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JAMA Aug 2023Intravenous magnesium sulfate administered to pregnant individuals before birth at less than 30 weeks' gestation reduces the risk of death and cerebral palsy in their... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Intravenous magnesium sulfate administered to pregnant individuals before birth at less than 30 weeks' gestation reduces the risk of death and cerebral palsy in their children. The effects at later gestational ages are unclear.
OBJECTIVE
To determine whether administration of magnesium sulfate at 30 to 34 weeks' gestation reduces death or cerebral palsy at 2 years.
DESIGN, SETTING, AND PARTICIPANTS
This randomized clinical trial enrolled pregnant individuals expected to deliver at 30 to 34 weeks' gestation and was conducted at 24 Australian and New Zealand hospitals between January 2012 and April 2018.
INTERVENTION
Intravenous magnesium sulfate (4 g) was compared with placebo.
MAIN OUTCOMES AND MEASURES
The primary outcome was death (stillbirth, death of a live-born infant before hospital discharge, or death after hospital discharge before 2 years' corrected age) or cerebral palsy (loss of motor function and abnormalities of muscle tone and power assessed by a pediatrician) at 2 years' corrected age. There were 36 secondary outcomes that assessed the health of the pregnant individual, infant, and child.
RESULTS
Of the 1433 pregnant individuals enrolled (mean age, 30.6 [SD, 6.6] years; 46 [3.2%] self-identified as Aboriginal or Torres Strait Islander, 237 [16.5%] as Asian, 82 [5.7%] as Māori, 61 [4.3%] as Pacific, and 966 [67.4%] as White) and their 1679 infants, 1365 (81%) offspring (691 in the magnesium group and 674 in the placebo group) were included in the primary outcome analysis. Death or cerebral palsy at 2 years' corrected age was not significantly different between the magnesium and placebo groups (3.3% [23 of 691 children] vs 2.7% [18 of 674 children], respectively; risk difference, 0.61% [95% CI, -1.27% to 2.50%]; adjusted relative risk [RR], 1.19 [95% CI, 0.65 to 2.18]). Components of the primary outcome did not differ between groups. Neonates in the magnesium group were less likely to have respiratory distress syndrome vs the placebo group (34% [294 of 858] vs 41% [334 of 821], respectively; adjusted RR, 0.85 [95% CI, 0.76 to 0.95]) and chronic lung disease (5.6% [48 of 858] vs 8.2% [67 of 821]; adjusted RR, 0.69 [95% CI, 0.48 to 0.99]) during the birth hospitalization. No serious adverse events occurred; however, adverse events were more likely in pregnant individuals who received magnesium vs placebo (77% [531 of 690] vs 20% [136 of 667], respectively; adjusted RR, 3.76 [95% CI, 3.22 to 4.39]). Fewer pregnant individuals in the magnesium group had a cesarean delivery vs the placebo group (56% [406 of 729] vs 61% [427 of 704], respectively; adjusted RR, 0.91 [95% CI, 0.84 to 0.99]), although more in the magnesium group had a major postpartum hemorrhage (3.4% [25 of 729] vs 1.7% [12 of 704] in the placebo group; adjusted RR, 1.98 [95% CI, 1.01 to 3.91]).
CONCLUSIONS AND RELEVANCE
Administration of intravenous magnesium sulfate prior to preterm birth at 30 to 34 weeks' gestation did not improve child survival free of cerebral palsy at 2 years, although the study had limited power to detect small between-group differences.
TRIAL REGISTRATION
anzctr.org.au Identifier: ACTRN12611000491965.
Topics: Adult; Female; Humans; Infant; Infant, Newborn; Pregnancy; Australia; Cerebral Palsy; Gestational Age; Infant Mortality; Magnesium Sulfate; Maori People; Premature Birth; Prenatal Care; Pregnancy Outcome; Administration, Intravenous; New Zealand; Child, Preschool; Young Adult; Pacific Island People; Asian; Australian Aboriginal and Torres Strait Islander Peoples; White
PubMed: 37581672
DOI: 10.1001/jama.2023.12357 -
British Journal of Anaesthesia Nov 2023Trials have demonstrated lower rates of acute kidney injury in critically ill patients receiving magnesium supplementation, but they have yielded conflicting results...
BACKGROUND
Trials have demonstrated lower rates of acute kidney injury in critically ill patients receiving magnesium supplementation, but they have yielded conflicting results regarding mortality.
METHODS
This is a retrospective cohort study based on the MIMIC-IV (Medical Information Mart in Intensive Care-IV) database. Adult critically ill patients with sepsis were included in the analysis. The exposure was magnesium sulfate use during ICU stay. The primary outcome was 28-day all-cause mortality. Propensity score matching (PSM) was conducted at a 1:1 ratio. Multivariable analyses were used to adjust for confounders.
RESULTS
The pre-matched and propensity score-matched cohorts included 10 999 and 6052 patients, respectively. In the PSM analysis, 28-day all-cause mortality rate was 20.2% (611/3026) in the magnesium sulfate use group and 25.0% (757/3026) in the no use group. Magnesium sulfate use was associated with lower 28-day all-cause mortality (hazard ratio [HR], 0.70; 95% CI, 0.61-0.79; P<0.001). Lower mortality was observed regardless of baseline serum magnesium status: for hypomagnesaemia, HR, 0.64; 95% confidence interval (CI), 0.45-0.93; P=0.020; for normomagnesaemia, HR, 0.70; 95% CI, 0.61-0.80; P<0.001. Magnesium sulfate use was also associated with lower ICU mortality (odds ratio [OR], 0.52; 95% CI, 0.42-0.64; P<0.001), lower in-hospital mortality (OR, 0.65; 95% CI, 0.55-0.77; P<0.001), and renal replacement therapy (OR, 0.67; 95% CI, 0.52-0.87; P=0.002). A sensitivity analysis using the entire cohort also demonstrated lower 28-day all-cause mortality (HR, 0.62; 95% CI, 0.56-0.69; P<0.001).
CONCLUSIONS
Magnesium sulfate use was associated with lower mortality in critically ill patients with sepsis. Prospective studies are needed to verify this finding.
Topics: Adult; Humans; Retrospective Studies; Magnesium Sulfate; Cohort Studies; Magnesium; Critical Illness; Propensity Score; Sepsis; Intensive Care Units
PubMed: 37684164
DOI: 10.1016/j.bja.2023.08.005 -
Medical Science Monitor : International... Jul 2023Eclampsia is the most serious pregnancy complication and one of the main causes of death of pregnant and delivering women. The mortality rate of young mothers is 5-20%,... (Review)
Review
Eclampsia is the most serious pregnancy complication and one of the main causes of death of pregnant and delivering women. The mortality rate of young mothers is 5-20%, emphasizing the severity of this pregnancy-related disorder. Today many centers have only rare opportunities to see and deal with eclampsia cases; therefore, it is very important to bring this emergency medical condition to the attention of attending physicians. All patients with eclampsia, and after eclamptic seizures, should be treated in an intensive care unit. However, taking into account clinical realities, especially in developing countries, this is not always possible. It is necessary for all gynecologists-obstetricians to be fully prepared for eclampsia, although its occurrence is very rare. Drug treatment aims to stop eclampsia seizures and prevent reoccurrence of convulsions and complications. Magnesium sulphate is the drug of first choice used in treatment of eclampsia seizure, whereas treatment with the use of antihypertensive drugs and proper blood pressure control is one of the most important factors effectively reducing the risk of deaths or acute complications and poor pregnancy outcomes. The most urgent part of the treatment is the lifesaving procedure involving airways patency assessment, maintenance of breathing and blood circulation of the mother, securing an adequate oxygen level of the mother and thereby of the fetus, and prevention of injuries. This review aims to present an overview of the current prevalence, diagnosis, and management of eclampsia and the need for improved maternal care.
Topics: Pregnancy; Female; Humans; Eclampsia; Magnesium Sulfate; Pregnancy Complications; Pregnancy Outcome; Seizures; Pre-Eclampsia
PubMed: 37415326
DOI: 10.12659/MSM.939919 -
American Journal of Obstetrics and... Dec 2023Magnesium sulfate reduces the risk for eclamptic seizures antepartum, intrapartum, and in the immediate postpartum period, however, there are no studies that have...
Magnesium sulfate reduces the risk for eclamptic seizures antepartum, intrapartum, and in the immediate postpartum period, however, there are no studies that have evaluated the benefits and risks of magnesium sulfate among women with late postpartum severe hypertension only. Juxtaposed on this clinical uncertainty is the increased incidence of severe hypertension owing to a rise in pregnancies complicated by advanced maternal age, obesity, chronic hypertension, diabetes, and recent protocols for intensive monitoring of blood pressure in the postpartum period. These factors have led to a significant increase in postpartum presentations for the evaluation and management of severe hypertension, in some cases leading to postpartum readmissions for administration of antihypertensive therapy and magnesium sulfate without data demonstrating clear clinical benefit. Postpartum readmissions can have several negative consequences, including interfering with early bonding with a newborn, breastfeeding, and use of scarce healthcare resources. In addition, magnesium sulfate is associated with risks for serious cardiorespiratory depression and bothersome side effects and can delay determining the optimal antihypertensive regimen, which is typically the most pressing clinical need during postpartum presentations of late-postpartum severe hypertension. Eclampsia that occurs more than 48 hours after delivery is rare (constitutes 16% of all cases of eclampsia) and is most commonly preceded by headaches or other cerebral symptoms. In this commentary, we propose an approach to evaluating and managing patients with late postpartum severe hypertension aimed at identifying those women at highest risk for end-organ injury. We recommend that the short- and long-term focus for all patients with severe hypertension should be the optimal management of blood pressures with a goal of close outpatient monitoring when logistically feasible and clinically appropriate. We suggest reserving magnesium sulfate therapy for the subset of patients with neurologic symptoms who may be at highest risk for an eclamptic seizure.
Topics: Pregnancy; Infant, Newborn; Humans; Female; Magnesium Sulfate; Eclampsia; Pre-Eclampsia; Antihypertensive Agents; Clinical Decision-Making; Uncertainty; Postpartum Period; Seizures; Hypertension
PubMed: 37467840
DOI: 10.1016/j.ajog.2023.07.021 -
Anesthesiology Apr 2024Opioid-free anesthesia is increasingly being adopted to reduce opioid consumption, but its impact on early postoperative recovery after major surgery has not been...
BACKGROUND
Opioid-free anesthesia is increasingly being adopted to reduce opioid consumption, but its impact on early postoperative recovery after major surgery has not been evaluated in comparative trials. The hypothesis was that an opioid-free anesthesia protocol would enhance the early quality of recovery for patients undergoing scheduled major surgery under general anesthesia.
METHODS
The SOFA study was a monocentric, randomized, controlled, assessor- and patient-blinded clinical trial conducted from July 10, 2021, to February 12, 2022. The eligible population included male and female patients undergoing scheduled major surgery, excluding bone procedures, that typically require opioids for postoperative pain management. Patients in the intervention group received a combination of at least two drugs among ketamine, lidocaine, clonidine, and magnesium sulfate, without opioids for anesthesia. The standard group received opioids. The primary outcome was early postoperative quality of recovery, assessed by Quality of Recovery-15 score at 24 h after surgery. Secondary outcomes were Quality of Recovery-15 at 48 and 72 h after surgery, incidence of chronic pain, and quality of life at 3 months.
RESULTS
Of the 136 randomized patients, 135 were included in the primary analysis (mean age, 45.9 ± 15.7 yr; 116 females [87.2%]; 85 underwent major plastic surgery [63.9%]), with 67 patients in the opioid-free anesthesia group and 68 in the standard group. The mean Quality of Recovery-15 at 24 h was 114.9 ± 15.2 in the opioid-free anesthesia group versus 108.7 ± 18.1 in the standard group (difference, 6.2; 95% CI, 0.4 to 12.0; P = 0.026). Quality of Recovery-15 scores also differed significantly at 48 h (difference, 8.7; 95% CI, 2.9 to 14.5; P = 0.004) and at 72 h (difference, 7.3; 95% CI, 1.6 to 13.0; P = 0.013). There were no differences in other secondary outcomes. No major adverse events were noticed.
CONCLUSIONS
The opioid-free anesthesia protocol improved quality of recovery after major elective surgery in a statistically but not clinically significant manner when compared to standard anesthesia.
Topics: Humans; Male; Female; Adult; Middle Aged; Analgesics, Opioid; Quality of Life; Pain, Postoperative; Lidocaine; Anesthesia, General; Randomized Controlled Trials as Topic
PubMed: 37976460
DOI: 10.1097/ALN.0000000000004840