Background Inhalation anaesthesia or propofol-based TIVA are the two primary options for administering general anaesthesia. Shared decision-making between clinicians and patients is critical. This study explores the perspectives of both anesthesia clinicians and patients on general anaesthesia techniques, aiming to identify gaps in communication and decision-making. Methods Two surveys were conducted in December 2020: an 18-item clinician survey disseminated through the Multicenter Perioperative Outcomes Group to clinicians who administer general anesthesia and a 33-item patient survey distributed via Amazon Mechanical Turk to individuals who had undergone surgery using general anaesthesia. The clinician survey focused on preferences regarding use of general anaesthesia techniques, discussion practices, and perceived barriers to TIVA use. The patient survey assessed preoperative discussions and preferences for anaesthetic techniques. Data were analysed using descriptive statistics. Results Of the 1123 anesthesia clinician respondents [comprised mostly of anaesthesiology attendings (47.8%) or Certified Registered Nurse Anesthetists (CRNAs, 34.6%)], when asked if they or a family member required general anaesthesia; 40% preferred TIVA, 13% preferred inhalation anesthesia and 33% indicated no preference. Nearly 80% of clinicians did not routinely discuss general anaesthetic technique options with patients. Among the 509 eligible patients (mean age: 38.1 yr), 65% reported that their anaesthesia team discussed general anaesthesia options, and 63% were offered a choice. Both anesthesia clinicians and patients identified intraoperative awareness risk and recovery quality as important factors influencing preferences. Conclusions This study highlights discrepancies between patient perceptions of shared decision-making and anesthesia clinicians’ reported practices for general anesthesia techniques in US hospitals. Further comparative studies are needed to address these communication gaps and support evidence-based shared decision-making in anaesthetic care.
Objectives:. To explore patient experiences with a perioperative mental health intervention (PMHI), understand its perceived impact on emotional health, and identify factors affecting engagement and feasibility. Background:. Depression and anxiety can worsen surgical outcomes in older adults, highlighting the need for perioperative emotional health support. We evaluated a PMHI across 3 linked randomized controlled trials in cardiac, oncologic, and orthopedic surgery. Here, we report qualitative findings highlighting patients’ experiences with the PMHI across trials. Methods:. The study was conducted across 3 hospitals in a Midwestern healthcare network. 112 semi-structured interviews were conducted with older patients undergoing surgeries (31 cardiac, 39 oncologic, and 42 orthopedic), complemented by 5 periodic reflection focus groups with 9 interventionists (4 social workers/counselors and 5 pharmacist team members). An inductive thematic approach was used for analysis. Results:. Patients and interventionists perceived the PMHI positively, identifying numerous beneficial factors such as compassionate care, strong rapport, and thorough medication education. However, patients noted nonbeneficial factors limiting engagement with the PMHI, including fatigue and competing personal priorities. Patients with oncologic or complex cardiac procedures reported the greatest benefit from the PMHI, compared with slightly lower perceived usefulness among orthopedic and simpler cardiac patients. Informed by these findings, we present a conceptual model illustrating beneficial and nonbeneficial factors influencing patient perceptions of the PMHI. Conclusions:. Patients’ positive perceptions of the PMHI and its impact on alleviating depression and anxiety symptoms underscore the value of integrating psychological and pharmacological support into perioperative care for older adults.
Importance Depression and anxiety are common among older adults undergoing surgery and are associated with adverse postoperative outcomes. However, effective tailored perioperative mental health interventions are lacking. Objective To evaluate a perioperative intervention to optimize mental health. Design, Setting, and Participants A single-blind, hybrid, type 1, effectiveness-implementation randomized clinical trial was conducted (November 1, 2022, to March 31, 2025), with 3-month postoperative follow-up, at a US academic and community practice hospital network. Participants were 60 years or older; scheduled for cardiac, oncologic, or orthopedic surgery; and had clinically meaningful symptoms of depression and/or anxiety based on the Patient Health Questionnaire–Anxiety and Depressive Symptom (PHQ-ADS) scale. A total of 3159 patients were screened for eligibility, with 1518 ineligible, 1079 declining participation, and 236 excluded for other reasons. A total of 326 patients were enrolled and randomized (1:1), with 20 excluded after surgery cancelation. Intervention Participants were assigned to receive a perioperative intervention combining psychological management and pharmacologic optimization or enhanced usual care (materials for self-managing symptoms). Main Outcomes and Measures The primary outcome was change in PHQ-ADS score from baseline to 3 months after surgery. Other outcomes included persistent postsurgical pain, delirium, falls, quality of life, patient satisfaction, length of stay, and rehospitalizations. Implementability was evaluated through semistructured interviews and reach, acceptability, feasibility, appropriateness, and fidelity measures. Results A total of 306 older adults were included in analysis (mean [SD] age, 68.5 [6.1] years; 209 [68.3%] female; 153 randomized to intervention and 153 randomized to enhanced usual care): 102 cardiac, 100 oncologic, and 104 orthopedic patients. Participants’ mean (SD) baseline PHQ-ADS score was 18.5 (7.4). At 3 months, there was a significant decrease in PHQ-ADS scores in the intervention group compared with the enhanced usual care group (mean difference, 2.20; 95% CI, 0.16-4.24; P = .03). Effects varied by surgical subgroups (oncologic patients: mean difference, 4.93; 95% CI, 1.51-8.36; P = .005; cardiac patients: mean difference, 2.68; 95% CI, −0.98 to 6.35; P = .15; and orthopedic patients: mean difference, −1.11; 95% CI, −4.62 to 2.40; P = .54). Patients and interventionists perceived the intervention as appropriate, with high-fidelity delivery and broad reach across the target population. Conclusions and Relevance In this randomized clinical trial, psychological management and pharmacologic optimization reduced anxiety and depression in older adults undergoing surgery. Future studies should assess reproducibility and determine which patients benefit most. Trial Registration ClinicalTrials.gov Identifiers: NCT05575128 , NCT05685511 , and NCT05697835
BACKGROUND:The Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) trial is a multicenter prospective, randomized comparative effectiveness trial examining patients' experiences and outcomes after receiving either total intravenous anesthesia with propofol or inhaled volatile anesthesia for general anesthesia (NCT05991453). Before the 13,000-patient trial, a pilot trial (NCT05346588) was performed to establish feasibility and determine the percentage of success of (1) patient enrollment, (2) intervention adherence, and (3) data completion. METHODS:This feasibility trial included adult patients undergoing elective noncardiac surgery requiring general anesthesia across two academic institutions in the United States. Patients were randomized to receive general anesthesia with total intravenous or inhalational anesthesia. Patients completed surveys on postoperative days 0, 1, 2, 7, 30, and 90. The percentages of consent, intervention adherence, and data completion were compared with predefined thresholds (10%, 80%, and 90%, respectively). RESULTS:A total of 300 patients were enrolled across two sites: Washington University in St. Louis (St. Louis, Missouri) and the University of Michigan (Ann Arbor, Michigan), from September 2022 through March 2023. The percentages achieved significantly exceeded predefined thresholds: 351 of 663 (53%; 95% CI, 49 to 57%) patients approached were successfully consented, adherence to the randomized intervention occurred in 142 of 149 (95%; 95% CI, 92 to 99%) total intravenous anesthesia cases and 150 of 151 (99%; 95% CI, 98 to 100%) inhaled cases, and complete data collection occurred in 279 of 299 (93%; 95% CI, 91 to 96%) patients for the Quality of Recovery-15 and 299 of 299 (100% complete 95% CI, 100 to 100%) patients for the modified Brice, the intraoperative awareness screening questionnaire. CONCLUSIONS:It was feasible to enroll sufficient patients, adhere strongly to the randomized treatment allocation, and obtain adequate outcomes data at these two pilot sites for the THRIVE trial.
BACKGROUND: Exploring participants’ experiences in comparative effectiveness anesthesia clinical trials offers valuable insights for improving trial design, conduct, and outcome measures while identifying factors that may hinder trial success. The challenges and opportunities of conducting comparative effectiveness trials are distinct from classic explanatory trials. To optimize and conduct a full-scale comparative effectiveness trial, we interviewed patients to identify barriers and facilitators to study participation and offer strategies to improve the recruitment and retention of participants in anesthesia comparative effectiveness clinical trials. METHODS: We conducted qualitative semi-structured interviews using constructs from the Consolidated Framework for Implementation Research. Interviews assessed barriers and facilitators to study participation in an anesthesia clinical trial comparing outcomes after receiving either total intravenous anesthesia (TIVA) or inhaled volatile anesthesia (INVA). Interview guides were co-developed with a multidisciplinary team, including patient partners, and addressed study participation, acceptability of the study procedures, and prior experiences with anesthesia. Participants were recruited at two large academic medical centers. Two coders used a standardized codebook to code each interview, achieving > 95% agreement. Interview transcripts were analyzed using thematic analysis. RESULTS: Ninety-one patients were approached, 43 agreed to participate, and 35 interviews were conducted until we reached thematic saturation. Patients found participation in the anesthesia research study to be positive, straightforward, and non-intrusive. Study-related barriers to enrollment and participation included survey language, blinding, randomization, and concerns for breach of confidentiality. Patient-related barriers included fear and mistrust of research and discomfort with technology. Study-related facilitators included the safety and non-experimental nature of both general anesthesia techniques, use of digital technology, minimal time burden, trust and clear communication by the study staff, and compensation. Patients were motivated to participate by altruistic values. Adaptable barriers were addressed, and solutions were implemented to improve study procedures and staff responsibilities, aimed at enhancing participation and ensuring positive experiences for patients in future anesthesia comparative effectiveness clinical trials. CONCLUSIONS: Key elements to consider when designing and conducting a comparative effectiveness anesthesia trial include promoting participant comfort and trust, ensuring clear communication, highlighting the safety and clinical equipoise of the trial comparators, supportive behaviors from the clinical team, minimizing time burden, and using simple-to-learn digital technology. Findings of this study were used to refine the full-scale pragmatic, comparative effectiveness, randomized controlled trial evaluating patient experiences with TIVA and INVA.
BACKGROUND:Postoperative opioid and benzodiazepine use often extends beyond recovery, yet research on surgical prescribing tends to focus on opioid-naive patients. Less is known about those already using these medications preoperatively, who face different risks and care needs. STUDY DESIGN:Using a national US claims database (PearlDiver, 2010 to 2022), we identified insured adults receiving 1 of 18 common surgeries. We examined patterns of filled prescriptions for opioids and benzodiazepines before and after surgery, including (1) opioids without benzodiazepines (opioid monotherapy), (2) benzodiazepines without opioids (benzodiazepine monotherapy), (3) exposure to both, and (4) exposure to neither. Preoperative prescriptions were assessed between 6 months and 1 week before surgery. Postoperative prescriptions between 1 and 3 months after surgery were assessed. Using multivariable logistic regression, we analyzed relationships between preoperative and postoperative opioid and benzodiazepine medication fills. RESULTS:Among 14.9 million adults, 62% and 80% were opioid- and benzodiazepine-naive preoperatively. Among opioid and benzodiazepine-naive patients, 21.4% initiated these medications postoperatively. In contrast, 51% of preoperative opioid and benzodiazepine users filled prescriptions after surgery. Although >80% of patients on preoperative benzodiazepine monotherapy no longer received benzodiazepines postoperatively, benzodiazepine monotherapy strongly predicted exposure to benzodiazepine monotherapy (adjusted odds ratio 24.10 [23.88 to 24.32]) and both opioid and BZDs (adjusted odds ratio 15.59 [15.51 to 15.88]). CONCLUSIONS:Postoperative prescribing may reflect patients' preexisting opioid and benzodiazepine use more than new surgical indications. Understanding these trajectories is key for developing surgery-specific interventions, especially for patients with preoperative opioid and benzodiazepine exposure.
Importance:Delirium is common after cardiac surgery and associated with adverse outcomes. Intraoperative benzodiazepines may increase postoperative delirium but restricting intraoperative benzodiazepines has not yet been evaluated in a randomized trial. Objective:To determine whether an institutional policy of restricted intraoperative benzodiazepine administration reduced the incidence of postoperative delirium. Design, Setting, and Participants:This pragmatic, multiperiod, patient- and assessor-blinded, cluster randomized crossover trial took place at 20 North American cardiac surgical centers. All adults undergoing open cardiac surgery at participating centers during the trial period were included through a waiver of individual patient consent between November 2019 and December 2022. Intervention:Institutional policies of restrictive vs liberal intraoperative benzodiazepine administration were compared. Hospitals (clusters) were randomized to cross between the restricted and liberal benzodiazepine policies 12 to 18 times over 4-week periods. Main Outcomes and Measures:The primary outcome was the incidence of delirium within 72 hours of surgery as detected in routine clinical care, using either the Confusion Assessment Method-Intensive Care Unit or the Intensive Care Delirium Screening Checklist. Intraoperative awareness by patient report was assessed as an adverse event. Results:During the trial, 19 768 patients (mean [SD] age, 65 [12] years; 14 528 [73.5%] male) underwent cardiac surgery, 9827 during restricted benzodiazepine periods and 9941 during liberal benzodiazepine periods. During restricted periods, clinicians adhered to assigned policy in 8928 patients (90.9%), compared to 9268 patients (93.2%) during liberal periods. Delirium occurred in 1373 patients (14.0%) during restricted periods and 1485 (14.9%) during liberal periods (adjusted odds ratio [aOR], 0.92; 95% CI, 0.84-1.01; P = .07). No patient spontaneously reported intraoperative awareness. Conclusions and Relevance:In intention-to-treat analyses, restricting benzodiazepines during cardiac surgery did not reduce delirium incidence but was also not associated with an increase in the incidence of patient-reported intraoperative awareness. Given that smaller effect sizes cannot be ruled out, restriction of benzodiazepines during cardiac surgery may be considered. Research is required to determine whether restricting intraoperative benzodiazepines at the patient level can reduce the incidence of postoperative delirium. Trial Registration:ClinicalTrials.gov Identifier: NCT03928236.
BackgroundMeasles-containing vaccines (MCV), by training innate immune cells, are hypothesized to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19).MethodsIn this international, double-blind, placebo-controlled trial, we randomly assigned adults, 18 years and older, to receive MCV or saline. The primary outcome was polymerase chain reaction (PCR) confirmed symptomatic COVID-19, up to 60 days after intervention. Secondary outcomes were PCR-confirmed symptomatic COVID-19 and serologically confirmed SARS-CoV-2 infection, up to 150 days after intervention.ResultsOf 3411 randomised participants, the modified intention-to-treat population included 1607 in the MCV and 1545 in the saline group. The estimated risk of symptomatic COVID-19 by 60 days was 1.5% in the MCV and 1.2% in the saline group (risk difference, 0.3 percentage points, 95% CI, -0.5 to 1.1; p=0.52). At 150 days, these percentages were 4.1% (65/1585) and 4.1% (64/1544) in the MCV and saline groups, respectively (risk difference, 0.04 percentage points, 95% CI, -1.4 to 1.3; p=0.95). Based on serology results available at 0 and 150 days, 10.6% (100/945) of participants in the MCV and 10.3% (98/951) in the saline group had infection with SARS-CoV-2 over the course of the trial (risk difference, 0.3 percentage points, 95% CI, -2.6 to 3.1; p=0.84). Three patients were hospitalised with COVID-19 disease in the MCV and one in the saline group.ConclusionsAdministering MCVs to stimulate trained immunity did not prevent COVID-19 or SARS-CoV2 infection. Stimulating trained immunity might not be useful for preventing respiratory illness during future pandemics.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT04333732.
Background: Post-operative delirium (POD), characterized by an acute and fluctuating disturbance in mental status, is a common complication following surgery. Cardiac surgery, older adults, and those with anxiety or depression symptoms are especially vulnerable groups, yet few studies have evaluated the role of perioperative mental health interventions or examined the incidence and correlates of POD in this high-risk population. Research Question: What is the incidence and what are the correlates of POD in older adult surgical patients with symptoms of anxiety and/or depression prior to surgery, and how do these compare between cardiac and non-cardiac surgeries? Methods: This single-site randomized controlled trial (PMID:38569683) included 306 patients receiving cardiac (n=102), orthopedic (n=104), or oncologic surgery (n=100) aged ≥60 years with clinically significant anxiety and/or depression. Exclusion criteria included non-English speakers, severe cognitive impairment, and active suicidal ideation. POD was identified using the validated Chart-based Delirium Identification Instrument (CHART-DEL). Descriptive statistics were used to determine POD incidence and characterize the sample. Logistic regression analyses explored demographic predictors of POD. Results: The sample had a mean age of 68.5 years (SD=6), was 68.3% female (n=209), and predominantly white (85%, n=260). Overall, 13.7% (n=42) screened positive for POD. POD incidence varied significantly by surgical cohort: 33% (n=34) in the cardiac cohort, compared to 6% (n=6) in the oncologic cohort and 2% (n=2) in the orthopedic cohort. Among cardiac patients, open procedures were associated with significantly higher POD rates (55%, n=32) compared to interventional procedures (5%, n=2) (p<.001). Education level and surgery type were significant predictors of POD. Greater education attainment was associated with reduced POD risk (OR=.813; 95%CI: 0.681, 0.970; p=.022). Marital status showed a non-significant trend toward a protective effect (OR=.456 95%CI: 0.204, 1.02; p=.056). Conclusion: Older adults with anxiety and/or depression symptoms undergoing cardiac surgery, particularly open procedures, are at elevated risk for POD. Higher educational attainment appears to confer a protective effect, potentially via increased cognitive reserve. These findings emphasize the need for targeted perioperative mental health strategies in high-risk surgical populations.
OBJECTIVE:The primary objective was to evaluate agreement between researchers' and family members' postoperative delirium assessment. The secondary objective was to assess the incidence of positive FAM-CAM after hospital discharge up to 30-days postoperatively. METHODS:This was a pre-specified sub-study of two multicenter randomized controlled trials that evaluated interventions to prevent postoperative delirium in older adults undergoing major elective surgery. In the hospital, delirium was ascertained using the Confusion Assessment Method (CAM) long-form or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), and structured chart review. Family members completed a Family Confusion Assessment Method (FAM-CAM) concurrent with researchers' assessments in the afternoons on postoperative days 1-3. At the time of hospital discharge, a booklet of FAM-CAM surveys was provided to complete daily until postoperative day 30. Agreement between researcher-rated CAM/CAM-ICU and family-rated FAM-CAM was analyzed using Generalized Linear Mixed Model with repeated measures, and Bland-Altman analysis. Inter-rater reliability for each instrument was modeled using intraclass correlation coefficient (ICC). Overall agreement beyond chance between researcher's assessment and the FAM-CAM was evaluated using repeated measure Cohen's Kappa and sensitivity, specificity, and positive and negative predicted values. Post-discharge FAM-CAM data were summarized descriptively. RESULTS:A total of 817 patients had 1349 concurrent delirium assessments. Postoperative delirium incidence by researchers' assessment was 18.8 % and detection of delirium symptoms by FAM-CAM was 22.4 %. Analysis comparing delirium assessments showed there is an observed agreement beyond chance of 79.7 % with a kappa of 0.33 between the assessments by Generalized Linear Mixed Modeling with repeated measures, treating patients and raters as random effects, with FAM-CAM being more likely to report a positive delirium outcome. Assessment by features showed similar results. Both methods had an excellent degree of internal validity (CAM/CAM-ICU intraclass correlation =0.938, FAM-CAM intraclass correlation = 0.985). Repeated measures Cohen's kappa indicated good overall agreement (kappa = 0.72 [95 % confidence interval, 0.63 to 0.81]). Of the 330 booklets, 133 (40.3 %) were returned. A total of 18 patients exhibited symptoms indicative of delirium based on the FAM-CAM assessment between hospital discharge and 30 days postoperatively. Out of these, 9 (50 %) had also been diagnosed with postoperative delirium during their hospitalization. CONCLUSION:This study demonstrated that family member completed FAM-CAM had acceptable agreement with researchers' delirium assessments. Postoperative delirium symptoms were detected more frequently by family-administered FAM-CAM compared to delirium incidence identified by researcher assessments. Family members identified that some patients experienced delirium symptoms after hospital discharge.
Importance Accurate estimation of surgical transfusion risk is important for perioperative planning and effective resource allocation. Most machine learning models in health care are not validated or perform poorly in external settings. Objective To externally validate a publicly available machine learning algorithm (Surgical Personalized Anticipation of Transfusion Hazard [S-PATH]) to estimate red cell transfusion during surgery within a national sample of hospitals. Design, Setting, and Participants This retrospective cohort study evaluated all surgical cases performed in 2020 or 2021 at 45 US hospitals participating in the Multicenter Perioperative Outcomes Group. Obstetric and nonoperative cases were excluded. Data analysis was performed from February 2023 to March 2025. Exposures At each hospital, S-PATH was used to estimate surgical transfusion risk using patient- and procedure-specific characteristics without local retraining. A baseline model representing the standard-of-care maximum surgical blood ordering schedule (MSBOS) approach, which omits patient factors, was used for comparison. Risk thresholds above which a type and screen would be recommended were set for 96% sensitivity. Performance was evaluated at each hospital separately. Main Outcomes and Measures The primary outcome was the difference in the percentage of patients with type and screen order recommendations between S-PATH and MSBOS at each hospital. The secondary outcome was area under the receiver operating characteristic curve (AUROC). Results In this cohort study of 3 275 956 surgical cases (median [IQR] age, 57 [40-69] years; 53.1% female) performed at 45 hospitals (28 of 45 academic [62.2%]), S-PATH recommended type and screen orders for a median (IQR) of 32.5% (25.8%-42.0%) of cases, whereas the MSBOS approach recommended type and screens for a median (IQR) of 51.6% (46.9%-61.1%) of cases for the same sensitivity (median [IQR] difference, 17.9 [14.8-24.9] absolute percentage points). The median (IQR) S-PATH AUROC was 0.929 (0.915-0.946), whereas the median (IQR) MSBOS AUROC was 0.857 (0.822-0.884). Conclusions and Relevance In this cohort study of 45 hospitals, a personalized surgical transfusion risk prediction algorithm demonstrated external validity and discrimination. S-PATH was consistently more effective than standard care, suggesting its potential for use as a perioperative clinical decision support tool.
INTRODUCTION:Oncologic surgeries are common and rates of depression and anxiety are high in the peri-operative period, potentially interfering with successful recovery. METHODS:We conducted a narrative review and meta-analysis focusing on randomised controlled trials evaluating the effect of peri-operative mental health interventions on anxiety and/or depression in adult patients having oncological surgery. The review included studies published in the last 5 years, identified through EMBASE with no pre-specified criteria for the type of comparison or outcome. A meta-analysis using a random effects model was performed for outcomes with sufficient data, and a vote-counting synthesis was performed for studies with insufficient data or fewer than two studies per outcome. RESULTS:Seventeen randomised controlled trials were included. All were conducted internationally, primarily in Asia. Ten studies assessed psychological interventions (e.g. cognitive behavioural therapy), six assessed pharmacological interventions (e.g. ketamine) and one assessed acupuncture. Meta-analysis revealed significant intervention effects on pre-operative anxiety scores (n = 429, Hedge's g = -1.03, p = 0.001) and postoperative depression scores at hospital discharge (n = 188, Hedge's g = -0.88, p < 0.001), whereas no significant intervention effect was found in anxiety scores at discharge (n = 188, Hedge's g = -1.54, p = 0.08). Vote-counting synthesis identified intervention effects on depression and anxiety scores on day 3 postoperatively and on depression scores at one-week postoperatively, while all other time-points showed no intervention effect. DISCUSSION:Psychological and pharmacological interventions are effective at reducing pre-operative anxiety and immediate postoperative depression scores in patients having oncological surgery, but these benefits do not persist postoperatively. Hence, future research efforts should focus on development and testing of interventions that are effective and implementable within the peri-operative context.
INTRODUCTION:Millions of patients receive general anaesthesia every year with either propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA). It is currently unknown which of these techniques is superior in relation to patient experience, safety and clinical outcomes. The primary aims of this trial are to determine (1) whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and (2) whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA. METHODS AND ANALYSIS:This protocol was co-created by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 13 000-patient, multicentre, patient-blinded, randomised, comparative effectiveness trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to one of two anaesthetic approaches, TIVA or INVA, using minimisation. The primary effectiveness endpoints are Quality of Recovery-15 (QOR-15) score on postoperative day (POD) 1 in patients undergoing (1) major inpatient surgery, (2) minor inpatient surgery or (3) outpatient surgery, and the primary safety endpoint is the incidence of unintended definite intraoperative awareness with recall in all patients, assessed on POD1 or POD30. Secondary endpoints include QOR-15 score on POD0, POD2 and POD7; incidence of delirium on POD0 and POD1; functional status on POD30 and POD90; health-related quality of life on POD30, POD90, POD180 and POD365; days alive and at home at POD30; patient satisfaction with anaesthesia at POD2; respiratory failure on POD0; kidney injury on POD7; all-cause mortality at POD30 and POD90; intraoperative hypotension; moderate-to-severe intraoperative movement; unplanned hospital admission after outpatient surgery in a free-standing ambulatory surgery centre setting; propofol-related infusion syndrome and malignant hyperthermia. ETHICS AND DISSEMINATION:This study is approved by the ethics board at Washington University, serving as the single Institutional Review Board for all participating sites. Recruitment began in September 2023. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media. TRIAL REGISTRATION NUMBER:NCT05991453.
IntroductionHip fractures may result from and contribute to accelerated biological aging. We aimed to evaluate the impact of hip fracture and its surgery on the senescence-associated secretory phenotype (SASP) index, a composite of peripheral protein markers where higher scores are thought to indicate greater levels of cellular senescence and accelerated aging.MethodsWe examined the SASP index in plasma over 12 weeks post-surgery and its prediction of long-term post-surgical functional outcomes. We included 60 older adults: 20 recruited immediately after hip fracture surgery, and 40 comparison individuals who were either healthy or suffering chronic psychosocial stress (caregiving). We assessed 22 SASP biomarkers and calculated the SASP index score for each hip fracture participant immediately following fracture surgery and 4 and 12 weeks later. Functional recovery was assessed at 12, 26, and 52 weeks after hip replacement surgery.ResultsThe hip fracture group had higher SASP index scores than the comparison groups, after adjusting for potential confounding variables (p = 0.021). SASP index scores in hip fracture patients increased further by week 4 after surgery (p < 0.001), declining by week 12 but remaining elevated overall. However, the SASP index scores were not significantly associated with functional recovery after hip replacement surgery at 26 or 52 weeks after surgery. In conclusion, after hip fracture surgery SASP scores are elevated, continue to rise over time, and do not return to normal by 12 weeks post-surgery.DiscussionOur findings support the need to investigate this phenomenon of post-operative senescence, including whether novel interventions such as senolytics would help older adults facing major surgery.
Background: The objective of this study was to determine whether postoperative pager alerts to the Hospital Elder Life Program (HELP), a delirium prevention service, would accelerate program enrollment for older surgical patients. This study also tested feasibility of family care partner interventions for delirium prevention. Methods: This single-center, pilot clinical trial factorially randomized 57 non-cardiac surgical patients ≥70 years of age to 4 arms: (1) standard care, (2) pager alerts to accelerate HELP enrollment, (3) family care partner-based delirium prevention interventions, or (4) a combined arm with both HELP and family interventions. The primary clinical outcome was delirium (assessed through the Confusion Assessment Method). Results: In the pager alerting arms, 13/24 (54%) participants were enrolled by HELP on postoperative day 1 compared with 0/26 (0%, P<0.001) in the non-alerting arms. Median [interquartile range] time spent in delirium prevention protocols was significantly longer in pager alerting arms than in non-alerting arms (39 [5 to 75] min vs. 0 [0 to 0] min; P<0.001). Family care partners spent 18 [11 to 25)] hours at the bedside over the first 3 postoperative days. There was no significant difference in delirium occurrence in participants randomized to pager alert arms compared with non-alerting arms (odds ratio, 1.02, 95% CI, 0.97-1.07; P=0.390). Similarly, there was no significant difference in delirium occurrence in family intervention arms compared with nonintervention arms (odds ratio, 0.97; 95% CI 0.93-10.02; P=0.270). Conclusions: Pager alerts significantly reduced time to HELP enrollment, albeit without reducing delirium incidence in this pilot study. Family care partners spent substantial time at the bedside during the study period.
OBJECTIVES:Perioperative mental health of older Black surgical patients is associated with poor surgical outcomes; however, evidence-based perioperative interventions are lacking. Our two study objectives included: first, examine factors affecting perioperative care experiences of older Black surgical patients with mental health problems, and second, ascertain design and implementation requirements for a culturally-adapted perioperative mental health intervention. DESIGN SETTING AND PARTICIPANTS:We conducted six focus groups with older Black patients (n = 15; ≥50 years; surgery within the past 5 years and/or interest in mental health research; history of distress, anxiety, or depression coping with surgery/hospitalization/) from a large academic medical center. We engaged study partners, including interventionists and community members, to gather insights on intervention and implementation needs. We followed a hybrid inductive-deductive thematic approach using open coding and the National Institute on Minority Health and Health Disparities Research Framework. RESULTS:Patients reported that their psychological well-being and long-term mental health outcomes were not appropriately considered during perioperative care. Perceived stressors included interpersonal and structural barriers to using mental healthcare services, clinician treatment biases and ageism in care, and lack of healthcare professional connections/resources. Patients utilized various coping strategies, including talk therapy, faith/spirituality, and family and friends. CONCLUSION:This study offers valuable insights into the experiences of older Black surgical patients and the critical elements for developing a personalized perioperative mental health intervention to support their well-being before, during, and after surgery. Our findings demonstrated a need for a patient-centered and culturally adapted intervention targeting the individual/behavioral and interpersonal levels. Informed by the cultural adaptation framework, we propose a multi-component intervention that integrates psychological and pharmacological components.
Importance Intraoperative electroencephalogram (EEG) waveform suppression, suggesting excessive general anesthesia, has been associated with postoperative delirium. Objective To assess whether EEG-guided anesthesia decreases the incidence of delirium after cardiac surgery. Design, Setting, and Participants Randomized, parallel-group clinical trial of 1140 adults 60 years or older undergoing cardiac surgery at 4 Canadian hospitals. Recruitment was from December 2016 to February 2022, with follow-up until February 2023. Interventions Patients were randomized in a 1:1 ratio (stratified by hospital) to receive EEG-guided anesthesia (n = 567) or usual care (n = 573). Patients and those assessing outcomes were blinded to group assignment. Main Outcomes and Measures The primary outcome was delirium during postoperative days 1 through 5. Intraoperative measures included anesthetic concentration and EEG suppression time. Secondary outcomes included intensive care and hospital length of stay. Serious adverse events included intraoperative awareness, medical complications, and 30-day mortality. Results Of 1140 randomized patients (median [IQR] age, 70 [65-75] years; 282 [24.7%] women), 1131 (99.2%) were assessed for the primary outcome. Delirium during postoperative days 1 to 5 occurred in 102 of 562 patients (18.15%) in the EEG-guided group and 103 of 569 patients (18.10%) in the usual care group (difference, 0.05% [95% CI, -4.57% to 4.67%]). In the EEG-guided group compared with the usual care group, the median volatile anesthetic minimum alveolar concentration was 0.14 (95% CI, 0.15 to 0.13) lower (0.66 vs 0.80) and there was a 7.7-minute (95% CI, 10.6 to 4.7) decrease in the median total time spent with EEG suppression (4.0 vs 11.7 min). There were no significant differences between groups in median length of intensive care unit (difference, 0 days [95% CI, -0.31 to 0.31]) or hospital stay (difference, 0 days [95% CI, -0.94 to 0.94]). No patients reported intraoperative awareness. Medical complications occurred in 64 of 567 patients (11.3%) in the EEG-guided group and 73 of 573 (12.7%) in the usual care group. Thirty-day mortality occurred in 8 of 567 patients (1.4%) in the EEG-guided group and 13 of 573 (2.3%) in the usual care group. Conclusions and Relevance Among older adults undergoing cardiac surgery, EEG-guided anesthetic administration to minimize EEG suppression, compared with usual care, did not decrease the incidence of postoperative delirium. This finding does not support EEG-guided anesthesia for this indication.
Introduction: Previous studies suggest an association between cognitive flexibility and development of chronic pain after surgery. It is not known whether cognitive flexibility can be improved in patients with chronic pain. Objectives: This study tested whether a neurocognitive training program results in improved cognitive flexibility and pain in patients with chronic pain. Methods: We conducted a single-center, prospective, randomized study investigating 5-week daily neurocognitive training in patients with chronic pain. Participants (n = 145) were randomized into neurocognitive training or care as usual, and they completed assessments at baseline, posttreatment, and 3 months. The treatment group was asked to spend 35 minutes daily completing a program with tasks on cognitive flexibility, memory, attention, and speed. The primary outcome was performance on the neurocognitive performance test (NCPT). Secondary outcomes included levels of pain interference and severity. Results: At 5 weeks, the treatment group showed greater improvements on NCPT compared with the control group (d = 0.37); effect size was smaller at 3 months (d = 0.18). The treatment group reported lower pain severity at 5 weeks (d = 0.16) and 3 months (d = 0.39) than the control group, but pain interference was only lower at 3 months (d = 0.20). Conclusions: Outcomes suggest that using neurocognitive training to modify cognitive flexibility in patients with chronic pain may improve pain severity. This study provided effect size estimates to inform sample size calculations for randomized controlled trials to test the effectiveness of neurocognitive interventions for the prevention and treatment of chronic pain.