Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial.

The Nociception Level index (NOL™) is a multiparameter index, based on artificial intelligence for the monitoring of nociception during anesthesia. We studied the influence of NOL-guided analgesia on postoperative pain scores in patients undergoing major abdominal surgery during sevoflurane/fentanyl anesthesia. This study was designed as a single-center, prospective randomized, controlled study. After Institutional Review Board approval and written informed consent, 75 ASA 1-3 adult patients undergoing major abdominal surgery, were randomized to NOL-guided fentanyl dosing (NOL) or standard care (SOC) and completed the study. The sevoflurane target MAC range was 0.8-1.2. In the NOL-guided group (N = 36), when NOL values were > 25 for at least 1 min, a weight adjusted fentanyl bolus was administered. In the control group (N = 39) fentanyl administration was based on hemodynamic indices and clinician judgement. After surgery, pain, was evaluated using the Numerical Rating Scale (NRS) pain scale, ranging from 0 to 10, at 15 min intervals for 180 min or until patient discharge from the PACU. Median postoperative pain scores reported were 3.0 [interquartile range 0.0-5.0] and 5.0 [3.0-6.0] at 90 min in NOL-guided and control groups respectively (Bootstrap corrected actual difference 1.5, 95% confidence interval 0.4-2.6). There was no difference in postoperative morphine consumption or intraoperative fentanyl consumption. Postoperative pain scores were significantly improved in nociception level index-guided patients. We attribute this to more objective fentanyl dosing when timed to actual nociceptive stimuli during anesthesia, contributing to lower levels of sympathetic activation and surgical stress. Clinicaltrials.gov identifier: NCT03970291 date of registration May 31, 2019.

Implementing capnography to help improve patient safety during procedural sedation: quality improvement in a high-volume gastroenterology department.

OBJECTIVE: Respiratory compromise is a major cause of adverse events during procedural sedation; continuous monitoring is vital for identifying and halting decompensation. We performed a quality improvement investigation to assess patient safety during procedural sedation in gastroenterology and the impact of implementing capnography monitoring. PATIENTS AND METHODS: Sedation-related adverse events and interventions were prospectively recorded during the endoscopic procedure and in recovery. Assuming rates in published literature, power analysis determined that at least 1332 patients were required to show a 20% improvement in patient safety. Recorded sedation-related adverse events (mild and severe oxygen desaturations, bradycardia and tachycardia) and interventions were anonymized and aggregated to evaluate the quality improvement. Patient safety under current care was determined before capnography (Medtronic) was implemented in combination with training. RESULTS: Between February 2018 and April 2018, a baseline (1092 patients) for outcomes under current care was completed, with 11.45 events per 100 procedures recorded. Between May 2018 and July 2018, 1044 procedures including capnography monitoring were performed with 5.08 events per 100 procedures recorded. The distribution of American Society of Anesthesiologists scores and procedure types between baseline and capnography were comparable. The absolute difference between baseline and capnography was -6.4 events per 100 procedures [95% confidence interval (CI), -4.1 to -8.7; P ≤ 0.0001]. The 55% reduction in adverse events surpassed the 20% improvement in patient safety set as the goal of this quality improvement. After multivariate regression, the adjusted odds ratio for events after implementation of capnography was 0.46 (95% CI, 0.32-0.66). CONCLUSIONS: Addition of capnography to current care significantly decreased procedure-related safety events.

Clinical and economic burden of procedural sedation-related adverse events and their outcomes: analysis from five countries.

BACKGROUND: Studies have reported on the incidence of sedation-related adverse events (AEs), but little is known about their impact on health care costs and resource use. METHODS: Health care providers and payers in five countries were recruited for an online survey by independent administrators to ensure that investigators and respondents were blinded to each other. Surveys were conducted in the local language and began with a "screener" to ensure that respondents had relevant expertise and experience. Responses were analyzed using Excel and R, with the Dixon's Q statistic used to identify and remove outliers. Global and country-specific average treatment patterns were calculated via bootstrapping; costs were mean values. The sum product of costs and intervention probability gave a cost per AE. RESULTS: Responses were received from 101 providers and 26 payers, the majority having >5 years of experience. At a minimum, the respondents performed a total of 3,430 procedural sedations per month. All AEs detailed occurred in clinical practice in the last year and were reported to cause procedural delays and cancellations in some patients. Standard procedural sedation costs ranged from €74 (Germany) to $2,300 (US). Respondents estimated that AEs would increase costs by between 16% (Italy) and 179% (US). Hypotension was reported as the most commonly observed AE with an associated global mean cost (interquartile range) of $43 ($27-$68). Other frequent AEs, including mild hypotension, bradycardia, tachycardia, mild oxygen desaturation, hypertension, and brief apnea, were estimated to increase health care spending on procedural sedation by $2.2 billion annually in the US. CONCLUSION: All sedation-related AEs can increase health care costs and result in substantial delays or cancellations of subsequent procedures. The prevention of even minor AEs during procedural sedation may be crucial to ensuring its value as a health care service.