with postpartum hemorrhage has come at a price. For the anesthetist, having tranexamic acid ampoules close at hand would seem an obvious strategy to facilitate its use during cesarean delivery, an important setting for severe hemorrhage. Tragically, we have identified a number of recent instances of inadvertent intrathecal administration of tranexamic acid instead of local anesthetic for spinal anesthesia. Reported cases of this catastrophic error seem to be increasing. The profound neurotoxicity of tranexamic acid causes rapid-onset convulsions, with mortality of 50%. How can these tragic errors be averted? Drug safety alerts have been issued by the US Food and Drug Administration and the World Health Organization, but that is not enough. We recommend extensive dissemination of information to raise awareness of this potential hazard, and local hospital protocols to ensure that tranexamic acid is stored separately from anesthetic drugs, preferably outside the operating room and with an auxiliary warning label. Implementation of safety strategies on a very large scale will be needed to ensure that the life-saving potential of tranexamic acid is not eclipsed by drug-error mortality.

Tranexamic acid at cesarean delivery: Drug-error deaths.

The use of tranexamic acid for postpartum hemorrhage has entered obstetrical practice globally with the evidence-based expectation of saving lives. This improvement in the care of women with postpartum hemorrhage has come at a price. For the anesthetist, having tranexamic acid ampoules close at hand would seem an obvious strategy to facilitate its use during cesarean delivery, an important setting for severe hemorrhage. Tragically, we have identified a number of recent instances of inadvertent intrathecal administration of tranexamic acid instead of local anesthetic for spinal anesthesia. Reported cases of this catastrophic error seem to be increasing. The profound neurotoxicity of tranexamic acid causes rapid-onset convulsions, with mortality of 50%. How can these tragic errors be averted? Drug safety alerts have been issued by the US Food and Drug Administration and the World Health Organization, but that is not enough. We recommend extensive dissemination of information to raise awareness of this potential hazard, and local hospital protocols to ensure that tranexamic acid is stored separately from anesthetic drugs, preferably outside the operating room and with an auxiliary warning label. Implementation of safety strategies on a very large scale will be needed to ensure that the life-saving potential of tranexamic acid is not eclipsed by drug-error mortality.

Tranexamic acid at cesarean delivery: drug-error deaths.

The use of tranexamic acid for postpartum hemorrhage has entered obstetrical practice globally with the evidence-based expectation of saving lives. This improvement in the care of women with postpartum hemorrhage has come at a price. For the anesthetist, having tranexamic acid ampoules close at hand would seem an obvious strategy to facilitate its use during cesarean delivery, an important setting for severe hemorrhage. Tragically, we have identified a number of recent instances of inadvertent intrathecal administration of tranexamic acid instead of local anesthetic for spinal anesthesia. Reported cases of this catastrophic error seem to be increasing. The profound neurotoxicity of tranexamic acid causes rapid-onset convulsions, with mortality of 50%. How can these tragic errors be averted? Drug safety alerts have been issued by the US Food and Drug Administration and the World Health Organization, but that is not enough. We recommend extensive dissemination of information to raise awareness of this potential hazard, and local hospital protocols to ensure that tranexamic acid is stored separately from anesthetic drugs, preferably outside the operating room and with an auxiliary warning label. Implementation of safety strategies on a very large scale will be needed to ensure that the life-saving potential of tranexamic acid is not eclipsed by drug-error mortality.

Tranexamic acid at cesarean delivery: drug-error deaths.

The use of tranexamic acid for postpartum hemorrhage has entered obstetrical practice globally with the evidence-based expectation of saving lives. This improvement in the care of women with postpartum hemorrhage has come at a price. For the anesthetist, having tranexamic acid ampoules close at hand would seem an obvious strategy to facilitate its use during cesarean delivery, an important setting for severe hemorrhage. Tragically, we have identified a number of recent instances of inadvertent intrathecal administration of tranexamic acid instead of local anesthetic for spinal anesthesia. Reported cases of this catastrophic error seem to be increasing. The profound neurotoxicity of tranexamic acid causes rapid-onset convulsions, with mortality of 50%. How can these tragic errors be averted? Drug safety alerts have been issued by the US Food and Drug Administration and the World Health Organization, but that is not enough. We recommend extensive dissemination of information to raise awareness of this potential hazard, and local hospital protocols to ensure that tranexamic acid is stored separately from anesthetic drugs, preferably outside the operating room and with an auxiliary warning label. Implementation of safety strategies on a very large scale will be needed to ensure that the life-saving potential of tranexamic acid is not eclipsed by drug-error mortality.

Troubleshooting obstetric spinal anaesthesia at district hospital level.

Obstetric spinal anaesthesia is routinely used in South African district hospitals for caesarean sections, providing better maternal and neonatal outcomes than general anaesthesia in appropriate patients. However, practitioners providing anaesthesia in this context are usually generalists who practise anaesthesia infrequently and may be unfamiliar with dealing with complications of spinal anaesthesia or with conversion from spinal to general anaesthesia. This is compounded by challenges with infrastructure, shortages of equipment and sundries and a lack of context-sensitive guidelines and support from specialised anaesthetic services for district hospitals. This continuous professional development (CPD) article aims to provide guidance with respect to several key areas related to obstetric spinal anaesthesia, and to address common concerns and queries. We stress that good clinical practice is essential to avoid predictable, common complications, and hence a thorough preoperative preparation is essential. We further discuss clinical indications for preoperative blood testing, spinal needle choice, the use of isobaric bupivacaine, spinal hypotension, failed or partial spinal block and pain during the caesarean section. Where possible, relevant local and international guidelines are referenced for further reading and guidance, and a link to a presentation of this topic is provided.

Spinal hypotension in obstetrics: Context-sensitive prevention and management.

Spinal hypotension during caesarean section remains a common complication, with important attendant maternal and fetal adverse outcomes. Research elucidating the mechanisms of spinal hypotension has led to the development and refinement of effective management strategies, with a particular emphasis on prophylactic vasopressor administration. This has proved effective in well-resourced settings, with maternal comfort and the elimination of nausea now considered the primary aim of treatment. In resource-limited settings, sophisticated strategies are not feasible due to insufficient equipment, staff, and expertise. Therefore, in these areas spinal hypotension remains an important cause of maternal and fetal morbidity and mortality. Translational, context-sensitive research in resource-limited settings has shown promise in implementing pragmatic strategies based on research from resource-rich environments. We review the current best practice for the prevention and treatment of spinal hypotension, with a special emphasis on effective strategies in resource-limited settings. We further suggest a research agenda to address the knowledge gap in specific contexts.

Anaesthesia for ruptured ectopic pregnancy at district level.

In South Africa, deaths as a result of ectopic pregnancies are increasing despite the overall improvements in maternal mortality. These deaths occur predominantly in district hospitals, with the final cause of death being hypovolaemic shock in almost all cases. In most cases, no anaesthesia was attempted despite the district hospitals having the clinical skills, equipment and infrastructure to provide a caesarean delivery service. It appears that there is a skills gap between the provision of anaesthesia for caesarean delivery and that of ruptured ectopic pregnancy. There is a growing recognition of the urgent need to prioritise the provision of emergency surgical care in rural settings. This should be viewed not as a luxury but as an absolute necessity. In this study, we aim to discuss the pathophysiology of a patient with a ruptured ectopic pregnancy briefly, outline district hospital requirements for safe surgery and then discuss a simple, safe method for the provision of anaesthesia in patients deemed too unstable to transfer to a referral facility.

Prophylactic Phenylephrine Infusions to Reduce Severe Spinal Anesthesia Hypotension During Cesarean Delivery in a Resource-Constrained Environment.

Phenylephrine infusions are considered as standard management for obstetric spinal hypotension, but there remains reluctance to implement them in resource-limited contexts. This prospective, alternating intervention study of patients undergoing elective or urgent cesarean delivery under spinal anesthesia compared a vasopressor bolus strategy to fixed-rate, low-dose prophylactic phenylephrine infusion with supplemental boluses. The primary outcome was the incidence of severe hypotension (mean arterial pressure <70% baseline or systolic blood pressure <80 mm Hg). Fewer patients receiving prophylactic phenylephrine infusions had severe hypotension (47.4% [n = 120/253] vs 62.1% [n = 157/253], P = .001, estimated relative risk 0.84, 95% confidence interval, 0.69-1.02), with no significant difference in the rate of hypertension (15% [n = 39/253] vs 11% [n = 27/253], P = .11, estimated relative risk 1.39, confidence interval 0.87-2.20). Guidelines for resource-constrained settings should consider a fixed, low-dose phenylephrine infusion in combination with rescue vasopressor bolus therapy.

Recipes for obstetric spinal hypotension: The clinical context counts.

Hypotension following obstetric spinal anaesthesia remains a common and important problem. While recent research advances have brought us closer to the perfect recipe for the obstetric spinal anaesthetic, these advances have not been translated into practical guidelines able to reduce the unacceptable number of fatalities that occur in environments where resources are limited. In South Africa, more than half of anaesthetic deaths are still related to spinal hypotension. A gap exists between the 'perfect recipe', developed from a clinical context rooted in resource-rich research environments, and its application and performance in real-world resource-poor environments - conditions experienced by more than 75% of the world's population. This review attempts to define this knowledge gap and proposes a research agenda to address the deficiencies.

National priorities for perioperative research in South Africa.

BACKGROUND: Perioperative research is currently unco-ordinated in South Africa (SA), with no clear research agenda. OBJECTIVE: To determine the top ten national research priorities for perioperative research in SA. METHODS: A Delphi technique was used to establish consensus on the top ten research priorities. RESULTS: The top ten research priorities were as follows: (i) establishment of a national database of (a) critical care outcomes, and (b) critical care resources; (ii) a randomised controlled trial of preoperative B-type natriuretic peptide-guided medical therapy to decrease major adverse cardiac events following non-cardiac surgery; (iii) a national prospective observational study of the outcomes associated with paediatric surgical cases; (iv) a national observational study of maternal and fetal outcomes following operative delivery in SA; (v) a stepped-wedge trial of an enhanced recovery after surgery programme for (a) surgery, (b) obstetrics, (c) emergency surgery, and (d) trauma surgery; (vi) a stepped-wedge trial of a surgical safety checklist on patient outcomes in SA; (vii) a prospective observational study of perioperative outcomes after surgery in district general hospitals in SA; (viii) short-course interventions to improve anaesthetic skills in rural doctors; (ix) studies of the efficacy of simulation training to improve (a) patient outcomes, (b) team dynamics, and (c) leadership; and (x) development and validation of a risk stratification tool for SA surgery based on the South African Surgical Outcomes Study (SASOS) data. CONCLUSIONS: These research priorities provide the structure for an intermediate-term research agenda.