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.

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.

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.).

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.

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.

Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial.

BACKGROUND: There is a controversy in the literature whether deep compared with moderate neuromuscular block (NMB) improves surgical conditions for laparoscopic surgery. OBJECTIVES: The primary outcome measure was to examine whether switching from moderate to deep NMB improves surgical conditions for laparoscopic surgery in the obese; secondary outcome measures were changes in intra-abdominal pressure, time required to perform the gastrojejunal anastomosis and peri-operative surgical complications. DESIGN: A single-centre, randomised controlled study. Each patient was taken as their own control and examined twice: at the first evaluation (E1), all patients had a moderate NMB, thereafter patients were randomised to deep or moderate block and a second evaluation (E2) was performed within 10 min. Patients with excellent rating at E1 were excluded from E2, as their surgical condition could not be further improved. SETTING: University Hospital France. PATIENTS: Patients undergoing laparoscopic gastric bypass surgery under general anaesthesia were included. Main exclusion criteria were hypersensitivity to the drugs used and absence of written informed consent. INTERVENTIONS: According to the group assignment, patients received bolus doses of rocuronium or 0.9% saline. MAIN OUTCOME MEASURES: Surgical conditions were assessed with a 4-point rating scale. Intra-operative adverse events were assessed with the Kaafarani-classification and postoperative complications with the Clavien-Dindo classification. RESULTS: Eighty-nine patients were initially included and data from 85 could be assessed at E1; surgical rating was excellent in 20, good in 35, acceptable in 18, poor in 12. After excluding those with an excellent rating, the remaining 65 patients were randomly assigned to deep or moderate block. At E2, an improvement of surgical conditions was observed in 29 out of 34 patients with deep block and in four out of 31 with moderate block; P < 0.0001. Poor surgical conditions were more frequently associated with surgical complications (61.5 versus 15.3%; P < 0.001). CONCLUSION: Switching from moderate to deep block improves surgical conditions. Poor surgical conditions were associated with a higher incidence of surgical complications. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02118844.

Pleth variability index versus pulse pressure variation for intraoperative goal-directed fluid therapy in patients undergoing low-to-moderate risk abdominal surgery: a randomized controlled trial.

BACKGROUND: Goal-directed fluid therapy (GDFT) based on dynamic indicators of fluid responsiveness has been shown to decrease postoperative complications and hospital length of stay (LOS) in patients undergoing major abdominal surgery. The usefulness of this approach still needs to be clarified in low-to-moderate risk abdominal surgery. Both pulse-pressure variation (PPV) and pleth variability index (PVI) can be used to guide GDFT strategies. The objective of this prospective randomized controlled trial was to determine if the use of PVI guided GDFT, when compared to PPV guided GDFT, would lead to similar hospital LOS in patients undergoing low-to-moderate risk surgery. Secondary outcomes included amount of fluid administered and incidence of postoperative complications. METHODS: Patients were randomized into either PVI or PPV guided GDFT groups. Both received a baseline 2 ml kg- 1 h- 1 Lactated Ringer infusion. Additional fluid boluses consisted of 250 mL of colloid that was infused over a 10 min period if PVI was > 15% or PPV was > 13% for at least five minutes. The primary outcome was to determine if hospital LOS, which was defined as the number of days from surgery up to the day the surgeon authorized hospital discharge, was equivalent between the two groups. RESULTS: A total of 76 patients were included and they were randomized into two groups of 38 patients. Baseline characteristics were similar in both groups. Both PVI and PPV guided GDFT strategies were equivalent for the primary outcome of LOS (median [interquartile range]) (days) 2.5 [2.0-3.3] vs. 3.0 [2.0-5.0], p = 0.230, respectively. Fluids infused, postoperative complications, and all other outcomes were not different between groups. CONCLUSION: In patients undergoing low-to-moderate risk abdominal surgery, PVI seems to guide GDFT similarly to PPV in regards to hospital LOS, amount of fluid, and incidence of postoperative complications. However, in low-risk patients undergoing these surgical procedures optimizing stroke volume may have limited impact on outcome. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02908256 , September 2016, retrospectively registered.

Recurrent Laryngeal Nerve Monitoring and Rocuronium: A Selective Sugammadex Reversal Protocol.

BACKGROUND: The use of neuromuscular blocking agents may affect intraoperative neuromonitoring during thyroid surgery. A selective neuromuscular recovery protocol was evaluated in a retrospective cohort study during human thyroid neural monitoring surgery. METHODS: One hundred and twenty-five consecutive patients undergoing thyroidectomy with intraoperative neuromonitoring followed a selective neuromuscular block recovery protocol-single intubating dose of rocuronium followed by sugammadex if needed at the first vagal stimulation (V1). RESULTS: Data from 120 of 125 patients could be analysed. Fifteen (12.5%) patients needed sugammadex reversal to obtain an EMG response at the first vagal stimulation (V1). In the remaining 105 patients, spontaneous recovery of rocuronium-induced neuromuscular block was sufficient for a successful first vagal stimulation (V1). CONCLUSIONS: In patients undergoing thyroid surgery, routine reversal of rocuronium block with sugammadex is not mandatory for reliable intraoperative neuromonitoring. A selective neuromuscular block recovery approach may be a valuable and more cost-efficient alternative to routine reversal.

Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia.

BACKGROUND: Heterogeneity in microvascular perfusion is associated with impaired tissue oxygenation. We hypothesized that cardiac surgery with or without cardiopulmonary bypass (CPB) could induce microvascular alterations. METHODS: We used an orthogonal polarization spectral imaging technique to evaluate the sublingual microcirculation in patients undergoing cardiac surgery with (n = 9) or without (n = 6) CPB. We also included, as a control group, 7 patients undergoing thyroidectomy with the same anesthetic procedure. Hemodynamic and microcirculatory variables were obtained the day before surgery, after induction of anesthesia, during CPB, on admission to the intensive care unit or the recovery room, and 6 and 24 hours after the end of the surgical procedure. Data are presented as median (25th to 75th percentile). RESULTS: No differences in hemodynamic variables were observed between the two cardiac surgery groups. The proportion of perfused vessels was similar in all three groups at baseline (89% [87% to 90%]), and decreased similarly after induction of anesthesia to 71% (69% to 74%). It decreased further during CPB to 53% (50% to 56%). On admission to the intensive care unit or recovery room, alterations were more severe in CPB than in off-pump patients (60% [59% to 62%] versus 64% [61% to 65%]; p = 0.03), whereas they had already normalized in thyroidectomy patients (89% [86% to 90%]; p = 0.0005 versus cardiac surgery). In both cardiac surgery groups these microcirculatory alterations decreased with time, but persisted at 24 hours. The severity of microvascular alterations correlated with peak lactate levels after cardiac surgery (y = 11.5 - 0.15x; r(2) = 0.65; p < 0.05). CONCLUSIONS: Microcirculatory alterations are observed in cardiac surgery patients whether or not CPB is used. Anesthesia contributes to these alterations, but its effects are transient.

No evidence of memory processing during propofol-remifentanil target-controlled infusion anesthesia with bispectral index monitoring in cardiac surgery.

OBJECTIVE: Auditory information presented during anesthesia can activate memory. Surgical stimulation may enhance memory formation. The authors' hypothesis is that implicit memory processing is not preserved during unconsciousness, even in the presence of a surgical stimulus. DESIGN: A double-blind randomized controlled trial. SETTING: A single-institution, university hospital. PARTICIPANTS: Thirty-eight adults undergoing cardiac surgery. INTERVENTIONS: Patients were randomized to continuously hear either disc A or B during surgery. On each disc, 20 different words were recorded. MEASUREMENTS AND MAIN RESULTS: Implicit and explicit memory were tested. The study design was that each group served as a control for the other. The responses from both groups on both lists allowed the authors to compare the likeliness of correctly identifying the words from a list whether it was heard while under anesthesia or not. During the interview, no patient had explicit recall as investigated by the free recall test, and no one reported dreaming. As for implicit memory processing, the difference between the mean rate of correct answers on the word-stem completion test for the disc the patients heard (3.42% for disc A and 13.15% for disc B) or did not hear (3.15% for disc A and 14.73% for disc B) was not statistically significant (p = 0.95 for A and p = 0.42 for B). CONCLUSIONS: Explicit and implicit memory were not detectable in patients anesthetized with an effect-site target-controlled infusion of propofol and remifentanil with bispectral index monitoring. These results suggest that there is no memory processing under anesthesia in the surgical setting.

Assessment of thoracic epidural analgesia during general anesthesia using pupillary reflex dilation: a preliminary study.

OBJECTIVE: Pupillary reflex dilation (PRD) secondary to noxious stimulation accurately predicts sensory block during combined lumbar epidural/general anesthesia. Therefore, the adequacy of PRD-guided thoracic epidural infusion during general anesthesia for thoracotomy was studied. DESIGN: Prospective study. SETTING: University hospital. PARTICIPANTS: Thirteen patients undergoing thoracotomy. INTERVENTIONS: An epidural catheter was placed at the T3-T4 level with initial infusion rate of 5 mL/h of ropivacaine 0.5%. Propofol/remifentanil target-controlled infusion was used for induction and maintenance of general anesthesia. Remifentanil effect site concentration was maintained constant at 0.5 ng/mL during surgery. By using a portable pupillometer, PRD secondary to tetanic stimulation of the C8, T2, and T4 segments were evaluated. Ropivacaine flow rate was adapted half hourly, according to PRD testing and a predefined algorithm. At the end of surgery, PRD was tested in the 3 investigated segments, and general anesthesia was stopped. After emergence, these zones were tested for their sensitivity to cold. Pain was evaluated by using the visual analog scale. RESULTS: Pain scores were <3 of 10 in 84.6% of the patients. Mean PRD was 0.9 +/- 0.6 mm in unblocked levels versus 0.2 +/- 0.5 mm in blocked segments (p = 0.02). PRD >or= 0.5 mm was predictive of incomplete block (sensitivity 76%, specificity 79%, and positive predictive value 86%). PRD >or= 1 mm was highly predictive of inadequate block (sensitivity 73%, specificity 91%, and positive predictive value 94%). CONCLUSION: PRD-guided continuous thoracic epidural analgesia under low-dose remifentanil/propofol anesthesia is feasible and ensures good postoperative analgesia.

3.5% urea-linked gelatin is as effective as 6% HES 200/0.5 for volume management in cardiac surgery patients.

PURPOSE: To compare the efficacy of volume expansion with 3.5% gelatin and 6% hydroxyethyl starch 200/0.5 in patients undergoing cardiac surgery. The second objective was to compare the two colloids in terms of blood losses and allogeneic blood transfusion exposure rate. METHODS: In this open-label controlled study, patients were randomly allocated to receive either 3.5% urea-linked gelatin (GEL group: n = 55) or 6% hydroxyethyl starch 200/0.5/5.1 (HES group: n = 55) for per- (including priming of the bypass machine) and postoperative volume management with a maximum dosage of 30 +/- 3 mL.kg(-1).day(-1). Volume replacement was guided according to routine per- and postoperative care based on cardiac index, mixed venous oxygen saturation, and diuresis. If additional colloid was required, 4.5% albumin had to be given. The study period comprised per- and postoperative investigations up to 18 hr after surgery. RESULTS: All hemodynamic variables were comparable in both groups. Total study drug was 25.8 +/- 4.8 mL.kg(-1) in the GEL group and 24.5 +/- 6.0 mL.kg(-1) in the HES group. There was no difference in the number of patients receiving albumin solution or in the amount of albumin administered. Total blood loss was higher in the HES than in the GEL group (11.0 +/- 7.8 mL.kg(-1) vs 8.7 +/- 4.0 mL.kg(-1); P < 0.05) resulting in a higher need for allogeneic blood transfusion (HES: nine patients received 12 units, GEL two patients received 3 units; P = 0.026). CONCLUSION: In the conditions of the present study, HES was not associated with a better plasma expansion effect than GEL. HES could result in a higher need for allogeneic blood transfusion.