INTRODUCTION:Optimal analgesia for thoracotomies remains unclear. Paravertebral blocks are more complex than local anesthetic infiltration but may be more effective. We therefore tested the hypothesis that paravertebral blocks provide better postoperative analgesia than local anesthetic infiltration in children recovering from cardiac surgery thoracotomies. METHODS:This was a single-center randomized double-blind trial. We recruited children aged 6-14 years with atrial or ventricular septal defects scheduled for cardiac surgery with cardiopulmonary bypass via thoracotomy were recruited. 100 patients were enrolled and randomized to either postoperative paravertebral blocks (n=50) or local anesthetic wound infiltration (n=50). We recorded opioid consumption during the initial 24 hours after surgery, along with pain scores at 6 hour intervals. Complications including postoperative nausea and vomiting and respiratory failure were also recorded. RESULTS:100 patients (mean 7 years, 43% male) were included in the analysis. The only postoperative opioid used was sufentanil. Total sufentanil consumption in the first 24 hours postsurgery was 0.3±0.4 µg/kg for those receiving paravertebral blocks, significantly lower than the 0.6±0.5 µg/kg for wound infiltration (p=0.002). Faces Pain Scale-Revised pain scores were consistently lower in the paravertebral block group across all measured time points (6, 12, 18, and 24 hours), with the most pronounced difference observed at 6 hours postoperatively (1.7±2.2 vs 3.3±2.2; p<0.001). Postoperative mechanical ventilation time, ICU stay, hospitalization, and incidence of postoperative nausea and vomiting were comparable. CONCLUSION:Paravertebral blocks reduced opioid consumption and pain during the first postoperative day in pediatric cardiac thoracotomies but did not accelerate recovery.
General anesthesia induces reversible changes in consciousness through cortical activity and connectivity alterations, yet the functional connectome dynamics underlying propofol-induced unconsciousness remains unclear. We analyze high-density 128-channel electroencephalogram (EEG) from 31 surgical patients using source localization to identify neurobiological connectome signatures of propofol anesthesia. Propofol anesthesia increases delta and theta functional connectivity and decreases alpha, beta, and gamma connectivity. A classification model and dynamic analysis of consciousness loss reveals that alpha-band connectivity between parietal, occipital, and subcortical regions is critical for sustaining consciousness, with its disruption marking a key transition to unconsciousness. EEG from 46 additional patients under mild sedation with low-dose propofol confirms that decreased parietal-related alpha connectivity serves as a stable marker of reduced consciousness, insensitive to subtle fluctuations but sensitive to the transition from consciousness to unconsciousness. These findings suggest that parietal, occipital, and subcortical alpha connectivity serves as a reliable neural correlate of propofol-induced unconsciousness.
BACKGROUND:The efficacy of superficial cervical plexus blocks for reducing persistent pain after craniotomies remains unclear. The authors tested the primary hypothesis that preoperative ultrasound-guided superficial cervical plexus blocks reduce persistent pain 3 months after suboccipital craniotomies. METHODS:A single-center randomized and blinded parallel-group trial was conducted. Eligible patients having suboccipital craniotomies were randomly allocated to superficial cervical plexus blocks with 10 ml 0.5% ropivacaine or a comparable amount of normal saline. Injections were into the superficial layer of prevertebral fascia. The primary outcome was the incidence of persistent pain three months after surgery. RESULTS:From November 2021 to August 2023, a total of 292 qualifying patients were randomly allocated to blocks with ropivacaine (n = 146) or saline (n = 146). The average ± SD age of participating patients was 45 ± 12 yr, and the duration of surgery was 4.2 ± 1.3 h. Persistent pain 3 months after surgery was reported by 48 (34%) of patients randomized to ropivacaine versus 73 (51%) in those assigned to saline (relative risk, 0.66; 95% CI, 0.50 to 0.88; P = 0.003) in the per-protocol population, and by 53 (36%) of patients randomized to ropivacaine versus 77 (53%) in those assigned to saline (relative risk, 0.69; 95% CI, 0.53 to 0.90; P = 0.005) in the intention-to-treat population. CONCLUSIONS:Superficial cervical plexus blocks reduce the incidence of persistent incisional pain by about a third in patients recovering from suboccipital craniotomies. EDITOR’S PERSPECTIVE:
BACKGROUND:Hydroxyethyl starch (HES) is often used for maintaining vascular volume during major surgery. Long-term high-dose HES in septic patients promotes renal injury, whereas meta-analyses of current HES products in surgical patients do not show such effects. OBJECTIVE:We studied if the peri-operative use of HES is noninferior to crystalloids in terms of acute kidney injury. Secondary outcome was the noninferiority of HES on worsening of renal injury and/or the incidence of a composite endpoint of major complications and mortality until postoperative day 90. DESIGN:Randomised double-blind trial in patients undergoing elective abdominal surgery with expected blood loss at least 500 ml. SETTING:Multicentre trial at 53 study sites in 10 European countries. PATIENTS:One thousand nine hundred and eighty-five (HES 977, crystalloid-only 981) patients aged 40 to 85 years with ASA status II-III. INTERVENTION:Either 6% HES 130/0.4 or a crystalloid solution. Dosing was guided by mean arterial pressure and/or routine haemodynamic variables. MAIN OUTCOME MEASURE:Change from pre-operative to lowest cystatin C-based eGFR during the first 3 postoperative days. Key secondary outcome was a composite endpoint of mortality and major postoperative complications after 90 days. RESULTS:Mean change in eGFR from baseline to minimum was -3.4 ± 17.7 ml min -1 1.73 m -2 in HES patients and -1.0 ± 17.1 ml min -1 1.73 m -2 in crystalloid-only patients ( P < 0.001 for noninferiority). The key secondary endpoint occurred in 35% of patients in each group. There were no clinically relevant differences in any safety endpoint including 90-day renal function. Any cause mortality-difference until the end of 1-year follow-up was not significantly different (8.6% in HES and 10.1% in crystalloid patients). CONCLUSION:Peri-operative use of HES was noninferior to crystalloids in short-term renal function or a composite of mortality and major complications at 90 days. PHOENICS provides robust evidence that peri-operative in-label use of HES is well tolerated. TRIAL REGISTRATION AND FUNDING:EudraCT no. 2016-002162-30, clinicaltrials.gov ID NCT03278548.
BACKGROUND:Vasoplegia during cardiac surgery is common and associated with perioperative mortality. Hydroxocobalamin is a catecholamine-sparing approach for treating vasoplegia. However, there is currently limited evidence to inform its use. METHODS:We conducted a single-centre retrospective propensity-matched cohort study of patients who developed vasoplegia after cardiopulmonary bypass. Our primary outcome was vasopressor requirement, expressed as norepinephrine equivalents (NEE), at 1, 4, 24, and 48 h after treatment. Our secondary outcome was a collapsed composite of in-hospital complications comprising stroke, sternal wound infection, mesenteric ischaemia, renal failure, and death. RESULTS:We identified 2727 (11%) patients with vasoplegia from 2018 to 2024. The final analysis cohort included 229 matched pairs. Hydroxocobalamin administration was associated with a significant reduction in median NEE infusion rates of -0.04 (95% confidence interval [CI]: -0.07 to -0.02; P=0.008) μg kg-1 min-1 at 1 h, -0.05 (95% CI: -0.07 to -0.02; P<0.001) μg kg-1 min-1 at 4 h, and -0.04 (95% CI: -0.06 to -0.02; P=0.004) μg kg-1 min-1 at 24 h, but not at 48 h, -0.02 (95% CI: -0.05 to 0.0; P=0.220) μg kg-1 min-1. Over the initial 24 h, hydroxocobalamin reduced NEE by 14% compared with the reference group. The risk of in-hospital complications was similar in each group (odds ratio: 1.06; 95% CI: 0.74-1.54; P=0.745). CONCLUSIONS:Hydroxocobalamin administration was associated with reduced vasopressor requirement over 24 h, but not thereafter. Robust trials are needed to determine whether this relationship is causal, and whether a reduction in vasopressor use improves substantive clinical outcomes.
BACKGROUND:Older surgical patients are at risk because of age-related physiologic decline and comorbidities. Some guidelines recommend Bispectral Index (BIS; Medtronic, USA) monitoring to optimize anesthetic depth, but robust evidence supporting improved outcomes is lacking. METHODS:A randomized, multicenter, double-blind trial was conducted across 21 tertiary-care hospitals in China (March 17, 2015, to February 5, 2022). Patients aged 65 yr or older scheduled for elective noncardiac surgery (American Society of Anesthesiologists [ASA] Physical Status I to IV) were randomized 1:1 to BIS-guided or routine anesthetic management. In patients assigned to BIS guidance, hypnotic depth was adjusted to maintain BIS between 40 and 60. Hypnotic depth in patients assigned to routine care per clinical judgment with masked BIS monitors. The primary outcome was 1-yr all-cause mortality. Secondary outcomes included moderate-to-severe complications within 30 days, functional independence, quality of life, the duration of postoperative critical care, the duration of postoperative hospitalization, unplanned intensive care unit admission, and hospital cost. RESULTS:Among 6,982 patients (mean ± SD age, 71 ± 5 yr), BIS values averaged 47 (BIS-guided) versus 46 (routine). One-year mortality was similar in BIS-guided patients (10.2% [356 of 3,485]) and routinely managed patients (10.0% [351 of 3,497]; hazard ratio, 1.02; 95% CI, 0.88 to 1.17; P = 0.812). The incidence of complications within 30 days after surgery were also comparable in each group: 10.4% versus 10.6% (relative risk, 0.99; 95% CI, 0.85 to 1.16; P = 0.938). No significant differences were observed in functional independence or quality of life. CONCLUSIONS:Hypnotic depth, as assessed by BIS, was similar in patients with or without BIS-guided anesthetic titration. Anesthesiologists thus apparently titrate hypnotic depth appropriately even without BIS guidance. Unsurprisingly, outcomes including postoperative 1-yr mortality and 30-day complications were similar in each group.
BACKGROUND:Improving comfort during and after surgery is a key concern for anaesthetists and other clinicians. With the inclusion of patient and public involvement, we undertook a Delphi consensus process to update previously recommended endpoints to be used in clinical trials evaluating treatments aiming to improve patient comfort after surgery. METHODS:We undertook a systematic review to identify domains and outcome measures of patient comfort used in perioperative studies. Focus groups, workshops, and a multi-round Delphi consensus process that included clinician-researchers and a patient experience and consumer group updated a recommended list of standardised endpoints focused on patient comfort. Consensus was defined as a median item score of 7 or greater and at least 70% of responses achieving a score of 7 or greater on a 9-point Likert scale. Additional ratings were done to determine validity, reliability, feasibility, and patient-centredness. Qualitative analyses were undertaken to identify themes. RESULTS:Response rates for each of the Delphi rounds were 100%. A final list of eight defined endpoints was identified: supplementary analgesic use, subjective analgesic effectiveness, pain intensity (at rest, during movement, and at 12, 24, and 72 h), postoperative nausea and vomiting (PONV, at 0-6 h, at 6-24 h, and overall), postdischarge nausea and vomiting (PDNV), severe PONV, quality of recovery (QoR-15), and time to mobilisation. All endpoints were assessed as valid, reliable, and feasible measures of patient comfort and were considered patient-centred. Patient and public involvement highlighted the importance of clear communication and shared decision-making to enhance comfort through the surgical journey. CONCLUSIONS:We recommend that at least some of these standardised endpoints be included as outcome measures in clinical trials assessing patient comfort and pain after surgery. SYSTEMATIC REVIEW PROTOCOL:Open Science Framework (10.17605/OSF.IO/DJQFE).
Sample size calculations for power analysis are critical for clinical research and trial design, yet their complexity and reliance on statistical expertise create barriers for many researchers. We introduce PowerGPT, an AI-powered system integrating large language models (LLMs) with statistical engines to automate test selection and sample size estimation in trial design. In a randomized trial to evaluate its effectiveness, PowerGPT significantly improved task completion rates (99.3
Background: Many diagnostic and interventional procedures are performed in bronchoscopy suites in high-risk patients. Minor impairment in respiratory muscle function caused by incomplete reversal of neuromuscular block can contribute to postoperative pulmonary complications (PPCs). We assessed whether there are fewer serious PPCs after diagnostic or therapeutic bronchoscopy when neuromuscular block is reversed with sugammadex rather than neostigmine. Methods: This is a retrospective cohort study for bronchoscopy under general anaesthesia with the use of neuromuscular blockers between July 2016 and June 2022. The primary outcome was a composite of PPCs. The secondary outcome was hypoxaemia. We used inverse probability of treatment weighting (IPTW) to adjust for confounding, fitting weighted outcome regression models to evaluate the association between the treatment and outcomes. Results: We analysed 8557 bronchoscopies across 6123 patients for the primary analysis. Adequate balance was achieved on all potential confounders after IPTW. The unweighted PPC incidence was 85/3830 (2.2%) for sugammadex and 93/4727 (2.0%) for neostigmine. The weighted PPC incidence was 2.7% for sugammadex and 1.9% for neostigmine. Sugammadex was associated with higher odds of experiencing the primary outcome of PPCs (odds ratio [OR]: 1.44; 95% confidence interval [CI]: 1.02-2.05; P=0.038), but not the secondary outcome of hypoxaemia (OR: 0.98; 95% CI: 0.81-1.20; P=0.878). Conclusions: Sugammadex was associated with a higher risk of PPCs than neostigmine. However, the absolute difference observed (0.8%) might not be clinically meaningful. Randomised trials are needed to more accurately determine the effect of neuromuscular block reversal agent selection on respiratory complications.
BACKGROUND:Perioperative hemodynamic abnormalities have been associated with neurocognitive outcomes after noncardiac surgery. OBJECTIVE:To compare the effects of perioperative hypotension-avoidance versus hypertension-avoidance strategies on delirium and 1-year cognitive decline after noncardiac surgery. DESIGN:Randomized controlled trial. (ClinicalTrials.gov: NCT03505723). SETTING:54 centers, 19 countries. PARTICIPANTS:2603 high-vascular-risk patients undergoing noncardiac surgery, receiving 1 or more chronic antihypertensive medications (mean age, 70 years). INTERVENTION:In the hypotension-avoidance strategy, the intraoperative mean arterial pressure (MAP) target was 80 mm Hg or greater; before and for 2 days after surgery, renin-angiotensin-aldosterone system inhibitors were withheld, and other chronic antihypertensive medications were administered for systolic blood pressures of 130 mm Hg or greater following an algorithm. In the hypertension-avoidance strategy, the intraoperative MAP target was 60 mm Hg or greater; all chronic antihypertensive medications were continued perioperatively. MEASUREMENTS:Delirium on postoperative day 1 to 3 (primary outcome); decline of 2 points or more at the Montreal Cognitive Assessment (MoCA) 1 year after surgery compared with baseline (secondary outcome). RESULTS:95 of 1310 patients (7.3%) in the hypotension-avoidance and 90 of 1293 patients (7.0%) in the hypertension-avoidance group had delirium (relative risk [RR], 1.04 [95% CI, 0.79 to 1.38]). Among 701 patients who completed 1-year MoCA (full or telephone version), 129 of 347 (37.2%) in the hypotension-avoidance and 117 of 354 (33.1%) in the hypertension-avoidance group had a decline of 2 or more points (RR, 1.13 [CI, 0.92 to 1.38]). Nineteen percent in the hypotension-avoidance and 27% in the hypertension-avoidance strategy had hypotension requiring an intervention (RR, 0.63 [CI, 0.52 to 0.76]), mostly intraoperatively; only 5%, in both groups, had hypotension postoperatively. LIMITATION:The COVID-19 pandemic challenged site participation in the substudy; although large, the sample size was lower than expected. CONCLUSION:There was no evidence of a difference in neurocognitive outcomes between the hypotension-avoidance and hypertension-avoidance strategies. PRIMARY FUNDING SOURCE:Canadian Institutes of Health Research, Canada; National Health and Medical Research Council, Australia; Research Grant Council, Hong Kong SAR, China.
Tranexamic acid (TXA) is a synthetic antifibrinolytic agent widely used in a diverse range of hemorrhagic scenarios. Despite documented superior safety profile, increasing reports have emerged describing anaphylactic reactions to TXA. We reviewed reported cases of anaphylactic reactions to TXA and summarize their clinical characteristics, diagnosis and treatment protocols. PubMed, Embase, Web of Science were searched with the terms “tranexamic acid”, “antifibrinoly*”, “anaphylaxis”, “anaphylactic”, “anaphylactoid”, “allergy” and “hypersensitivity” to identify relevant case reports. Data were extracted and analyzed. Our review identified 15 cases of TXA-induced anaphylaxis. Patients were 2 to 80 years old, with 60.0
BACKGROUND:Hypotension after induction of general anaesthesia is common in high-risk patients having noncardiac surgery. Anaesthesiologists often give manual boluses of vasopressors repeatedly to maintain blood pressure during induction of general anaesthesia, including the fast-acting vasopressor norepinephrine which has a short half-life. We tested the hypothesis that giving norepinephrine continuously during induction of general anaesthesia, compared with giving it as repeated manual boluses, improves blood pressure stability in high-risk noncardiac surgery patients. METHODS:In this single-centre trial, 72 participants undergoing noncardiac surgery were randomised to continuous norepinephrine infusion or manual bolus norepinephrine administration during induction of general anaesthesia. Blood pressure was monitored continuously with an arterial catheter. The primary endpoint was blood pressure stability, quantified as the generalised average real variability of mean arterial pressure within 15 min after starting induction of general anaesthesia. RESULTS:A total of 71 participants completed the study (mean [range] age: 66 [47-86] y; 48% female). The mean (standard deviation) generalised average real variability of mean arterial pressure was 19 (6) mm Hg min-1 in 36 participants assigned to continuous norepinephrine infusion, compared with 25 (7) mm Hg min-1 in 35 participants assigned to manual bolus norepinephrine administration (P<0.001). CONCLUSIONS:Giving norepinephrine continuously during induction of general anaesthesia, compared with giving it as repeated manual boluses, improved blood pressure stability in higher-risk individuals undergoing noncardiac surgery. CLINICAL TRIAL REGISTRATION:NCT05997303.
Background Intraoperative hypotension is associated with cardiovascular complications after major noncardiac surgery, but randomized trials assessing whether intensive blood pressure management during surgery can reduce these complications have shown inconsistent results. Objectives The purpose of this study was to determine whether intensive intraoperative blood pressure management reduces the incidence of a composite of cardiovascular complications within 30 days after major abdominal surgery. Methods In this investigator-initiated parallel-group trial, patients at 3 Chinese sites were randomly assigned (1:1) to intensive blood pressure management targeting intraoperative MAP ≥80 mm Hg (intensive strategy group) or conventional management targeting intraoperative MAP ≥ the higher of 65 mm Hg or 60% of preoperative baseline pressure (conventional strategy group). We included patients aged ≥45 years who had known cardiovascular disease or cardiovascular risk factors and were scheduled for inpatient abdominal surgery expected to last at least 2 hours. The primary outcome was a composite of myocardial injury or infarction, new-onset clinically important arrhythmias, acute heart failure, stroke, cardiac arrest, and all-cause death within 30 days of surgery. Results Between June 30, 2020, and September 23, 2022, 1,500 patients were enrolled, of whom 1,477 were included in the modified intention-to-treat population (739 in the intensive strategy group and 738 in the conventional strategy group). Patients assigned to intensive intraoperative blood pressure management experienced a lower burden of hypotension exposure, as assessed by several measures. For example, the median cumulative duration of MAP <65 mm Hg was 1 minute (Q1-Q3: 0-7 minutes) in the intensive strategy group, compared with 8 minutes (Q1-Q3: 0-20 minutes) in the conventional strategy group. The primary composite outcome occurred in 107 of 739 patients (14.5%) in the intensive strategy group and 100 of 738 patients (13.6%) in the conventional strategy group (relative risk: 1.07; 95% CI: 0.83-1.38; P = 0.61). Conclusions In high-risk patients having major abdominal inpatient surgery, intensive intraoperative blood pressure management targeting a mean arterial pressure ≥80 mm Hg did not reduce the incidence of cardiovascular events compared with the conventional target of ≥65 mm Hg and 60% of the preoperative baseline.
BACKGROUND:Oliceridine is a G protein-selective μ-opioid receptor agonist with reduced β-arrestin activation that may produce fewer opioid-related adverse effects (ORAEs) than traditional opioids. The VOLITION prospective cohort study evaluated oliceridine for management of postoperative pain and evaluated ORAEs. METHODS:We enrolled 204 patients scheduled for major noncardiac surgery. Our primary aim was to quantify the proportion of patients having respiratory compromise over the initial two postoperative days. Cardiorespiratory function was continuously monitored with pulse oximetry, capnography, and plethysmography. Our composite of clinically meaningful respiratory events was defined by an end-tidal (Et) CO2 ≤ 15 mmHg for ≥3 min, respiratory rate ≤ 5 breaths/min for ≥3 min, oxygen saturation ≤ 85 % for ≥3 min, apnea lasting >30 s, or any life-threatening respiratory events. All potential respiratory events were adjudicated by two independent expert reviewers. On an exploratory basis we evaluated the proportion of patients achieving a complete gastrointestinal response (no vomiting and no rescue antiemetic use). Central nervous system compromise was evaluated with the Richmond Agitation-Sedation Scale, the Pasero Opioid-Induced Sedation Scale, and the 3-min Diagnostic Confusion Assessment Method. RESULTS:Among 203 patients in the safety population (mean age 57 years, 52 % women; mean duration of surgery: 5 h), 197 patients had cardiorespiratory data available for analysis. The median cumulative oliceridine dose was 33 mg (range 1.5-75 mg). There were 174 adjudicated episodes of respiratory compromise in 45 patients (23 %) but no deaths or oliceridine-related serious adverse events. Naloxone opioid reversal was never required. There were 107 (53 %) patients who had a complete gastrointestinal response, and eight met screening criteria for delirium. CONCLUSION:Nearly one quarter of patients experienced a respiratory compromise with oliceridine analgesia, none of which was life-threatening. A randomized trial needs to determine whether oliceridine produces fewer overall ORAEs than conventional opioids. The study was registered at ClinicalTrials.gov (NCT04979247).
Background:Postinduction hypotension is common and associated with organ injury but might be largely preventable by careful anaesthetic management. We thus aimed to quantify the severity and duration of postinduction hypotension in high-risk noncardiac surgery patients treated with a hypotension prevention bundle. Methods:In this prospective single-arm interventional proof-of-concept study, 107 high-risk noncardiac surgery patients were treated with a hypotension prevention bundle. The bundle included continuous intra-arterial blood pressure monitoring, a hypotension alarm set at a mean arterial pressure (MAP) of 75 mm Hg, careful administration of anaesthetic drugs, and continuous administration of norepinephrine when MAP decreased below 75 mm Hg. The primary endpoint, AUC65, was derived from a plot of MAP over time for the first 15 min after induction of general anaesthesia as the area of the plot under a MAP of 65 mm Hg . Results:Of 107 patients, 55 (51%) had at least one MAP reading <65 mm Hg, but only 16/107 patients (15%) had a MAP <65 mm Hg for at least one continuous minute. Patients had a MAP <65 mm Hg for a median (25% percentile, 75% percentile; minimum-maximum) of 0.2 min (0.0, 0.8; 0.0-5.2 min). The median AUC65 was 0.1 mm Hg . min (0.0, 4.1; 0.0-40.6 mm Hg min). Conclusions:We observed minimal postinduction hypotension in high-risk noncardiac surgery patients treated with a hypotension prevention bundle. However, randomised trials are needed to confirm that using the hypotension prevention bundle helps reduce postinduction hypotension.
STUDY OBJECTIVE:To determine whether intraoperative low-dose esketamine ameliorates depression in women having breast cancer surgery. DESIGN:A prospective single-center double blind randomized placebo-controlled trial. SETTING:Perioperative period, operating room, post anesthesia care unit and hospital ward. PATIENTS:108 women 18-65 years old who were scheduled for elective breast cancer surgery. All had preoperative depressive symptoms as defined by Montgomery-Åsberg depression scores ≥12 (range, 0-60; higher scores indicate more severe depression). INTERVENTIONS:Eligible participants were randomized to esketamine 0.25 mg/kg or saline placebo. Blinded trial drugs were given intravenously over the initial 40 min of anesthesia. MEASUREMENTS:Our primary outcome was the fraction of patients who had at least a 50 % reduction in the Montgomery-Åsberg depression score within 3 postoperative days. Secondary outcomes included the fraction of patients with depression remission defined as Montgomery-Åsberg scores ≤10, the numeric value of the Montgomery-Åsberg depression scores, postoperative severe pain, and anxiety as determined by the Generalized Anxiety Disorder 7-item score. Adverse events were monitored for 72 postoperative hours. MAIN RESULTS:54 women each were randomized to esketamine and saline, and 104 were available for our intent-to-treat analysis. The mean age was 50 years. Esketamine non-significantly doubled the fraction of patients who had a 50 % reduction in their depressions scores: 27 % vs 13 %, odds ratio 2.4, [95 % CI 0.9 to 6.6], P = 0.087. Montgomery-Åsberg depression scores were nearly a factor-of-two and significantly lower (better) on postoperative days 1 to 5 in patients given esketamine. Montgomery-Åsberg scores decreased significantly more from baseline in patients randomized to esketamine: mean difference - 2.5 [95 % CI -4.5 to -0.6], P = 0.010. Esketamine treatment had no significant effect on other secondary outcomes or on adverse events. CONCLUSIONS:Intraoperative administration of 0.25 mg/kg esketamine did not significantly improve the fraction of depressed women having breast cancer patients who had a 50 % reduction in their depression scores at 3 days postoperatively. However, the observed factor-of-two treatment effect was clinically meaningful and esketamine significantly reduced short-term postoperative depression scores without provoking complications. Robust trials are warranted. Registration Trial registry:http://www.chictr.org.cn/; Identifier: ChiCTR2300071062.
Introduction: Patients with high-grade gliomas often have severe brain edema. Goal-directed fluid management protects neurological function, but whether reduces postoperative brain edema remains unknown. Methods: Patients having elective resection of supratentorial malignant gliomas were randomly assigned to goal-directed versus routine fluid management. Patients assigned to goal-directed management group were given 3 ml kg-1 hydroxyethyl starch solution when stroke volume variation exceeded 15% for 5 min. Fluid was managed per routine by attending anesthesiologists in reference patients. The primary outcome was cerebral edema volume after surgery as assessed by computerized tomography. Results: A total of 480 eligible patients were randomly assigned to the goal-directed (n = 240) or the routine fluid management group (n = 240). The amounts of crystalloid (5.4 vs. 7.0 ml kg(-1) hour(-1), P < 0.001), colloid (1.1 vs. 1.7 ml kg(-1) hour(-1), P < 0.001), and overall fluid balance (0.3 vs. 1.9 ml kg(-1) hour(-1), P < 0.001) were significantly lower in goal-directed fluid management group. There was no significant difference in postoperative brain edema volume between groups (36.0 vs. 38.9 cm3, mean difference: 0.18 cm3, 95% CI: -5.7 to 5.9). Goal-directed patients had lower intraoperative dural tension (risk ratio: 0.63, 95% CI: 0.50-0.80, P < 0.001). There was no significant difference in Karnofsky Performance Status between the two groups at 30 days after surgery. Conclusions: Goal-directed fluid therapy substantially reduced intravenous fluid volumes, but did not reduce postoperative brain edema in patients having brain tumor resections.
BACKGROUND:Perioperative hypothermia remains a common and preventable complication. Forced-air warming systems are widely used, but comparative data on their effectiveness are limited. This study aimed to evaluate heat flux, mean skin temperature, and thermal comfort across five full-body forced-air warming blower and cover combinations. METHODS:In a randomized crossover trial conducted in a controlled clinical setting, 20 healthy volunteers were each warmed for 30 min using five different forced-air warming systems in randomized order. A 45-min washout period separated each warming session. Cutaneous heat flux and area-weighted mean skin temperature were recorded every 5 min, and thermal comfort was assessed every 10 min. Data were analyzed using repeated-measures ANOVA and linear mixed-effects modeling, with significance defined as P < 0.05. RESULTS:All 20 volunteers completed the trial. Mean age was 29 yr, 40% were women, and mean body mass index was 24 kg/m 2 . Ambient temperature averaged 20.3° ± 2.4°C. Across all warming systems, average heat flux improved from a loss of 101 ± 53 W to a gain of 20 ± 48 W after just 5 min of heating. Skin temperature increased to 35.5° ± 0.8°C within 15 min of warming, remaining stable thereafter. CONCLUSIONS:All five forced-air warming systems transferred substantial amounts of heat. There were no statistically significant or clinically meaningful differences in cutaneous heat transfer, mean skin temperature, or thermal comfort across the systems. Any of the tested systems will therefore prevent hypothermia in most surgical patients.