Driving pressure during general anesthesia for open abdominal surgery (DESIGNATION) : study protocol of a randomized clinical trial

Background Intraoperative driving pressure (Delta P) is associated with development of postoperative pulmonary complications (PPC). When tidal volume (V-T) is kept constant, Delta P may change according to positive end-expiratory pressure (PEEP)-induced changes in lung aeration. Delta P may decrease if PEEP leads to a recruitment of collapsed lung tissue but will increase if PEEP mainly causes pulmonary overdistension. This study tests the hypothesis that individualized high PEEP, when compared to fixed low PEEP, protects against PPC in patients undergoing open abdominal surgery. Methods The "Driving prESsure durIng GeNeral AnesThesIa for Open abdomiNal surgery trial" (DESIGNATION) is an international, multicenter, two-group, double-blind randomized clinical superiority trial. A total of 1468 patients will be randomly assigned to one of the two intraoperative ventilation strategies. Investigators screen patients aged >= 18 years and with a body mass index <= 40 kg/m(2), scheduled for open abdominal surgery and at risk for PPC. Patients either receive an intraoperative ventilation strategy with individualized high PEEP with recruitment maneuvers (RM) ("individualized high PEEP") or one in which PEEP of 5 cm H2O without RM is used ("low PEEP"). In the "individualized high PEEP" group, PEEP is set at the level at which Delta P is lowest. In both groups of the trial, V-T is kept at 8 mL/kg predicted body weight. The primary endpoint is the occurrence of PPC, recorded as a collapsed composite of adverse pulmonary events. Discussion DESIGNATION will be the first randomized clinical trial that is adequately powered to compare the effects of individualized high PEEP with RM versus fixed low PEEP without RM on the occurrence of PPC after open abdominal surgery. The results of DESIGNATION will support anesthesiologists in their decisions regarding PEEP settings during open abdominal surgery

Impact of Procedural Sedation on the Clinical Outcome of Microelectrode Recording Guided Deep Brain Stimulation in Patients with Parkinson's Disease

BACKGROUND: Subthalamic nucleus (STN) deep brain stimulation (DBS) has become a routine treatment of advanced Parkinson's disease (PD). DBS surgery is commonly performed under local anesthesia (LA) to obtain reliable microelectrode recordings. However, procedural sedation and/or analgesia (PSA) is often desirable to improve patient comfort. The impact of PSA in addition to LA on outcome is largely unknown. Therefore, we performed an observational study to assess the effect of PSA compared to LA alone during STN DBS surgery on outcome in PD patients. METHODS: Seventy PD patients (22 under LA, 48 under LA + PSA) scheduled for STN DBS implantation were included. Dexmedetomidine, clonidine or remifentanil were used for PSA. The primary outcome was the change in Movement Disorders Society Unified Parkinson's Disease Rating Score III (MDS-UPDRS III) and levodopa equivalent daily dosage (LEDD) between baseline, one month before surgery, and twelve months postoperatively. Secondary outcome measures were motor function during activities of daily living (MDS-UPDRS II), cognitive alterations and surgical adverse events. Postoperative assessment was conducted in "on" stimulation and "on" medication conditions. RESULTS: At twelve months follow-up, UPDRS III and UPDRS II scores in "on" medication conditions were similar between the LA and PSA groups. The two groups showed a similar LEDD reduction and an equivalent decline in executive function measured by the Stroop Color-Word Test, Trail Making Test-B, and verbal fluency. The incidence of perioperative and postoperative adverse events was similar between groups. CONCLUSION: This study demonstrates that PSA during STN DBS implantation surgery in PD patients was not associated with differences in motor and non-motor outcome after twelve months compared with LA only

Routine Postsurgical Anesthesia Visit to Improve 30-Day Morbidity and Mortality:A Multicenter, Stepped-Wedge Cluster Randomized Interventional Study (the TRACE Study)

OBJECTIVE: To study the impact of a standardized postoperative anesthesia visit on 30-day mortality in medium to high-risk elective surgical patients. BACKGROUND: Postoperative complications are the leading cause of perioperative morbidity and mortality. While modified early warning scores (MEWS) were instituted to monitor vital functions and improve postoperative outcome, we hypothesized that complementary anesthesia expertise is needed to adequately identify early deterioration. METHODS: In a prospective, multicenter, stepped-wedge cluster randomized interventional study in nine academic and non-academic hospitals in the Netherlands, we studied the impact of adding standardized postoperative anesthesia visits on day one and three to routine use of MEWS in 5473 patients undergoing elective non-cardiac surgery. Primary outcome was 30-day mortality. Secondary outcomes included: incidence of postoperative complications, length of hospital stay and intensive care unit (ICU) admission. RESULTS: Patients were enrolled between October 2016 and August 2018. Informed consent was obtained from 5473 patients of which 5190 were eligible for statistical analyses, 2490 in the control and 2700 in the intervention group. Thirty-day mortality was 0·56% (n = 14) in the control and 0·44% (n = 12) in the intervention group (odds ratio 0·74, 95%confidence interval 0·34-1·62). Incidence of postoperative complications did not differ between groups except for renal complications which was higher in the control group (1·7% (n = 41) vs. 1·0% (n = 27), p = 0·014). Median length of hospital stay did not differ significantly between groups. During the post-anesthesia visits, for 16% (n = 437) and 11% (n = 293) of patients recommendations were given on day one and three, respectively, of which 67% (n = 293) and 69% (n = 202) were followed up. CONCLUSIONS: The combination of MEWS and a postoperative anesthesia visit did not reduce 30-day mortality. Whether a postoperative anesthesia visit with strong adherence to the recommendations provided and in a high-risk population might have a stronger impact on postoperative mortality remains to be determined. TRIAL REGISTRATION: Netherlands Trial Registration, NTR5506/ NL5249, https://www.trialregister.nl/trial/5249