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.

Goal-Directed Fluid Therapy and major postoperative complications in elective craniotomy. A retrospective analysis of a before-after multicentric study.

BACKGROUND: Goal-Directed Fluid Therapy (GDFT) is recommended to decrease major postoperative complications. However, data are lacking in intra-cranial neurosurgery. METHODS: We evaluated the efficacy of a GDFT protocol in a before/after multi-centre study in patients undergoing elective intra-cranial surgery for brain tumour. Data were collected during 6 months in each period (before/after). GDFT was performed in high-risk patients: ASA score III/IV and/or preoperative Glasgow Coma Score (GCS) < 15 and/or history of brain tumour surgery and/or tumour greater size ≥ 35 mm and/or mid-line shift ≥ 3 mm and/or significant haemorrhagic risk. Major postoperative complication was a composite endpoint: re-intubation after surgery, a new onset of GCS < 15 after surgery, focal motor deficit, agitation, seizures, intra-cranial haemorrhage, stroke, intra-cranial hypertension, hospital-acquired related pneumonia, surgical site infection, cardiac arrythmia, invasive mechanical ventilation ≥ 48 h and in-hospital mortality. RESULTS: From July 2018 to January 2021, 344 patients were included in 3 centers: 171 in the before and 173 in the after (GDFT) period. Thirty-six (21.1%) patients displayed a major postoperative complication in the Before period, and 50 (28.9%) in the After period (p = 0.1). In the propensity score analysis, we matched 48 patients in each period: 9 (18.8%) patients in the After period and 14 (29.2%) patients in the Before period displayed a major perioperative complication (p = 0.2). Sixty-two (35.8%) patients received GDFT in the After period, with great heterogeneity among centers (p < 0.05). CONCLUSIONS: In our before-after study, GDFT was not associated with a decrease in postoperative major complications in elective intra-cranial neurosurgery.

Prediction Score for Postoperative Neurologic Complications after Brain Tumor Craniotomy: A Multicenter Observational Study.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Craniotomy for brain tumor displays significant morbidity and mortality, and no score is available to discriminate high-risk patients. Our objective was to validate a prediction score for postoperative neurosurgical complications in this setting. METHODS: Creation of a score in a learning cohort from a prospective specific database of 1,094 patients undergoing elective brain tumor craniotomy in one center from 2008 to 2012. The validation cohort was validated in a prospective multicenter independent cohort of 830 patients from 2013 to 2015 in six university hospitals in France. The primary outcome variable was postoperative neurologic complications requiring in-intensive care unit management (intracranial hypertension, intracranial bleeding, status epilepticus, respiratory failure, impaired consciousness, unexpected motor deficit). The least absolute shrinkage and selection operator method was used for potential risk factor selection with logistic regression. RESULTS: Severe complications occurred in 125 (11.4%) and 90 (10.8%) patients in the learning and validation cohorts, respectively. The independent risk factors for severe complications were related to the patient (Glasgow Coma Score before surgery at or below 14, history of brain tumor surgery), tumor characteristics (greatest diameter, cerebral midline shift at least 3 mm), and perioperative management (transfusion of blood products, maximum and minimal systolic arterial pressure, duration of surgery). The positive predictive value of the score at or below 3% was 12.1%, and the negative predictive value was 100% in the learning cohort. In-intensive care unit mortality was observed in eight (0.7%) and six (0.7%) patients in the learning and validation cohorts, respectively. CONCLUSIONS: The validation of prediction scores is the first step toward on-demand intensive care unit admission. Further research is needed to improve the score's performance before routine use.

Randomised comparison of Enk™ and Manujet™ for emergency tracheal oxygenation with a high-fidelity full-scale simulation.

BACKGROUND: We aimed to compare time and difficulties of emergency tracheal oxygenation with Enk™ or Manujet™ by anaesthesiologists or intensivists, in a full-scale cannot ventilate and intubate scenarios on a SimMan3G™ high-fidelity patient simulator. METHODS: After ethical committee approval and written informed consent, teams (two to three learners with at least one physician senior) participating at a difficult airway training with a massive sublingual haematoma scenario, were randomised in Enk™ (E) group (29 teams, 76 learners) and Manujet™ (M) group (31 teams, 84 learners) according to the device at disposal. Main criterion was time between taking device in hand and first insufflation delay. Data were medians [25-75%]. RESULTS: The handling-insufflation time was shorter with Enk™ than with Manujet™ (74 [54-87] seconds versus 95 [73-123] seconds (s), P=0.0112). The team number performing insufflation within one minute after device handling was higher in the E group (8, 27.6%) than in the M group (2, 6.4%) (P=0.0392) as well as the team number performing insufflation within 90s in the E group (22, 75.09%) than in the M group (12, 38.7%) (P=0.0047). In E group, 75% of learners reported no difficulty versus 58.8% in M group (P=0.0443). Insufflation frequency was high in both groups and higher than 12min-1 in 51.7% of the teams. CONCLUSION: In a simulation context, Enk™ use is faster and easier. A high insufflation rate was also in favour of Enk™ that generates lower airway pressures.