Efficacy and safety of intravenous tranexamic acid in microscopic modified radical mastoidectomy: a study protocol for a prospective, randomised, double-blind controlled trial.

INTRODUCTION: Radical mastoidectomy is a common procedure for chronic suppurative otitis media, typically performed under a microscope. The smooth operation is closely related to the clarity of the operative field. Our trial is designed to investigate whether the intravenous administration of tranexamic acid (TXA) can improve the clarity of the operative field, reduce the operative time, and increase surgeon satisfaction. METHODS AND ANALYSIS: This study is a prospective, randomised, double-blinded, controlled trial that aims to investigate the effects of TXA on patients with otitis media. The trial will include patients between the ages of 18 and 65 who will be randomly assigned to either the TXA group or the control group. In the TXA group, patients will receive 1 g of TXA diluted to 20 mL of normal saline before anaesthesia induction while the control group will receive 20 mL of normal saline. The primary outcome measure will be the Modena Bleeding Score, which will assess the clarity of the surgical field. Secondary outcomes will include the surgeon's satisfaction with surgical conditions, operation time, laboratory measurements (prothrombin time, activated partial thromboplastin time, fibrin degradation products, D-dimer) and levels of inflammatory factors (such as IL-6) at 24 hours postoperatively. In addition, the incidence of general adverse reactions such as postoperative nausea, vomiting and dizziness; serious adverse events such as arterial and venous thromboembolism, myocardial infarction and epilepsy within 90 days will be compared between the two groups. ETHICS AND DISSEMINATION: The protocol was approved by the Ethics Committee of Peking University People's Hospital (2021PHB173-001), on 19 July 2021. The trial results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2100049183.

Effect of regional block technique on postoperative high-grade complications according to Clavien-Dindo classification in elderly patients with thoracic and abdominal cancer: a retrospective propensity score matching analysis.

Background: Postoperative complications have an influence on postoperative rehabilitation, length of hospital stay and hospitalization expenses in elderly patients, especially those with higher Clavien-Dindo (C-D) classification. Patients with cancers often experience more serious postoperative complications after surgery. Different anesthesia methods can affect the postoperative outcomes of cancer patients. Regional block techniques have been recommended in guidelines for enhanced recovery after surgery. However, the relationship between regional blocks and high-grade postoperative complications remains unclear, thus, the study explored the relationship between regional block techniques and high-grade postoperative complications graded by C-D classification in elderly patients with thoracic and abdominal cancer. Method: Retrospective enrollment of eligible elderly patients admitted to Peking University People's Hospital between January 2018 and March 2022 was conducted. Propensity score matching (PSM) and univariate and multivariate regression analyses were used to analyze the potential benefits of regional blocks for elderly patients in real world practice. Results: A total of 2769 patients were enrolled in this study, including 568 who underwent colorectal resection, 2201 who underwent video-assisted thoracoscopic pneumonectomy. Among them, 2033 patients received regional block, while 736 patients did not. Statistical analysis indicated that regional blocks could reduce the incidence of postoperative complications of C-D classification Grade II or higher, with an Odds ratio (OR) of 0.742, 95% Confidence interval (CI) (0.552 to 0.996) (P = 0.047). Conclusion: Regional block is associated with a reduction in the occurrence of postoperative complications graded by C-D classification in elderly patients with thoracic and abdominal cancer. The application of regional blocks can lower the risk of high-risk complications and mortality.