Continuation vs Discontinuation of Renin-Angiotensin System Inhibitors Before Major Noncardiac Surgery: The Stop-or-Not Randomized Clinical Trial.

Importance: Before surgery, the best strategy for managing patients who are taking renin-angiotensin system inhibitors (RASIs) (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) is unknown. The lack of evidence leads to conflicting guidelines. Objective: To evaluate whether a continuation strategy vs a discontinuation strategy of RASIs before major noncardiac surgery results in decreased complications at 28 days after surgery. Design, Setting, and Participants: Randomized clinical trial that included patients who were being treated with a RASI for at least 3 months and were scheduled to undergo a major noncardiac surgery between January 2018 and April 2023 at 40 hospitals in France. Intervention: Patients were randomized to continue use of RASIs (n = 1107) until the day of surgery or to discontinue use of RASIs 48 hours prior to surgery (ie, they would take the last dose 3 days before surgery) (n = 1115). Main Outcomes and Measures: The primary outcome was a composite of all-cause mortality and major postoperative complications within 28 days after surgery. The key secondary outcomes were episodes of hypotension during surgery, acute kidney injury, postoperative organ failure, and length of stay in the hospital and intensive care unit during the 28 days after surgery. Results: Of the 2222 patients (mean age, 67 years [SD, 10 years]; 65% were male), 46% were being treated with angiotensin-converting enzyme inhibitors at baseline and 54% were being treated with angiotensin receptor blockers. The rate of all-cause mortality and major postoperative complications was 22% (245 of 1115 patients) in the RASI discontinuation group and 22% (247 of 1107 patients) in the RASI continuation group (risk ratio, 1.02 [95% CI, 0.87-1.19]; P = .85). Episodes of hypotension during surgery occurred in 41% of the patients in the RASI discontinuation group and in 54% of the patients in the RASI continuation group (risk ratio, 1.31 [95% CI, 1.19-1.44]). There were no other differences in the trial outcomes. Conclusions and Relevance: Among patients who underwent major noncardiac surgery, a continuation strategy of RASIs before surgery was not associated with a higher rate of postoperative complications than a discontinuation strategy. Trial Registration: ClinicalTrials.gov Identifier: NCT03374449.

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).

Prospective evaluation of early functional recovery of displaced fractures of the middle third of the clavicle whether operated or not.

INTRODUCTION: Several studies have analyzed the functional recovery after plate fixation of a displaced fracture of the middle third of the clavicle beyond the 6th week. The aim of this study was to assess the early functional recovery in the first 6 weeks, which has not yet been investigated. HYPOTHESIS: Functional recovery in the first 6 weeks after surgical treatment is better than in the first 6 weeks of functional (non-operative) treatment. METHODS: Any patient who had a closed displaced fracture of the middle third of the clavicle - Edinburgh types 2B1 or 2B2 - was informed of the treatment options within a week of their fracture: surgical fixation by anatomic plate or functional treatment. A QuickDASH score was filled out weekly for 6 weeks and at 3 and 6 months. Similarly, the Constant score was determined at 3 and 6 weeks and at 3 and 6 months. Any complications were documented and time to union was determined. RESULTS: Sixty-five fractures in 65 patients were followed for 6 months. Twenty-six patients chose surgical treatment (S) and 39 chose functional treatment (F). The Constant and QuickDASH scores were significantly better in the S group from the 2nd to the 6th week. At 3 weeks, we found a Constant score of 57.7 in group F versus 74.9 in group S (p<0.01) and a QuickDASH of 55.9 in group F versus 27.4 in group S (p<0.001). At 6 weeks, the Constant score was 71.3 versus 86.1 (p<0.001) and the QuickDASH was 28.3 versus 10.6 (p<0.01), respectively. At 3 and 6 months, the recovery was comparable in both groups for these two scores. Return to work was earlier in the S group (34.3 versus 59.7 days; p<0.05). DISCUSSION: This is the first study reporting the functional results during the first 6 weeks after a displaced fracture of the middle third of the clavicle in adults. Further studies should be conducted to better identify target patients for whom fracture fixation may be beneficial. CONCLUSION: This study supports open reduction and internal fixation with an anatomical plate of displaced fractures of the middle third of the clavicle since the functional recovery is better in the first 6 weeks. LEVEL OF EVIDENCE: III; prospective case-control study.

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.

Perioperative management of patients with coronary artery disease undergoing non-cardiac surgery: Summary from the French Society of Anaesthesia and Intensive Care Medicine 2017 convention.

This review summarises the specific stakes of preoperative, intraoperative, and postoperative periods of patients with coronary artery disease undergoing non-cardiac surgery. All practitioners involved in the perioperative management of such high cardiac risk patients should be aware of the modern concepts expected to decrease major adverse cardiac events and improve short- and long-term outcomes. A multidisciplinary approach via a functional heart team including anaesthesiologists, cardiologists and surgeons must be encouraged. Rational and algorithm-guided management of those patients should be known and implemented from preoperative to postoperative period.

Ultrasound guidance of needle tip position for femoral nerve blockade: an observational study.

BACKGROUND: The femoral nerve lies in the ilio-fascial space in a groove formed by the iliac and psoas muscles (GIPM) posteriorly, and overlaid by the iliac fascia. Recommendations for needle insertion for femoral blockade using ultrasound imaging are to insert the needle tip behind the iliac fascia at the lateral side of the femoral nerve, but this part of the nerve is poorly visualised in some patients. A more accurate location of the lateral part of the femoral nerve might be achieved by identifying the GIPM and its lateral segment. OBJECTIVES: The objectives of this study are to determine the frequency of ultrasound visibility of the lateral part of the femoral nerve and GIPM, and to note the motor response to electrostimulation of the nerve and the spread of local anaesthetic when positioning the needle tip at the lateral segment of the GIPM. DESIGN: A prospective observational (case series) study. SETTING: Department of Anaesthesiology of a University Hospital. PATIENTS: Inpatients undergoing hip or knee surgery scheduled to have femoral nerve blockade were eligible to participate. INTERVENTIONS: The ultrasound probe was positioned in the inguinal region, and direct ultrasound identification of the femoral nerve, lying on the GIPM behind the iliac fascia, was obtained. A stimulating needle, inserted in-plane and advanced lateral to medial was directed towards the femoral nerve until it made contact with the target structure defined as the lateral segment of the GIPM. MAIN OUTCOME MEASURE: Ultrasound identification of the lateral part of the femoral nerve and GIPM. RESULTS: An image compatible with the lateral part of the femoral nerve was observed in 91 out of 100 patients. In the remaining nine patients, when the lateral part of the femoral nerve was not seen, GIPM could be visualised in five (55%) patients. The iliac fascia and GIPM were clearly visualised in 68 and 85 patients respectively. In 85 cases when the needle tip was placed at the lateral segment of GIPM, a quadriceps femoris muscle motor response was obtained, and the distribution of the anaesthetic solution was observed behind the iliac fascia in all patients. In two patients, only the iliac fascia was identified, and in the two patients, none of these structures was correctly visualised. CONCLUSION: The GIPM was seen in the majority undergoing ultrasound-guided femoral nerve blockade, even when the lateral part of the femoral nerve was not visualised. Using the lateral segment of GIPM as a target for needle tip location in an in-plane lateral to medial approach of the femoral nerve deserves further investigation.