RESUMEN
BACKGROUND: A Hip fracture in the intermediate-risk elderly patient is common and associated with a high rate of postoperative morbidity and mortality. There is a lack of consensus on the optimal anaesthetic technique but there is a clear association between intraoperative hypotension and postoperative morbidity and mortality. We aimed to compare the haemodynamic stability of three anaesthesia techniques: general anaesthesia (GA), continuous spinal anaesthesia (CSA), and multiple nerve blocks (MNB). METHODS: The primary outcome was the occurrence of intraoperative hypotension defined by a 30% decrease in mean arterial pressure (MAP) from baseline. Secondary outcomes included incidence of hypotension under 50 mmHg of MAP, time spent below MAP 50 mmHg, use of vasopressors, in-hospital and 30-day mortality. A propensity score-matched analysis was performed. RESULTS: After screening and application of the exclusion criteria, 593 patients undergoing hip fracture surgery between the 1st of January 2015 and the 31st of December 2016 were included. The propensity score match analysis selected 43 patients in each group. The incidence of hypotension was significantly higher in the GA group than in the MNB and CSA groups: 39 (90%), 22 (51%), and 23 (53.5%), respectively; p < 0.0001. The incidence of MAP < 50 mmHg (59.5%, 23.3%, and 16.3%; p < 0.0001) and the use of vasopressors (93%, 39.5%, and 25.6%; p < 0.0001) were increased significantly in the GA group. With the GA group as a reference, odds ratios were reported in the MNB group at 0.08 [0.022-0.30] (p = 0.0002) for hypotension episodes; 0.17 [0.04-0.66] (p = 0.01) for hypotension < 50 mmHg for more than 3 min and 0.049 [0.013-0.018] (p < 0.0001) for use of vasopressors. The duration of hospital stay, postoperative complications, in-hospital and 30-day mortality rates did not differ significantly between the groups. CONCLUSION: CSA and MNB provide better haemodynamic stability than GA. However, whatever the anaesthesia technique used, the mortality rates do not change even if MNB leads to less hypotension. IRB contact information: CERAR IRB 00010254-2016-118. Clinical Trial Number: ClinicalTrials.gov. ID: NCT03356704.
Asunto(s)
Anestesia Raquidea , Fracturas de Cadera , Hipotensión , Anciano , Anestesia General/efectos adversos , Anestesia Raquidea/efectos adversos , Fracturas de Cadera/cirugía , Humanos , Hipotensión/epidemiología , Puntaje de PropensiónRESUMEN
INTRODUCTION: Blood transfusion and anaemia are frequent and are associated with poor outcomes in patients with hip fracture (HF). We hypothesised that preoperative intravenous iron and tranexamic acid (TXA) may reduce the transfusion rate in these patients. METHODS AND ANALYSIS: The HiFIT study is a multicentre, 2×2 factorial, randomised, double-blinded, controlled trial evaluating the effect of iron isomaltoside (IIM) (20 mg/kg) vs placebo and of TXA (intravenously at inclusion and topically during surgery) versus placebo on transfusion rate during hospitalisation, in patients undergoing emergency surgery for HF and having a preoperative haemoglobin between 95 and 130 g/L. 780 patients are expected. The primary endpoint is the proportion of patients receiving an allogenic blood transfusion of packed red blood cells from the day of surgery until hospital discharge (or until D30 if patient is still hospitalised). Enrolment started on March 2017 in 11 French hospitals. The study was stopped between July 2017 and August 2018 (because of investigation of serious AEs with IIM in Spain) and slowed down since March 2020 (COVID-19 crisis). The expected date of final follow-up is May 2022. Analyses of the intent-to-treat and per-protocol populations are planned. ETHICS AND DISSEMINATION: The HiFIT trial protocol has been approved by the Ethics Committee of Comité de Protection des Personnes Ouest II and the French authorities (ANSM). It will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. The HiFIT trial will be the largest study evaluating iron and TXA in patients with HF. TRIAL REGISTRATION NUMBER: clinicalTrials.gov identifier: NCT02972294; EudraCT Number 2016-003087-40.