Marilena Marmiere

BACKGROUND: Major noncardiac surgery is associated with high rates of postoperative myocardial injury and other complications. Remote ischemic preconditioning (RIPC) was reported to decrease these complication rates. However, such supportive evidence lacks robustness. METHODS: In a multinational, double-blind trial, we randomly assigned adult high-risk patients undergoing noncardiac surgical procedures to receive RIPC or sham RIPC after the induction of general anesthesia and before surgery. RIPC involved three 5-minute ischemic cycles, each followed by 5 minutes of reperfusion, using a blood pressure cuff inflated to 200 mm Hg. The primary end point was the rate of myocardial injury, defined by an increase in postoperative troponin levels above the highest 99th percentile of reference values. Secondary outcomes included myocardial infarction, stroke, acute kidney injury, need for intensive care unit, length of hospital stay, and 30-day all-cause mortality. RESULTS: We recruited 1213 patients in 25 hospitals and 8 countries. We randomly assigned 599 patients to RIPC and 614 to sham RIPC. The most frequent surgical procedures were abdominal or intrathoracic surgeries (406 patients [33.6%]). RIPC was applied to the upper limb in 1014 patients (84.8%) and to the lower limb in 182 patients (15.2%). Postoperative myocardial injury occurred in 215 of 566 patients (38.0%) in the RIPC group and in 223 of 596 patients (37.4%) in the sham RIPC group (relative risk, 1.02 [95% CI, 0.88–1.18; P =0.84). There were no significant differences in the rate of any secondary outcomes. We observed 11 episodes of limb petechiae (10 [1.7%] in the RIPC group versus one [0.2%] in the sham RIPC group) and 34 (6.0%) hospital readmissions in the RIPC group versus 20 (3.5%) in the sham RIPC group. CONCLUSIONS: Among adult patients undergoing noncardiac surgery, RIPC did not reduce myocardial injury or other postoperative complications. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02427867.

The Statistical Analyses Of The Study "Sufentanil Sublingual Tablet System (SSTS) For The Management Of Postoperative Pain After Major Abdominal And Gynecological Surgery Within An ERAS Protocol: An Observational Study" [Response To Letter] Stefano Turi, Francesco Deni, Gaetano Lombardi, Marilena Marmiere, Francesco Giuseppe Nisi, Luigi Beretta Dipartimento di Anestesia, Ospedale San Raffaele, Milano, ItalyCorrespondence: Stefano TuriDepartment of Anesthesiology, Vita-Salute, University, San Raffaele Hospital, Via Olgettina 60, Milan 20132, ItalyTel + 39 02 2 643 2656Email turi.stefano@hsr.it Dear editor We thank Wang and Miao1 for their interest in our recent publication2 and the appreciation of our work. We agree with them on the need of using repeated-measures analysis to evaluate pain intensity at different timepoints. We acknowledge that, for the sake of brevity, our manuscript did not properly clarify the statistical methods used for the analysis and we take this opportunity to better explain them. We performed a repeated measure analysis of variance (ANOVA) to compare pain intensity on different time points. The analysis resulted statistically significant (p

Background: The Sufentanil Sublingual Tablet System (SSTS) is a new, pre-programmed, noninvasive, handheld system for patient-controlled analgesia (PCA) which may allow a faster postoperative recovery compared with standard PCA. The efficacy of SSTS in controlling pain after open abdominal surgery has already been documented. However, to our knowledge SSTS has never been investigated in patients undergoing major surgery within an Enhanced Recovery After Surgery (ERAS) protocol. Methods: This observational, retrospective analysis included consecutive patients undergoing elective major abdominal and gynecological surgery. All patients received the SSTS device once they were fully awake and had a good control of pain at the end of the surgery. We analyzed changes in pain intensity according to the numerical rating scale (NRS) throughout the treatment as well as its duration, the number of administrations, and possible related adverse events. Patients were also interviewed to assess their quality of sleep and overall satisfaction with the SSTS device. Results: The study included 308 patients. Compared to the first SSTS administration, pain intensity decreased from a median NRS of 6 to 0 at day 3, for an overall reduction of 79%. Results were already statistically significant at postoperative day 1 (pConclusions: Although the retrospective and observational nature of the study as well as the absence of a comparative group limits the strength of evidence, our results consider SSTS an effective and safe tool for the management of postoperative pain after major abdominal and gynecological surgery within an ERAS protocol.