Maintenance of beta-blockers and cardiac surgery-related outcomes: a prospective propensity-matched multicentre analysis.

BACKGROUND: We investigated the effects of maintaining beta-blockers on the day of surgery on the incidence of atrial fibrillation and postoperative acute kidney injury (AKI) in patients undergoing cardiac surgery. METHODS: We conducted a multicentre prospective observational study with propensity matching on patients treated with beta-blockers. We collected their baseline patient characteristics, comorbidities, and operative and postoperative outcomes. The endpoints were postoperative atrial fibrillation and AKI after cardiac surgery. RESULTS: Of the 1789 included patients, propensity matching led to 583 patients in each group. Maintenance of beta-blockers was not associated with a reduced risk of atrial fibrillation (odds ratio: 0.86 [95% confidence interval 0.66-1.14], P=0.335; 141 patients [24.2%] vs 126 patients [21.6%]). Sensitivity analysis did not demonstrate association between beta-blocker maintenance and atrial fibrillation after cardiac surgery (odds ratio: 0.93 [95% confidence interval: 0.72-1.22], P=0.625). Maintenance of beta-blockers was associated with a higher rate of norepinephrine use (415 [71.2%] vs 465 [79.8%], P=0.0001) and postoperative AKI (124 [21.3%] vs 159 [27.3%], P=0.0127). No statistically significant difference was observed in ICU length of stay. CONCLUSIONS: Maintenance of beta-blockers on the day of surgery was not associated with a reduced incidence of postoperative atrial fibrillation. However, maintenance of beta-blockers was associated with increased usage of vasopressors, potentially contributing to adverse postoperative renal events. CLINICAL TRIAL REGISTRATION: NCT04769752.

Clinical Effectiveness of Transversus Abdominis Plane (TAP) Block versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Laparoscopic Appendicectomy in Children: A Study Protocol for a Multicenter Double-Blind Randomized Controlled Phase III Trial.

Purpose: Postoperative pain relief after laparoscopic appendicectomy is a key determinant of early rehabilitation in children. Recent guidelines recommend performing either a transversus abdominis plane (TAP) block or local anesthesia (LA) wound infiltration as part of multimodal postoperative analgesia after appendectomy. To date, the clinical effectiveness of TAP block versus LA wound infiltration has never been compared. The hypothesis of this study is that the TAP block may provide a greater opioid-sparing effect after laparoscopic appendicectomy in children than LA wound infiltration. Study Design and Methods: We designed a multicenter double-blind randomized controlled phase III trial and aim to include 110 children who undergo laparoscopic appendicectomy. Children are randomized to receive either TAP block (TAP group) or LA wound infiltration (infiltration group). Multimodal analgesia is standardized in the two groups using the same protocol, which includes the stepwise prescription of paracetamol, phloroglucinol, ketoprofene, and nalbuphine according to the hetero-evaluation of pain performed by the nurses who were blinded to the treatment allocated using the validated FLACC scale. The primary outcome is the total dose of nalbuphine administered within 24 hours after surgery. Discussion: No study has specifically compared the clinical effectiveness of TAP block versus LA wound infiltration for postoperative pain relief after laparoscopic appendectomy in children. This paper describes the protocol for a randomized trial that addresses this issue. The results of this trial will be useful for editing guidelines with a higher level of evidence on this topic.

Prospective randomized double-blind study to evaluate the superiority of Vasopressin versus Norepinephrine in the management of the patient at renal risk undergoing cardiac surgery with cardiopulmonary bypass (NOVACC trial).

BACKGROUND: Cardiac surgery-associated acute kidney injury (CS-AKI) affects up to 30% of patients, increasing morbidity and healthcare costs. This condition results from complex factors like ischemia-reperfusion injury and renal hemodynamic changes, often exacerbated by surgical procedures. Norepinephrine, commonly used in cardiac surgeries, may heighten the risk of CS-AKI. In contrast, vasopressin, a noncatecholaminergic agent, shows potential in preserving renal function by favorably affecting renal hemodynamic. Preliminary findings, suggest vasopressin could reduce the incidence of CS-AKI compared to norepinephrine. Additionally, vasopressin is linked to a lower incidence of postoperative atrial fibrillation, another factor contributing to longer hospital stays and higher costs. This study hypothesizes that vasopressin could effectively reduce CS-AKI occurrence and severity by optimizing renal perfusion during cardiac surgeries. STUDY DESIGN: The NOVACC trial (NCT05568160) is a multicenter, randomized, double blinded superiority-controlled trial testing the superiority of vasopressin over norepinephrine in patients scheduled for cardiac surgery with cardiopulmonary bypass (CPB). The primary composite end point is the occurrence of acute kidney injury and death. The secondary end points are neurological, cardiologic, digestive, and vasopressor related complications at day 7, day 30, day 90, hospital and intensive care unit lengths of stay, medico-economic costs at day 90. CONCLUSION: The NOVACC trial will assess the effectiveness of vasopressin in cardiac surgery with CPB in reducing acute kidney injury, mortality, and medical costs. CLINICAL TRIAL REGISTRATION: NCT05568160.

Protocol Study for the Evaluation of Non-Opioid Balanced General Anaesthesia in Cardiac Surgery with Cardiopulmonary Bypass: A Randomised, Controlled, Multicentric Superiority Trial (OFACAR Study).

Opioid-free anaesthesia (OFA) is general anaesthesia based on the use of several non-opioid molecules that aim to have an analgesic effect, decrease the sympathetic response, decrease hormonal stress, and decrease the inflammatory response during surgery. Although this approach to anaesthesia is regularly used in clinical practice, it remains a novel approach. The literature on this anaesthesia modality finds a number of positive effects on cardiac, respiratory, and cognitive function but no randomised study evaluated these effects during cardiac surgery where there is a high incidence of postoperative complications. The main aim of the study is to compare OFA vs. standard balanced opioid general anaesthesia on the incidence of postoperative complications and the length of stay in intensive care and hospital. OFACAR is a multicentric, randomised, controlled, superiority, single-blind, two parallel-arm clinical trial in patients undergoing cardiac surgery with cardiopulmonary bypass. We compared a balanced general anaesthesia without opioids (OFA group) vs. a balanced opioid general anaesthesia with sufentanil (control group). One hundred and sixty patients will be enrolled in each treatment group. The primary endpoint is a composite one which corresponds to the occurrence of at least one of the postoperative complications, defined according to European standards within 30 days after surgery. Recruitment started in September 2019, and data collection is expected to end in November 2024.

Impact of early postoperative blood glucose variability on serum endocan level in cardiac surgery patients: a sub study of the ENDOLUNG observational study.

BACKGROUND: Early postoperative glycemic variability is associated with worse outcome after cardiac surgery, but the underlying mechanisms remain unknown. This study aimed to describe the relationship between postoperative glycemic variability and endothelial function, as assessed by serum endocan level in cardiac surgery patients. METHODS: We performed a post hoc analysis of patients included in the single-center observational ENDOLUNG study. Adult patients who underwent planned isolated coronary artery bypass graft surgery were eligible. Postoperative glycemic variability was assessed by calculating the coefficient of variability (CV) of blood glucose measured within 24 (CV24) and 48 (CV48) hours after surgery. Serum endocan level was measured at 24 (Endocan24) and 48 (Endocan48) hours after surgery. Pearson's correlation coefficient with 95% confidence interval (95% CI) was calculated between CV24 and Endocan24, and between CV48 and Endocan48. RESULTS: Data from 177 patients were analyzed. Median CV24 and CV48 were 18% (range 7 to 39%) and 20% (range 7 to 35%) respectively. Neither CV48 nor CV24 were significantly correlated to Endocan48 and Endocan24 respectively (r (95% CI) = 0.150 (0.001 to 0.290; and r (95% CI) = 0.080 (-0.070 to 0.220), respectively). CONCLUSIONS: Early postoperative glycemic variability within 48 h after planned cardiac surgery does not appear to be correlated with postoperative serum endocan level. CLINICAL TRIAL REGISTRATION NUMBER: NCT02542423.

Perioperative blood glucose variability and autonomic nervous system activity in on-pump cardiac surgery patients: Study protocol of a single-center observational study.

INTRODUCTION: On-pump coronary artery bypass graft (CABG) and surgical valve replacement (SVR) are high-risk procedures. Several studies reported that perioperative blood glucose (BG) variability was independently associated with impaired postoperative outcome. However, the underlying mechanisms contributing to increased perioperative BG variability and to its deleterious impact remain unknown. The hypothesis of the study is that perioperative BG variability could be related to perioperative alteration of the autonomic nervous system (ANS) activity and to preoperative BG variability. METHODS AND ANALYSIS: We designed a prospective observational single-center study. Four groups of 30 patients will be studied: group 1, including insulin-requiring type 2 diabetic patients undergoing on-pump CABG; group 2, including non-insulin-requiring type 2 diabetic patients undergoing on-pump CABG; group 3, including non-diabetic patients undergoing aortic SVR; and group 4, including non-diabetic patient undergoing on-pump CABG. Preoperative (baseline) and postoperative BG variability will be quantified using the Abbott's Freestyle Libre Pro sensor allowing for continuous subcutaneous BG monitoring. Preoperative (baseline) and postoperative ANS activity will be measured using noninvasive continuous heart rate monitoring (Mooky HR memory®). Blood level and urinary concentration of inflammatory and endothelial dysfunction biomarkers will be measured from blood and urinary samples at the end of the surgery and on postoperative day 1 and 2. The primary objective is to describe the relationship between baseline BG variability and postoperative BG variability. The secondary objectives are to describe the relationship: between baseline and postoperative BG variability according to the diabetes phenotype and to the type of surgery; between the ANS activity and the BG variability; and between postoperative BG variability and, urinary and blood biomarkers.

Clinical effectiveness of hypertonic sodium lactate infusion for intraoperative brain relaxation in patients undergoing scheduled craniotomy for supratentorial brain tumor resection: A study protocol of a single center double-blind randomized controlled phase II pilot trial.

INTRODUCTION: Hyperosmolar solutions are prescribed in neurosurgery patients to provide satisfactory intraoperative brain relaxation and to lower cerebral injuries related to surgical retractors. Mannitol is traditionally considered as the first-choice solution for brain relaxation in neurosurgery patients. Hypertonic sodium lactate infusion was reported to provide a higher and longer osmotic effect compared to mannitol in severely brain-injured patients and to prevent impaired cerebral energetics related to brain injuries. To date, the clinical effectiveness of hypertonic sodium lactate infusion has never been studied in neurosurgery patients. The hypothesis of the study is that hyperosmolar sodium lactate infusion may provide satisfactory intraoperative brain relaxation in patients undergoing scheduled craniotomy for supratentorial brain tumor resection. METHODS AND ANALYSIS: We designed a phase II randomized, controlled, double-blind, single-center pilot trial, and aim to include 50 adult patients scheduled for craniotomy for supratentorial brain tumor resection under general anesthesia. Patients will be randomized to receive either mannitol (conventional group) or hypertonic sodium lactate (intervention group) infusion at the time of skin incision. Brain relaxation (primary outcome) will be assessed immediately after opening the dura by the neurosurgeon blinded to the treatment allocated using a validated 4-point scale. The primary outcome is the proportion of satisfactory brain relaxation, defined as brain relaxation score of 3 or 4. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee (Comité de Protection des Personnes Est III) and authorized by the French Health Authority (Agence Nationale de Sécurité des Médicaments, Saint-Denis, France). The University Hospital of Besancon is the trial sponsor and the holder of all data and publication rights. Results of the study will be submitted for publication in a peer-review international medical journal and for presentation in abstract (oral or poster) in international peer-reviewed congresses. REGISTRATION: The trial is registered with ClinicalTrials.gov (Identifier: NCT04488874, principal investigator: Prof Guillaume Besch, date of registration: July 28, 2020).

Treatment of Hyperlactatemia in Acute Circulatory Failure Based on CO2-O2-Derived Indices: Study Protocol for a Prospective, Multicentric, Single, Blind, Randomized, Superiority Study (The LACTEL Study).

Background: Hyperlactatemia is a biological marker of tissue hypoperfusion with well-known diagnostic, prognostic, and therapeutic implications in shock states. In daily clinical practice, it is difficult to find out the exact mechanism underlying hyperlactatemia. Central venous to arterial CO2 difference (pCO2 gap) is a better parameter of tissue hypoperfusion than the usual ones (clinical examination and mixed venous saturation). Furthermore, the ratio between the pCO2 gap and p(v-a)CO2/C(a-v)O2 may be a promising indicator of anaerobic metabolism, allowing for the identification of different causes of tissue hypoxia and hyperlactatemia. The main aim of the study is to demonstrate that initial hemodynamic resuscitation based on an algorithm integrating the pCO2 gap and p(v-a)CO2/C(a-v)O2 ratio vs. usual clinical practice in acute circulatory failure improves lactate clearance. Methods: LACTEL is a randomized, prospective, multicentric, controlled study. It compares the treatment of hyperlactatemia using an algorithm based on the pCO2 gap and P(v-a)CO2/C(a-v)O2 ratio vs. usual clinical practice in acute circulatory failure. A total of 90 patients were enrolled in each treatment group. The primary endpoint is the number of patients with a lactate clearance of more than 10% 2 h after inclusion. Lactate levels were monitored during the first 48 h of treatment as hemodynamic parameters, biological markers of organ failure, and 28-day mortality. Discussion: pCO2 derivate indices may be of better interest than routine clinical indices to differentiate causes of hyperlactatemia and diagnose anaerobiosis. LACTEL results will provide clinical insights into the role of these indices in the early hemodynamic management of acute circulatory failure in the ICU. Clinical Trial Registration: www.clinicaltrials.gov; identifier: NCT05032521.

Continuous Transversus Abdominis Plane Infusion via Surgically Inserted Catheter for Postoperative Analgesia After Abdominal Aortic Surgery by Retroperitoneal Approach: TAPCACAO Study.

BACKGROUND: The purpose of our study was to evaluate the analgesic properties of continuous transversus abdominis plane (TAP) infusion with ropivacaine compared to placebo for postoperative analgesia in elective surgery of the abdominal aorta by retroperitoneal exposure. METHODS: We conducted a prospective, single-center, randomized, double-blind study comparing a group of patients with a TAP catheter undoing ropivacaine infusion with a placebo group. Patients received a left retroperitoneal pararectal exposure for abdominal aortic surgery. A continuous infusion catheter was placed under visual control by the surgeon before closure and removed after 48 hr. All patients had postoperative patient-controlled analgesia with morphine. The primary endpoint was morphine consumption during the first 24 hr. RESULTS: The analysis included 25 patients in the placebo group and 24 in the ropivacaine group. The average morphine consumption during the first 24 hr was significantly different, with 31 ± 16 mg in the ropivacaine group and 41 ± 17 mg in the placebo group (P = 0.019). At 48 hr, morphine consumption was still lower in the ropivacaine group (42 ± 26 mg) than in the placebo group (64 ± 25 mg) (P = 0.003). The opioid narcotic-related side effects of opioid infusion (postoperative nausea and vomiting, constipation) and length of hospital stay were similar in both populations. CONCLUSIONS: Our study showed that continuous TAP block with ropivacaine via surgically inserted catheter significantly decreased morphine consumption at 24 and 48 hr after elective abdominal aortic surgery by retroperitoneal exposure.

Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial.

BACKGROUND: The aim of the study was to investigate whether closed-loop compared to manual bispectral index (BIS)-guided target-controlled infusion of propofol and remifentanil could decrease the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery. METHODS: Patients aged >50 admitted for elective major noncardiac surgery were included in a single-blind randomized (ratio 2:1) trial. The anesthetic protocol was allocated by randomization into either closed-loop or manual BIS-guided propofol and remifentanil titration. The BIS target range was 40-60. All patients had cognitive assessment the day before surgery and within 72 hours after surgery using a battery of neuropsychological tests. The primary outcome was the rate of postoperative neurocognitive disorders. Postoperative neurocognitive disorders were defined as a decrease >20% from baseline on at least 3 scores. Intergroup comparison of the primary outcome was performed using the χ2 test. RESULTS: A total of 143 and 61 patients were included in the closed-loop and manual groups, respectively (age: 66 [8] vs 66 [9] years). The primary outcome was observed in 18 (13%) and 10 (16%) patients of the closed-loop and manual groups, respectively (relative risk [95% confidence interval {CI}], 0.77 [0.38-1.57], P = .47). Intraoperative propofol consumption was lower (4.7 [1.4] vs 5.7 [1.4] mg·kg-1·h-1, mean difference [MD] [95% CI], -0.73 [-0.98 to -0.48], P < .0001) and the proportion of time within the BIS target range higher (84 [77-89] vs 74 [54-81]%, MD [95% CI], 0.94 [0.67-1.21], P < .0001) in the closed-loop group. CONCLUSIONS: Closed-loop compared to manual BIS-guided total intravenous anesthesia provided a significant reduction in episodes of an excessive depth of anesthesia while decreasing intraoperative propofol requirement but no evidence for a reduction of the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery was observed.

Quality of life 10 years after cardiac surgery in adults: a long-term follow-up study.

BACKGROUND: Quality of life (QoL) is a multifactorial concept that assesses physical and mental health. We prospectively studied the quality of life of patients undergoing coronary artery bypass graft (CABG) surgery using the Short-Form 36-item questionnaire (SF-36) up to 10 years after surgery. METHODS: Between January 2000 and December 2002, all patients undergoing elective isolated CABG in the cardiac & thoracic surgery department of a large university hospital in Eastern France underwent initial QoL evaluation with the SF-36. The same questionnaire was mailed to every patient annually (± 2 weeks around the date of surgery) up to 10 years after their operation. We recorded socio-demographic and clinical variables at inclusion. Predictors of impaired QoL at 10 years were identified by logistic regression. RESULTS: A total of 272 patients (213 men, 59 women) were enrolled; mean age at inclusion was 65 ± 10 years. At 10 years post-surgery, 81 patients had died (29.7%). The physical component summary (PCS) score was significantly higher at 5 years after surgery than at baseline (p < 0.01), and significantly lower at 10 years than at 5 years (p < 0.01), although there remained a significant difference between 10-year PCS and baseline score (p = 0.004). The mental component summary (MCS) score was significantly higher at 5 years than at the time of surgery (p < 0.001), and remained significantly higher compared to baseline at 10 years after surgery (p = 0.010). By multivariate analysis, diabetes and dypsnea were both associated with worse PCS at 10 years, while lower age was associated with better 10-year PCS. Only diabetes was associated with impaired MCS at 10 years. CONCLUSIONS: Cardiac surgery appears to durably and positively affect both physical and mental components of quality of life.

Prevalence and Impact of Malnutrition in Patients Surgically Treated for Chronic Mesenteric Ischemia.

BACKGROUND: Patients suffering from chronic mesenteric ischemia are at risk of malnutrition due to the fear of food and weight loss. However, the impact of malnutrition on the morbidity and mortality at the time of surgery is not studied extensively, just as its prevalence. The main objective of this study was to evaluate the influence of malnutrition on the survival of the patients operated for chronic mesenteric ischemia. The secondary objectives were to evaluate the prevalence of malnutrition in this population and to evaluate the early complications after surgery according to the nutritional condition of the patients. METHODS: We conducted a monocentric retrospective observational study including consecutively all the patients operated for chronic mesenteric ischemia between 2005 and 2016. The nutritional status was determined a posteriori according to the criteria of the French High Health Authority using body mass index, the percentage of weight loss, and albumin. We thus divided the patients into 2 groups, "malnourished" and "non-malnourished." We compared the survival of the patients of the 2 groups with a log-rank test. RESULTS: We enrolled 54 patients including 35 men (65%), with a mean age of 68.1 years (±12.3). The prevalence of malnutrition was 70% (38 patients), including 9 severely malnourished patients (23.6%). Twenty-nine patients (53.7%) were treated by endovascular technique, and twenty-five had conventional surgery (46.3%). The type of management was not different between the 2 groups: 20 patients of the malnourished group (52.6%) and 9 patients of the non-malnourished group (56.3%) were treated by endovascular technique (P = 0.8). The 30-day mortality was null in the non-malnourished group, whereas ten patients (26.3%) died in the malnourished group (P = 0.02). The short-term complications were not significantly different between the malnourished and the non-malnourished groups (37% vs. 19%, P = 0.32). The mean duration of follow-up was 639 days (±660). The 3-year survival was not different between the endovascular group and the open surgery group (43% vs. 52%, P = 0.7). The 3-year survival was statistically higher in the non-malnourished group (87%) than in the malnourished group (49.6%) (P = 0.01). CONCLUSIONS: In our experience, preoperative malnutrition is a factor significantly decreasing the survival of the patients treated with open surgery or with endovascular technique for chronic mesenteric ischemia. A more optimal preoperative management of this malnutrition could improve the results of these procedures.

Impact of post-procedural glycemic variability on cardiovascular morbidity and mortality after transcatheter aortic valve implantation: a post hoc cohort analysis.

BACKGROUND: Glycemic variability is associated with worse outcomes after cardiac surgery, but the prognosis value of early glycemic variability after transcatheter aortic valve implantation is not known. This study was therefore designed to analyze the prognosis significance of post-procedural glycemic variability within 30 days after transcatheter aortic valve implantation. METHODS: A post hoc analysis of patients from our center included in the FRANCE and FRANCE-2 registries was conducted. Post-procedural glycemic variability was assessed by calculating the mean daily δ blood glucose during the first 2 days after transcatheter aortic valve implantation. Major complications within 30 days were death, stroke, myocardial infarction, acute heart failure, and life-threatening cardiac arrhythmias. RESULTS: We analyzed 160 patients (age (median [interquartile] = 84 [80-88] years; diabetes mellitus (n) = 41 (26%) patients; logistic Euroscore = 20 [12-32]). The median value of mean daily δ blood glucose was 4.3 mmol l-1. The rate of major complications within 30 days after procedure among patients with the lowest quartile of glycemic variability was 12%, increasing from 12 to 26%, and 39% in the second, third, and fourth quartiles, respectively. In multivariate analysis, glycemic variability was independently associated with an increased risk of major complications within 30 days after the procedure (odds ratio [95% CI] = 1.83 [1.19-2.83]; p = 0.006). CONCLUSIONS: This study showed that post-procedural glycemic variability was associated with an increased risk of major complications within 30 days after transcatheter aortic valve implantation. Trial registration Clinical trial registration number https://www.clinicaltrials.gov/ ; identifier: NCT02726958; date: April 4th, 2016.

Evolution of Practices in Treatment of Abdominal Aortic Aneurysm in France between 2006 and 2015.

BACKGROUND: The main objective of this study was to identify the changes that have occurred in the treatment of abdominal aortic aneurysms (AAA) in France over a period of 10 years. MATERIALS AND METHODS: Comprehensive data for AAA surgical activity from all French health establishments between 2006 and 2015 were collected from the records of the "Agence Technique de l'Information sur l'Hospitalisation." Based on the common classification of medical procedures, our research was conducted on surgical procedures involving open and endovascular surgical treatment of AAA. A year-by-year descriptive analysis was completed for the number of procedures, the change in the type of surgery performed in each type of institution, and the mean duration of hospital stays. RESULTS: During the study period, the number of AAA treated increased overall by 28.2% (from 6,412 procedures in 2006 to 8,221 in 2015). The proportion of endovascular procedures increased in this period (from 27.0% in 2006 to 68.5% in 2015) like their number from 1,735 to 5,632. The number of fenestrated endovascular aneurysm repair (listed since 2013) increased from 251 to 373 in 3 years. Open repair decreased from 4,677 interventions in 2006 to 2,589 in 2015 with higher proportion of suprarenal clamping in open surgery (from 23% in 2006 to 40% in 2015). The number of ruptured AAA treated in open surgery remained stable over this period (473 in 2006 and 462 in 2015). CONCLUSIONS: In France, the number of AAA operated between 2006 and 2015 increased by 28.2%. There was a significant increase in endovascular techniques, which became largely predominant in 2015. In open repair, the proportion of complex procedures increased in this period. However, this transformation, which is in line with current recommendations and major publications, needs to be reassessed in the long term.

Clinical effectiveness of single dose of intravenous dexamethasone on the duration of ropivacaine axillary brachial plexus block: the randomized placebo-controlled ADEXA trial.

BACKGROUND AND OBJECTIVES: The effect of intravenous dexamethasone on the duration of axillary plexus block performed using ropivacaine is not described. The aim of this study is to assess the effect of intravenous dexamethasone on the duration of axillary plexus block analgesia after distal upper arm surgery. METHODS: In this prospective, randomized, placebo-controlled, double-blinded trial, consenting patients scheduled for hand or forearm surgery under ultrasound-guided axillary plexus block performed using 0.5 mL/kg of 0.475% ropivacaine, were randomized to receive an intravenous injection of either 8 mg/2 mL of dexamethasone (Dexa group) or 2 mL of saline (Control). The primary outcome was the time of first analgesic intake after axillary block. Secondary outcomes included motor or sensory block duration, total use of postoperative analgesics, and block-related complications. RESULTS: Among the 98 patients included, 6 and 2 patients did not require postoperative analgesic intake in Dexa and Control groups, respectively (p=0.06). The time of first analgesic intake was significantly longer in the Dexa (20.9±9.3 hours) than in the Control group (14.7±6.6 hours, p<0.0004). Motor and sensory recovery occurred significantly later, and total analgesic consumption was lower in the Dexa than in the Control group. No nerve complication related to intravenous dexamethasone injection was recorded. CONCLUSIONS: This study showed that intravenous dexamethasone delayed for 6 hours the time to first analgesic intake after upper arm surgery under axillary plexus block performed with the long-lasting local anesthetic ropivacaine. This suggests that intravenous dexamethasone could be an interesting adjuvant to axillary plexus block. TRIAL REGISTRATION NUMBER: NCT02862327.

Impact of intravenous exenatide infusion for perioperative blood glucose control on myocardial ischemia-reperfusion injuries after coronary artery bypass graft surgery: sub study of the phase II/III ExSTRESS randomized trial.

BACKGROUND: The aim of the study was to investigate whether intravenous (iv) infusion of exenatide, a synthetic GLP-1 receptor agonist, could provide a protective effect against myocardial ischemia-reperfusion injury after coronary artery bypass graft (CABG) surgery. METHODS: A sub study analysis of patients > 18 years admitted for elective CABG and included in the ExSTRESS trial was conducted. Patients were randomized to receive either iv exenatide (1-h bolus of 0.05 µg min-1 followed by a constant infusion of 0.025 µg min-1) (exenatide group) or iv insulin therapy (control group) for blood glucose control (target range 100-139 mg dl-1) during the first 48 h after surgical incision. All serum levels of troponin I measured during routine care in the Cardiac Surgery ICU were recorded. The primary outcome was the highest value of plasma concentration of troponin I measured between 12 and 24 h after ICU admission. The proportion of patients presenting an echocardiographic left ventricular ejection fraction (LVEF) > 50% at the follow-up consultation was compared between the two groups. RESULTS: Finally, 43 and 49 patients were analyzed in the control and exenatide groups, respectively {age: 69 [61-76] versus 71 [63-75] years; baseline LVEF < 50%: 6 (14%) versus 16 (32%) patients; on-pump surgery: 29 (67%) versus 33 (67%) patients}. The primary outcome did not significantly differ between the two groups (3.34 [1.06-6.19] µg l-1 versus 2.64 [1.29-3.85] µg l-1 in the control and exenatide groups, respectively; mean difference (MD) [95% confidence interval (95% CI)] 0.16 [- 0.25; 0.57], p = 0.54). The highest troponin value measured during the first 72 h in the ICU was 6.34 [1.36-10.90] versus 5.04 [2.39-7.18] µg l-1, in the control and exenatide groups respectively (MD [95% CI] 0.20 [- 0.22; 0.61], p = 0.39). At the follow-up consultation, 5 (12%) versus 8 (16%) patients presented a LVEF < 50% in the control and in the exenatide groups respectively (relative risk [95% CI] 0.68 [0.16; 2.59], p = 0.56). CONCLUSIONS: Postoperative iv exenatide did not provide any additional cardioprotective effect compared to iv insulin in low-risk patients undergoing scheduled CABG surgery. Trial registration ClinicalTrials.gov Identifier NCT01969149, date of registration: January 7th, 2015; EudraCT No. 2009-009254-25 A, date of registration: January 6th, 2009.

Early post-operative cognitive dysfunction after closed-loop versus manual target controlled-infusion of propofol and remifentanil in patients undergoing elective major non-cardiac surgery: Protocol of the randomized controlled single-blind POCD-ELA trial.

INTRODUCTION: Post-operative cognitive dysfunction (POCD) is frequent in patients older than 60 years undergoing major non-cardiac surgery, and increases both morbidity and mortality. Anesthetic drugs may exert neurotoxic effects and contribute to the genesis of POCD. The hypothesis of the POCD-ELA trial was that closed-loop target-controlled infusion of propofol and remifentanil could reduce the occurrence of POCD by decreasing the risk of excessive depth of anesthesia and the dose of anesthetic drugs. METHODS AND ANALYSIS: We designed a single-center, single-blind, randomized, controlled, parallel trial and aim to include 204 patients aged >60 years undergoing elective major non-cardiac surgery. Patients will be randomized to receive closed-loop versus manual target-controlled infusion of propofol and remifentanil guided by bispectral index monitoring. Cognitive assessment will be performed the day before surgery (baseline) and within 72 hours after surgery, using a battery of validated neuropsychological tests. The primary outcome is the incidence of POCD within 72 hours after surgery. POCD is defined as a Z-score value > 1.96 for at least 2 different tests or a Z-score composite value >1.96. The calculation of the Z-score is based on data from an age-matched control population who did not undergo surgery or general anesthesia. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee (Comité de Protection des Personnes Est-II) and authorized by the French Health Products Agency (Agence Nationale de Sécurité des Médicaments, Saint-Denis, France). The University Hospital of Besancon is the trial sponsor and the holder of all data and publication rights. Results of the study will be submitted for publication in a peer-review international medical journal and for presentation in abstract (oral or poster) in international peer-reviewed congresses. REGISTRATION: The trial is registered with ClinicalTrials.gov (Identifier: NCT02841423, principal investigator: Prof Emmanuel Samain, date of registration: July 22, 2016). Last amendment of protocol: version 8.0 April 2018.

Abdominal compartment syndrome and ruptured aortic aneurysm: Validation of a predictive test (SCA-AAR).

BACKGROUND: The abdominal compartment syndrome (ACS) has been clearly identified as being one of the main causes of mortality after ruptured abdominal aortic aneurysm (rAAA). The ACS is defined as a sustained intra-abdominal pressure > 20 mm Hg associated with a new organ dysfunction or failure. A pilot study was conducted and found that the threshold of 3 among 8 selected criteria, we would predict an ACS occurrence with a 54% positive predictive value and a 92% negative predictive value. But a multicentric prospective study was clearly needed to confirm these results. The outcome of this new study is to assess the qualities of a predictive test on occurrence of the ACS after rAAA surgery. METHODS: This is a 30 months prospective cohort study conducted in 12 centers and 165 patients will be included. All patients with a rAAA will be consecutively included, whatever the surgical treatment. At the end of surgery, all patients have an abdominal closure and a monitoring of intrabladder pressure will be established every 3 to 4 hours. Decompressive laparotomy will be indicated when ACS occurs. Follow-up period is 1 month. Eight pre- and per-operative criteria will be studied: anemia, hypotension, cardiac arrest, obesity, massive fluid resuscitation, transfusion, hypothermia, and acidosis. DISCUSSION: In the literature, there is no recommendation about prophylactic decompression, but early decompressive laparotomy appears to improve survival. This study should make it possible to establish a predictive test, detect the ACS early, and consider a prophylactic decompression in the operating room. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02859662, Registered on 4 August 2016.

Long-term compliance with a validated intravenous insulin therapy protocol in cardiac surgery patients: a quality improvement project.

QUALITY PROBLEM: Safe and efficient blood glucose (BG) level control after cardiac surgery relies on an intensive care unit (ICU) team-based approach, including implementation of a dynamic insulin therapy protocol (ITP). Long-term compliance with such a complex protocol is poorly addressed in the literature. The aim of this study was to assess the long-term compliance of nurses with the ITP, 7 years after its implementation in the ICU. INITIAL ASSESSMENT: A professional practice evaluation, integrated in a process of quality improvement program, was retrospectively conducted on 224 consecutive cardiac surgery patients over a 6-month period (PHASE 1). The timing of BG measurements and the insulin infusion rate adjustments (primary endpoints) were correctly performed according to protocol requirements in 35 and 53% of the cases, respectively. CHOICE OF SOLUTION AND IMPLEMENTATION: After systemic analysis of the causes of protocol deviations, four corrective measures aiming at improving both physician and nurse adherence to the protocol were implemented in the ICU. EVALUATION: Evaluation of 104 patients in PHASE 2 showed a significant improvement in both the timing of BG measurements (83 %, P < 0.001 vs. PHASE 1), and insulin infusion rate adjustments (76%, P < 0.001). LESSONS LEARNED: Seven years after the implementation of a dynamic insulin infusion protocol, major protocol deviations were observed. Identification of several causes after a professional practice evaluation and the implementation of simple corrective measures restored a high level of nurse compliance.