Hypertonic saline for goal-directed therapy guided by Capstesia in gastrointestinal surgery: a randomized controlled study.

INTRODUCTION: Goal-directed fluid therapy (GDT) aims to increase stroke volume and cardiac output and improve gut perfusion. Hypertonic saline (HS) can restore the macro-and micro-circulation, increase myocardial contractility, and reduce tissue edema. Therefore, we aimed to investigate the efficacy of intraoperative HS administration in GDT during gastrointestinal (GI) surgery. MATERIAL AND METHODS: Forty patients who underwent GI surgery under general anesthesia were enrolled in this randomized controlled study. Patients received boluses of either lactated Ringer's (LR) solution, or 3% HS solution guided by an algorithm dependent on a smartphone application for estimations of pulse pressure variation (PPV). The primary outcome was the total amount of administered intraoperative crystalloid fluids in both groups. Serum sodium and time to first bowel movement after surgery were also recorded. RESULTS: In the HS group, patients received 1262.50 ± 318.25 mL of crystalloids compared to 2667.50 ± 670.29 mL received by patients in the LR group (P 0.05. CONCLUSIONS: The use of HS solution for GDT in GI surgery resulted in a beneficial reduction in positive fluid balance and possibly earlier resumption of bowel movements.

Ultrasound-guided transversalis fascia plane block versus transmuscular quadratus lumborum block for post-operative analgesia in inguinal hernia repair.

BACKGROUND: Inguinal hernia repair is one of the most commonly performed surgical procedures. Regional blocks might provide excellent analgesia and reduce complications in the postoperative period. We aimed to compare the postoperative analgesic effect of the ultrasound-guided transversalis fascia (TF) plane block versus the transmuscular quadratus lumborum (QL) block in patients undergoing unilateral inguinal hernia repair. METHODS: Fifty patients enrolled in this comparative study and were randomly assigned into two equal groups. One group received an ultrasound-guided QL block. In comparison, the other group received an ultrasound-guided TF plane block. The primary outcome was the patient-assessed resting, and movement-induced pain on the numeric pain rating scale (NRS) measured at 30 minutes postoperatively. Secondary outcomes included the percentage of patients receiving rescue analgesia in the first postoperative day, ease of performance of the technique, and incidence of adverse effects. RESULTS: There were no statistically significant differences in NRS at rest and with movement between the groups over the first 24 hours postoperatively. The proportion of patients that received postoperative rescue analgesics during the first 30 minutes postoperatively was 4% (n = 1) in the QL group compared to 12% (n = 3) in the TF group. However, the mean performance time of the TF block was shorter than that of the QL block, and the performance of the TF block appeared easier technically. CONCLUSIONS: The ultrasound-guided TF plane block could be as effective as the QL block in lowering pain scores and decreasing opioid consumption following non-recurrent inguinal herniorrhaphy.

In situ Analytical Quality Control of chemotherapeutic solutions in infusion bags by Raman spectroscopy.

Analytical Quality Control (AQC) in centralised preparation units of oncology centers is a common procedure relying on the identification and quantification of the prepared chemotherapeutic solutions for safe intravenous administration to patients. Although the use of Raman spectroscopy for AQC has gained much interest, in most applications it remains coupled to a flow injection analyser (FIA) requiring withdrawal of the solution for analysis. In addition to current needs for more rapid and cost-effective analysis, the risk of exposure of clinical staff to the toxic molecules during daily handling is a serious concern to address. Raman spectroscopic analysis, for instance by Confocal Raman Microscopy (CRM), could enable direct analysis (non-invasive) for AQC directly in infusion bags. In this study, 3 anticancer drugs, methotrexate (MTX), 5-fluorouracil (5-FU) and gemcitabine (GEM) have been selected to highlight the potential of CRM for withdrawal free analysis. Solutions corresponding to the clinical range of each drug were prepared in 5% glucose and data was collected from infusion bags placed under the Raman microscope. Firstly, 100% discrimination has been obtained by Partial Least Squares Discriminant Analysis (PLS-DA) confirming that the identification of drugs can be performed. Secondly, using Partial Least Squares Regression (PLSR), quantitative analysis was performed with mean % error of predicted concentrations of respectively 3.31%, 5.54% and 8.60% for MTX, 5-FU and GEM. These results are in accordance with the 15% acceptance criteria used for the current clinical standard technique, FIA, and the Limits of Detection for all drugs were determined to be substantially lower than the administered range, thus highlighting the potential of confocal Raman spectroscopy for direct analysis of chemotherapeutic solutions.

Understanding the discrimination and quantification of monoclonal antibodies preparations using Raman spectroscopy.

The use of Raman spectroscopy for analytical quality control of anticancer drug preparations in clinical pharmaceutical dispensing units is increasing in popularity, notably supported by commercially available, purpose designed instruments. Although not legislatively compulsory, analytical methods are frequently used post-preparation to verify the accuracy of a preparation in terms of identity and quantity of the drug in solution. However, while the rapid, cost effective and label free analysis achieved with Raman spectroscopy is appealing, it is important to understand the molecular origin of the spectral contributions collected from the solution of actives and excipients, to evaluate the strength and limitation for the technique, which can be used to identify and quantify either the prescribed commercial formulation, and/or the active drug itself, in personalised solutions. In the current study, four commercial formulations, Erbitux®, Truxima®, Ontruzant® and Avastin® of monoclonal antibodies (mAbs), corresponding respectively to cetuximab, rituximab, trastuzumab and bevacizumab have been used to highlight the key role of excipients in discrimination and quantification of the formulations. It is demonstrated that protein based anticancer drugs such as mAbs have a relatively weak Raman response, while excipients such as glycine, trehalose or histidine contribute significantly to the spectra. Multivariate analysis (partial least square regression and partial least square discriminant analysis) further demonstrates that the signatures of the mAbs themselves are not prominent in mathematical models and that those of the excipients are solely responsible for the differentiation of formulation and accurate determination of concentrations. While Raman spectroscopy can successfully validate the conformity of mAbs intravenous infusion solutions, the basis for the analysis should be considered, and special caution should be given to excipient compositions in commercial formulations to ensure reliability and reproducibility of the analysis.

Qualitative and quantitative analysis of therapeutic solutions using Raman and infrared spectroscopy.

Anticancer drugs are prescribed and administrated to an increasing number of patients on a daily basis. As a consequence, a number of concerns have been raised about the patient health and safety in the case that the drugs administered are not at the required concentration or even worse not the correct ones. Quality control of therapeutic solutions has therefore been extensively implemented in hospital environments, in order to avoid any failure in the intense workflow faced by administering pharmacists. In the present study, infrared (IR) and Raman spectroscopy have been employed for the analysis of 3 commercially available therapeutic solutions TEVA®, MYLAN®, CERUBIDINE®, respectively containing doxorubicin, epirubicin and daunorubicin. They perfectly illustrate the analytical difficulties encountered, as these 3 chemotherapeutic drugs are isomers, hardly distinguishable with conventional approaches such as UV/VIS spectrometry. Any analytical failure to identify these molecules can lead to delays in patient treatment. While Partial Least Squares Regression analysis demonstrates that both Raman and IR can deliver satisfactory quantitative analysis in the clinical range, with respective Root Mean Square Error of Cross Validation (RMSECV) between 0.0127 - 0.0220 g·L-1 and 0.0573 - 0.0759 g·L-1, the identification rate between the 2 techniques differs substantially. Indeed, Principal Component Analysis - Factorial Discriminant Analysis (PCA-FDA) highlights that, depending on the data preprocessing applied to Raman spectra, the discrimination between the 3 drugs is decreased, with in some cases specificity and sensitivity below 50%. However, IR analysis displays encouraging results with an overall specificity and sensitivity between 99 and 100%, suggesting that reliable validation of the therapeutic solution for administration to patients can be achieved. IR and Raman spectroscopy could assist and support quality control of chemotherapeutic solutions prepared in personalised concentrations for each patient. The effective and reliable characterisation of therapeutic solutions could have a lot to offer to improve current practices in a near future.