The choice of perioperative inotropic support impacts the outcome of small infants undergoing complex cardiac surgery: an observational study.

BACKGROUND: Vaso-inotropic agents are frequently used to prevent and/or treat low cardiac output syndrome in infants undergoing surgery for congenital heart disease. Due to the lack of comparative studies, their use is largely dependent on physician- and center preferences. The aim was to assess the impact of two different inotropic regimens, milrinone-epinephrine versus dobutamine on postoperative morbi-mortality in young children undergoing complex cardiac surgery. METHODS: All consecutive children younger than one year of age admitted for complex cardiac surgery (Risk Adjustment in Congenital Heart Surgery-1 [RACHS-1] score ≥3) with cardiopulmonary bypass (CPB) from January 2008 to December 2018 were included. Children received either milrinone in association with low dose epinephrine (milrinone-epinephrine group) or dobutamine (dobutamine group) groups were matched and compared using a propensity score. Our primary outcome was a composite measure including either hospital death and/or the presence of at least two of the following events: respiratory failure, prolonged inotropic support, or renal failure. RESULTS: Two hundred and fifty patients were included in the analysis. Children in the milrinone-epinephrine group (N.=184) suffered more frequently from a cyanotic heart disease and had longer surgery, CPB, and aortic cross clamp times than those in the dobutamine group (N.=66). After matching, children in the milrinone-epinephrine group had a higher incidence of severe postoperative morbidity or mortality compared to those in the dobutamine group (27.4 versus 13.9%; P=0.016). Respiratory failure (28% vs. 12%), prolonged inotropic support (71% vs. 35%) and in-hospital death (3 vs. 0%) were more frequent in the milrinone-epinephrine group. CONCLUSIONS: In young infants undergoing complex cardiac surgery, milrinone combined with epinephrine is associated with a higher incidence of postoperative morbidity or mortality compared to dobutamine for perioperative inotropic support. Further prospective randomized studies are required to confirm this finding.

Prospective, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial comparing the safety and efficacy of intranasal dexmedetomidine to oral midazolam as premedication for propofol sedation in pediatric patients undergoing magnetic resonance imaging: the MIDEX MRI trial.

BACKGROUND: Children under 6 years who need magnetic resonance imaging usually require sedation to obtain best quality images, but the optimal sedation protocol remains to be determined. In 2018, we showed a 22% interruption in image acquisition during magnetic resonance imaging when performing a propofol-based sedation using a bolus approach. As non-pharmacological premedication is often insufficient to reduce the anxiety of children related to parental separation, pharmacological premedication may be useful to facilitate the induction of anesthesia. In our institution, effective premedication is obtained oral intake of midazolam, though its administration relies on patients' compliance and could also lead to paradoxical reaction. Dexmedetomidine has a safe profile in the pediatric population and can therefore represent an interesting alternative. The primary objective of this trial is to demonstrate the superiority of intranasal dexmedetomidine compared to oral midazolam as premedication in reducing the occurrence of any event requiring temporary or definitive interruption of the examination to allow anesthesiologist intervention in children undergoing magnetic resonance imaging under propofol sedation. METHODS: In this single-center, prospective, randomized, double-blind, double-dummy, active comparator-controlled, superiority trial, we planned to include 250 patients, aged 6 months to 6 years, undergoing a scheduled magnetic resonance imaging requiring the presence of an anesthesiologist. After informed consent, the patients will be randomized to receive either oral midazolam or intranasal dexmedetomidine as premedication. The data will be analyzed in intention to treat, using Kolmogorov-Smirnov Z, chi-square, Wilcoxon, and Mann-Whitney U tests. A P-value < 0.05 will be considered statistically significant. DISCUSSION: The MIDEX MRI study will assess the efficacy of intranasal dexmedetomidine compared to oral midazolam to improve the quality of a propofol-based sedation prior to magnetic resonance imaging, without negative repercussion on the postoperative period. TRIAL REGISTRATION: ClinicalTrial.gov NCT05192629 . Registered on 14 January 2022. Protocol version 2.1.

Hypotension-Avoidance Versus Hypertension-Avoidance Strategies in Noncardiac Surgery : An International Randomized Controlled Trial.

BACKGROUND: Among patients having noncardiac surgery, perioperative hemodynamic abnormalities are associated with vascular complications. Uncertainty remains about what intraoperative blood pressure to target and how to manage long-term antihypertensive medications perioperatively. OBJECTIVE: To compare the effects of a hypotension-avoidance and a hypertension-avoidance strategy on major vascular complications after noncardiac surgery. DESIGN: Partial factorial randomized trial of 2 perioperative blood pressure management strategies (reported here) and tranexamic acid versus placebo. (ClinicalTrials.gov: NCT03505723). SETTING: 110 hospitals in 22 countries. PATIENTS: 7490 patients having noncardiac surgery who were at risk for vascular complications and were receiving 1 or more long-term antihypertensive medications. INTERVENTION: In the hypotension-avoidance strategy group, the intraoperative mean arterial pressure target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld and the other long-term antihypertensive medications were administered only for systolic blood pressures 130 mm Hg or greater, following an algorithm. In the hypertension-avoidance strategy group, the intraoperative mean arterial pressure target was 60 mm Hg or greater; all antihypertensive medications were continued before and after surgery. MEASUREMENTS: The primary outcome was a composite of vascular death and nonfatal myocardial injury after noncardiac surgery, stroke, and cardiac arrest at 30 days. Outcome adjudicators were masked to treatment assignment. RESULTS: The primary outcome occurred in 520 of 3742 patients (13.9%) in the hypotension-avoidance group and in 524 of 3748 patients (14.0%) in the hypertension-avoidance group (hazard ratio, 0.99 [95% CI, 0.88 to 1.12]; P = 0.92). Results were consistent for patients who used 1 or more than 1 antihypertensive medication in the long term. LIMITATION: Adherence to the assigned strategies was suboptimal; however, results were consistent across different adherence levels. CONCLUSION: In patients having noncardiac surgery, our hypotension-avoidance and hypertension-avoidance strategies resulted in a similar incidence of major vascular complications. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research, National Health and Medical Research Council (Australia), and Research Grant Council of Hong Kong.

Jet Ventilation Reduces Coronary Sinus Movement in Patients Undergoing Atrial Fibrillation Ablation: An Observational Crossover Study.

BACKGROUND: One of the reasons that high-frequency jet ventilation (HFJV) is used is due to the near immobility of thoracic structures. However, no study has quantified the movements of cardiac structures during HFJV compared with normal mechanical ventilation. METHODS: After ethical approval and written informed consent, we included 21 patients scheduled for atrial fibrillation ablation in this prospective crossover study. Each patient was ventilated with both normal mechanical ventilation and HFJV. During each ventilation mode, displacements of the cardiac structure were measured by the EnSite Precision mapping system using a catheter placed in the coronary sinus. RESULTS: The median [Q1-Q4] displacement was 2.0 [0.6-2.8] mm during HFJV and 10.5 [9.3-13.0] mm during conventional ventilation (p < 0.000001). CONCLUSION: This study quantifies the minimal movement of cardiac structures during HFJV compared to standard mechanical ventilation.

Detection of Motor Cerebral Activity After Median Nerve Stimulation During General Anesthesia (STIM-MOTANA): Protocol for a Prospective Interventional Study.

BACKGROUND: Accidental awareness during general anesthesia (AAGA) is defined as an unexpected awareness of the patient during general anesthesia. This phenomenon occurs in 1%-2% of high-risk practice patients and can cause physical suffering and psychological after-effects, called posttraumatic stress disorder. In fact, no monitoring techniques are satisfactory enough to effectively prevent AAGA; therefore, new alternatives are needed. Because the first reflex for a patient during an AAGA is to move, but cannot do so because of the neuromuscular blockers, we believe that it is possible to design a brain-computer interface (BCI) based on the detection of movement intention to warn the anesthetist. To do this, we propose to describe and detect the changes in terms of motor cortex oscillations during general anesthesia with propofol, while a median nerve stimulation is performed. We believe that our results could enable the design of a BCI based on median nerve stimulation, which could prevent AAGA. OBJECTIVE: To our knowledge, no published studies have investigated the detection of electroencephalographic (EEG) patterns in relation to peripheral nerve stimulation over the sensorimotor cortex during general anesthesia. The main objective of this study is to describe the changes in terms of event-related desynchronization and event-related synchronization modulations, in the EEG signal over the motor cortex during general anesthesia with propofol while a median nerve stimulation is performed. METHODS: STIM-MOTANA is an interventional and prospective study conducted with patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation at two different times: (1) when the patient is awake before surgery (2) and under general anesthesia. A total of 30 patients will receive surgery under complete intravenous anesthesia with a target-controlled infusion pump of propofol. RESULTS: The changes in event-related desynchronization and event-related synchronization during median nerve stimulation according to the various propofol concentrations for 30 patients will be analyzed. In addition, we will apply 4 different offline machine learning algorithms to detect the median nerve stimulation at the cerebral level. Recruitment began in December 2022. Data collection is expected to conclude in June 2024. CONCLUSIONS: STIM-MOTANA will be the first protocol to investigate median nerve stimulation cerebral motor effect during general anesthesia for the detection of intraoperative awareness. Based on strong practical and theoretical scientific reasoning from our previous studies, our innovative median nerve stimulation-based BCI would provide a way to detect intraoperative awareness during general anesthesia. TRIAL REGISTRATION: Clinicaltrials.gov NCT05272202; https://clinicaltrials.gov/ct2/show/NCT05272202. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/43870.

Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care.

Recent data indicated a high incidence of inappropriate management of neuromuscular block, with a high rate of residual paralysis and relaxant-associated postoperative complications. These data are alarming in that the available neuromuscular monitoring, as well as myorelaxants and their antagonists basically allow well tolerated management of neuromuscular blockade. In this first European Society of Anaesthesiology and Intensive Care (ESAIC) guideline on peri-operative management of neuromuscular block, we aim to present aggregated and evidence-based recommendations to assist clinicians provide best medical care and ensure patient safety. We identified three main clinical questions: Are myorelaxants necessary to facilitate tracheal intubation in adults? Does the intensity of neuromuscular blockade influence a patient's outcome in abdominal surgery? What are the strategies for the diagnosis and treatment of residual paralysis? On the basis of this, PICO (patient, intervention, comparator, outcome) questions were derived that guided a structured literature search. A stepwise approach was used to reduce the number of trials of the initial research ( n  = 24 000) to the finally relevant clinical studies ( n  = 88). GRADE methodology (Grading of Recommendations, Assessment, Development and Evaluation) was used for formulating the recommendations based on the findings of the included studies in conjunction with their methodological quality. A two-step Delphi process was used to determine the agreement of the panel members with the recommendations: R1 We recommend using a muscle relaxant to facilitate tracheal intubation (1A). R2 We recommend the use of muscle relaxants to reduce pharyngeal and/or laryngeal injury following endotracheal intubation (1C). R3 We recommend the use of a fast-acting muscle relaxant for rapid sequence induction intubation (RSII) such as succinylcholine 1 mg kg -1 or rocuronium 0.9 to 1.2 mg kg -1 (1B). R4 We recommend deepening neuromuscular blockade if surgical conditions need to be improved (1B). R5 There is insufficient evidence to recommend deep neuromuscular blockade in general to reduce postoperative pain or decrease the incidence of peri-operative complications. (2C). R6 We recommend the use of ulnar nerve stimulation and quantitative neuromuscular monitoring at the adductor pollicis muscle to exclude residual paralysis (1B). R7 We recommend using sugammadex to antagonise deep, moderate and shallow neuromuscular blockade induced by aminosteroidal agents (rocuronium, vecuronium) (1A). R8 We recommend advanced spontaneous recovery (i.e. TOF ratio >0.2) before starting neostigmine-based reversal and to continue quantitative monitoring of neuromuscular blockade until a TOF ratio of more than 0.9 has been attained. (1C).

Tranexamic Acid in Patients Undergoing Noncardiac Surgery.

BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).

A modified TOF-ratio to assess rocuronium-induced neuromuscular block: a comparison with the usual TOF-ratio.

BACKGROUND: The TOFscan is an acceleromyographic neuromuscular monitor that calculates and displays two measurements: first, a train-of-four (TOF) ratio, or ratio of the fourth twitch in the TOF-sequence, T4, and the first twitch, T1 (T4/T1). In addition, a second, modified ratio is displayed (T4/Tr), which refers to the ratio between T4 and a reference twitch (Tr), calculated as the mean value of the four twitches in a TOF-sequence [Tr = (T1 + T2 + T3 + T4)/4]. T4/Tr is calculated before establishment of neuromuscular block. METHODS: This prospective observational study included 35 adult patients. NMB induced by a rocuronium bolus of 0.6 mg/kg was continuously monitored at the adductor pollicis with the TOFscan and both TOF-ratios were simultaneously assessed. Primary outcome was the comparison of recovery to a TOF-ratio ≥ 0.9 calculated as T4/T1 and T4/Tr. RESULTS: The first value of the T4/T1 ≥ 90% was 90.9 (1.1) % and the simultaneously calculated T4/Tr was 69.6 (9.3) %, P < 0.001. The first value of the T4/Tr ≥ 90% was 90.5 (1.1) %, the simultaneously T4/T1 was 97.3 (2.5) %, P < 0.001. Time from injection of rocuronium to a TOF-ratio ≥ 90% was 56.2 ± 17.1 min for the T4/T1 and 65.3 ± 19.3 min for the T4/Tr, P < 0.001. During onset, a TOF ratio ≤ 20% was reached 145.5 (50.5) s after rocuronium when considering T4/T1, and 114.5 (45) s with the T4/Tr, P < 0.001. CONCLUSION: The present study shows the limitations of the usually determined acceleromyographic TOF ratio (T4/T1) in determining adequate neuromuscular recovery. The T4/T1 ratio significantly overestimates recovery compared with the T4/Tr ratio. Clinical decisions of adequate neuromuscular recovery based on the new T4/Tr ratio may reduce the incidence of residual paralysis and improve patient safety.

Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery.

BACKGROUND: For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. METHODS: The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. DISCUSSION: Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality. TRIAL REGISTRATION: ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.

Effect of a Perioperative Hypotension-Avoidance Strategy Versus a Hypertension-Avoidance Strategy on the Risk of Acute Kidney Injury: A Clinical Research Protocol for a Substudy of the POISE-3 Randomized Clinical Trial.

BACKGROUND: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes an acute kidney injury substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial, which is testing the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery. OBJECTIVE: To conduct a substudy of POISE-3 to determine whether a perioperative hypotension-avoidance strategy reduces the risk of acute kidney injury compared with a hypertension-avoidance strategy. DESIGN: Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy). INTERVENTION: If the presurgery systolic blood pressure (SBP) is <130 mmHg, all antihypertensive medications are withheld on the morning of surgery. If the SBP is ≥130 mmHg, some medications (but not angiotensin receptor blockers [ACEIs], angiotensin receptor blockers [ARBs], or renin inhibitors) may be continued in a stepwise manner. During surgery, the patients' mean arterial pressure (MAP) is maintained at ≥80 mmHg. During the first 48 hours after surgery, some antihypertensive medications (but not ACEIs, ARBs, or renin inhibitors) may be restarted in a stepwise manner if the SBP is ≥130 mmHg. CONTROL: Patients receive their usual antihypertensive medications before and after surgery. The patients' MAP is maintained at ≥60 mmHg from anesthetic induction until the end of surgery. SETTING: Recruitment from 108 centers in 22 countries from 2018 to 2021. PATIENTS: Patients (~6800) aged ≥45 years having noncardiac surgery who have or are at risk of atherosclerotic disease and who routinely take antihypertensive medications. MEASUREMENTS: The primary outcome of the substudy is postoperative acute kidney injury, defined as an increase in serum creatinine concentration of either ≥26.5 µmol/L (≥0.3 mg/dL) within 48 hours of randomization or ≥50% within 7 days of randomization. METHODS: The primary analysis (intention-to-treat) will examine the relative risk and 95% confidence interval of acute kidney injury in the intervention versus control group. We will repeat the primary analysis using alternative definitions of acute kidney injury and examine effect modification by preexisting chronic kidney disease, defined as a prerandomization estimated glomerular filtration rate <60 mL/min/1.73 m2. RESULTS: Substudy results will be analyzed in 2022. LIMITATIONS: It is not possible to mask patients or providers to the intervention; however, objective measures will be used to assess acute kidney injury. CONCLUSIONS: This substudy will provide generalizable estimates of the effect of a perioperative hypotension-avoidance strategy on the risk of acute kidney injury.

CONTEXTE: La plupart des patients qui prennent des médicaments antihypertenseurs continuent de les prendre le matin d'une intervention chirurgicale et pendant la période périopératoire. De plus en plus de preuves suggèrent que cette pratique pourrait entraîner l'hypotension périopératoire et augmenter le risque de complications. Ce protocole décrit une sous-étude sur l'insuffisance rénale aiguë (IRA) découlant de l'essai Perioperative Ischemic Evaluation-3 (POISE-3). Cet essai teste l'effet d'une stratégie d'évitement de l'hypotension périopératoire par rapport à une stratégie d'évitement de l'hypertension chez des patients qui subissent une chirurgie non cardiaque. OBJECTIFS: Cette sous-étude de l'essai POISE-3 vise à déterminer si une stratégie d'évitement de l'hypotension périopératoire réduit le risque d'IRA comparativement à la stratégie d'évitement de l'hypertension. TYPE D'ÉTUDE: Essai clinique randomisé à répartition 1:1 au groupe intervention (stratégie d'évitement de l'hypotension périopératoire) ou au groupe témoin (stratégie d'évitement de l'hypertension). GROUPE INTERVENTION: Si la pression artérielle systolique (PAS) avant l'opération est <130 mmHg, tous les médicaments antihypertenseurs sont suspendus le matin de la chirurgie. Si la PAS est ≥130 mmHg, certains médicaments (excluant les inhibiteurs de l'enzyme de conversion de l'angiotensine [IECA], les antagonistes du récepteur de l'angiotensine [ARA] ou les inhibiteurs de la rénine) peuvent être poursuivis de façon graduelle. Pendant la chirurgie, la pression artérielle moyenne (PAM) du patient est maintenue à ≥80 mmHg. Dans les 48 heures suivant l'intervention chirurgicale, certains médicaments antihypertenseurs (excluant les IECA, les ARA ou les inhibiteurs de la rénine) peuvent être réintroduits par étapes si la PAS est ≥130 mmHg. GROUPE TÉMOIN: Les patients reçoivent leurs médicaments antihypertenseurs habituels avant et après la chirurgie. La PAM du patient est maintenue à ≥60 mmHg de l'induction de l'anesthésie à la fin de l'intervention chirurgicale. CADRE: Recrutement à partir de 108 centres dans 22 pays entre 2018 à 2021. SUJETS: Des patients (~6 800) âgés de 45 ans et plus atteints d'athérosclérose, ou présentant un risque de l'être, devant subir une chirurgie non cardiaque et prenant des médicaments antihypertenseurs sur une base régulière. MESURES: Le principal critère d'évaluation de cette sous-étude est une IRA postopératoire définie par une hausse d'au moins 26,5 µmol/L (≥0,3 mg/dL) de la créatinine sérique dans les 48 heures suivant la randomisation ou d'au moins 50 % dans les 7 jours suivant la randomisation. MÉTHODOLOGIE: L'analyse primaire (par intention de traiter) examinera le risque relatif d'une IRA et l'intervalle de confiance à 95 % dans le groupe intervention par rapport au groupe témoin. Nous répéterons l'analyse primaire en utilisant d'autres définitions de l'IRA et nous examinerons la modification de l'effet en présence d'une insuffisance rénale préexistante (définie par un DFGe prérandomisation <60 ml/min/1,73 m2). RÉSULTATS: Les résultats de cette sous-étude seront analysés en 2022. LIMITES: Il n'est pas possible de procéder à l'insu des patients ou des prestataires de soins pour cette intervention; des mesures objectives seront toutefois utilisées pour évaluer l'IRA. CONCLUSION: Cette sous-étude fournira des estimations généralisables de l'effet d'une stratégie visant à éviter l'hypotension périopératoire sur le risque d'insuffisance rénale aiguë.

Does propofol mode of administration influence psychomotor recovery time after sedation for colonoscopy: A prospective randomized assessor-blinded trial.

BACKGROUND: Propofol sedation has become increasingly popular for colonoscopy. Different modes of propofol administration have been described, but their influence on psychomotor recovery time remains largely unknown. This prospective randomized assessor-blinded study tested the hypothesis that target-controlled infusion system (TCI) combined with sedation depth monitoring should be associated with a more stable sedation than intermittent bolus application with clinical monitoring of sedation depth, resulting in a faster psychomotor skills recovery. METHODS: One hundred sixty-four patients undergoing colonoscopy were randomized to receive propofol with the former (TCI group) or the latter (bolus group) mode of administration. Psychomotor skill recovery was assessed using the Choice Reaction Time (CRT) performed before and every ten minutes after waking up from propofol sedation. Clinical recovery was also assessed using the modified Post-anesthetic Discharge Scoring System (PADS). RESULTS: Induction and wake up times were longer in the TCI group, where patients received more propofol than those in the bolus group. Evolution of CRT was similar in both groups. Twenty minutes after arrival in the post-anesthesia care unit, 35 (49%) of patients in the TCI group and 43 (54%) in the bolus group achieved CRT values equal or shorter than their baseline values. Interestingly, according to the PADS score, most of the patients were considered fit for discharge at that moment. Incidence of adverse event was not different between groups. CONCLUSION: In the conditions of our study characterized by short procedure duration, target-controlled infusion of propofol does not offer any benefit in terms of psychomotor skills recovery over intermittent bolus application.

Neuromuscular block in patients 80 years and older: a prospective, controlled study.

BACKGROUND: An increasing number of patients older than 80 years are undergoing anesthesia, but little information is available regarding pharmacodynamic effects of myorelaxants in this population. This study aims to compare the time course of rocuronium neuromuscular block in patients ≥ 80 years with those of younger adults. METHODS: Under total intravenous anesthesia with propofol and sufentanil, time course of a bolus of rocuronium 0.6 mg/kg neuromuscular block was assessed with acceleromyography in patients ≥ 80 and in patients 20-50 years old. Onset time, clinical duration, duration until 90% and 100% recovery of baseline were determined. RESULTS: Data from 32 patients were analyzed, 16 were ≥ 80 years and 16 were 20-50 years old. Demographic data are shown in Table 1. In the group ≥ 80, onset time was 190 s ± 46 s compared to 123 s ± 40 s in the group 20-50, P < 0.001 and the clinical duration was 52 [48-69.5] min and 36 [34-41] min, respectively, P < 0.001. Duration to 90% recovery of baseline was 77.5 [71-88.5] min and duration to 100% recovery of baseline was 91.2 [82.2-98] min in patients ≥ 80 years and the corresponding values in the patients 20-50 years old were 53.5 [49-55.5] min and 59.5 [56.5-70.25] min, respectively, P < 0.001. CONCLUSION: Compared to younger adults rocuronium shifted in patients ≥ 80 years from a rapid onset, intermediate acting compound to a slower onset, long-acting compound. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03551652 (29/05/2018).

Impact of rocuronium on intraoperative neuromonitoring vagal amplitudes during thyroidectomy.

PURPOSE: Neuromuscular blocking agents (NMBA) facilitate endotracheal intubation and reduce related laryngeal morbidity. However, NMBA interfere with intraoperative neuromonitoring amplitudes during thyroidectomy. The goal of this study was to evaluate the impact of rocuronium used for tracheal intubation on early intraoperative neuromonitoring vagal amplitudes observed during first thyroid lobe dissection. METHODS: This is an observational pharmacoepidemiological study with prospective data collection and retrospective analysis. During the study period, all consecutive patients who underwent thyroid surgery with neuromonitoring were included. Patients underwent endotracheal intubation either using a single dose of rocuronium (NMBA group) or without NMBA (NMBA-free group) according to the anesthesiologist's preference. RESULTS: Six hundred six patients were included (213 NMBA and 393 NMBA-free group patients). At V1, 39 patients (18%) in the NMBA group had an amplitude < 100 µV (need for curarization reversal in 30 patients) and 13 patients (3.3%) in the NMBA-free group (p < 0.001). In the remaining 554 patients, the mean V1 amplitude was significantly decreased in the NMBA group (544 versus 685 µV; p < 0.001). After exclusion of 25 patients with loss of signal types 1 and 2 during dissection, the difference between mean V1 and mean V2 was significantly lower in NMBA group patients (- 22 versus - 86 µV; p = 0.016). CONCLUSION: This study provides new data showing how NMBA used for tracheal intubation significantly decrease V1 amplitude baseline and modify amplitude variations from V1 to V2 values during the first thyroid lobe dissection. LEVEL OF EVIDENCE: Pharmacoepidemiological study.

Does a balanced colloid decrease perioperative blood loss in paediatric cardiac surgery: A double-blinded randomized controlled trial?

BACKGROUND: Unbalanced fluid solutions cause metabolic acidosis and could be associated with impaired coagulation and increased blood loss. OBJECTIVE: To investigate whether the use of a balanced colloid compared with a saline colloid for peri-operative fluid therapy in children undergoing cardiac surgery is associated with decreased blood loss and exposure to blood products. DESIGN: Double-blinded randomised controlled trial. SETTING: Tertiary children's hospital from 2013 to 2016. PATIENTS: Children older than 29 days and younger than 3 years admitted for cardiac surgery with cardiopulmonary bypass (CPB). Exclusion criteria were emergency cardiac surgery, moribund (American Society of Anesthesiologists 5), Jehovah's witnesses, coagulopathy, renal failure, liver injury, intracranial haemorrhage and electrolyte disturbances. From the 128 patients eligible, 88 were included in the study. INTERVENTION: Random assignment of patients to either a saline colloid (6% hydroxyethyl starch 130/0.4 in 0.9% NaCl) or a balanced-electrolyte colloid (6% hydroxyethyl starch 130/0.4 in an isotonic solution) for CPB priming and intra- and postoperative fluid therapy during the first postoperative 48 h. MAIN OUTCOME MEASURE: The primary outcome measure was calculated blood loss until the third postoperative day (POD3). RESULTS: A total of 44 patients were included in each study arm. Calculated blood loss at POD3 was not significantly different between the groups (saline colloid 19.9 [IQR 13.8 to 26.1] ml kg-1 versus balanced colloid 15.9 [IQR 9.0 to 25.3 ml kg-1], P = 0.409). Secondary outcomes related to bleeding, exposure to blood products and coagulation were not different between groups. There was also no difference in length of mechanical ventilation, intensive care and hospital length of stay between groups. CONCLUSION: The use of a balanced colloid for peri-operative fluid therapy compared with a saline one is not associated with decreased blood loss or exposure to blood products. TRIAL REGISTRATION: EudraCT identifier: 2012-006034-17 and ClinicalTrial.gov identifier: NCT02584868.

A modified train-of-four ratio to assess recovery from depolarizing neuromuscular blockade after succinylcholine, a prospective observational study.

Succinylcholine is still used in clinical practice. Its duration is highly variable and neuromuscular monitoring is recommended to assess its recovery. Unfortunately, depolarizing neuromuscular block cannot be evaluated by train-of-four (TOF) as no fade occurs. Only single twitch (ST) allows to monitor depolarizing block. The TOFScan monitor proposes a modified TOF ratio (T4/Tref) not referring to fade within a TOF series. We hypothesized that the T4/Tref allows to assess recovery from succinylcholine. This observational study aims to compare recovery from depolarizing block simultaneously assessed with T4/Tref and ST. After Ethics Committee approval and written informed consent 45 patients receiving a single dose of succinylcholine were included. ST recovery, measured with TOF-Watch SX, and T4/Tref recovery, measured by TOFScan, were assessed simultaneously. Difference between measurements was compared using Mann-Whitney U test and overall concordance with the intraclass correlation coefficient (ICC). The ICC was 0.85 [95% CI 0.82-0.87]. The first T4/Tref ratio ≥ 90% was 97% [95% CI 93-101%] the corresponding ST value was 91% [95% CI 87-97%]. The first T4/Tref ratio ≥ 100% was 103% [95% CI 102-107%], the corresponding ST value was 104% [95% CI 100-106%]; median [95% confidence interval of the median]. Time to recovery to 90% and 100% of baseline did not differ between ST or T4/Tref. It was10.0 [8.0-13.0] min vs 10.0 [8.0-12.0] min, P = 0.307 and 10.0 [9.0-15.0] min vs 10.0 [8.0-15.0] min, P = 0.546; respectively; median [IQR]. Agreement between both parameters was excellent. The T4/Tref can be used accurately to measure recovery from depolarizing neuromuscular block.