Telemedicine for Preanesthesia Consultations During the First COVID-19 Lockdown.

Introduction: In an effort to avoid travel and interpersonal contact, the COVID-19 health crisis was an opportunity to offer preanesthesia teleconsultation (TCs) to patients scheduled for surgery. Materials and Methods: We studied the technical feasibility and patient experiences of these TCs using a 4-point Likert scale questionnaire. Results: Eighty-six patients out of 139 responded. Technical difficulties (no connection, picture, or sound) occurred in 24% of cases. The patient's experience was considered very positive both in terms of feelings and understanding instructions: 4 (4-4). No deprogramming was required. Conclusion: TCs were approved by patients despite technical problems. Further studies are required to ensure that this type of consultation is not inferior to face-to-face consultations. NCT04920604.

Comparison of continuous with single-injection regional analgesia on patient experience after ambulatory orthopaedic surgery: a randomised multicentre trial.

BACKGROUND: The optimal approach to improving patient experience and analgesia after ambulatory orthopaedic surgery remains unclear. METHODS: This multicentre, randomised clinical trial compared single-injection nerve block analgesia with home delivery of continuous nerve block analgesia by remote-controlled electronic pump. The primary outcome was patient-reported satisfaction (Evaluation du Vecu de l'Anesthesie Generale [EVAN-G]; 0-100) assessed on postoperative Day 2. Secondary outcomes focused on pain, opioid consumption, quality of rehabilitation, activity tracking using a wearable electronic device, and 90-day quality of life. RESULTS: We randomly assigned 294 patients to continuous pump delivery or single injection. For subjects with normal level of pain catastrophising (Pain Catastrophizing Scale <30; n=211), median global EVAN-G was higher with the electronic pump compared with the single injection (78 [69-86] vs 72 [63-84]; P=0.03), as were pain satisfaction scores (P=0.01). For the maximum pain levels, the numerical rating scale score was 2.0 (1.0-5.0) in the electronic-pump group vs 5.0 (3.0-7.0) in the single-injection group on the first 2 days after surgery (P<0.0001). Total opioid consumption in morphine equivalent was higher with single injection (mean [standard deviation]): 70.5 [73.8] vs 31.9 [54.2] mg; P<0.01). The groups did not differ in early rehabilitation on Day 1 or quality of life on Day 45. Electronic activity tracking indicated higher activity in the electronic-pump group (P<0.01). CONCLUSIONS: Self-reported patient satisfaction at home was better with continuous nerve block analgesia via electronic pump vs single injection, without impairing early rehabilitation. Single-injection analgesia was associated with higher pain levels and opioid consumption and lower satisfaction. Patient catastrophising negatively affected the experience of pain. CLINICAL TRIAL REGISTRATION: NCT02720965.

Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial.

BACKGROUND: Pectoral nerve blocks have been proposed for analgesia during and after breast cancer surgery, but data are conflicted in aesthetic breast surgery. This trial tested the primary hypothesis that adding a preincisional pectoral nerve block is superior to systemic multimodal analgesic regimen alone for pain control after breast augmentation surgery. A second hypothesis is that rescue opioid consumption would be decreased with a long-lasting effect for both outcomes during the following days. METHODS: Seventy-three adult female patients undergoing aesthetic breast augmentation surgery under general anesthesia were randomly allocated to receive a pectoral nerve block versus no block. Both groups received standard care with protocolized multimodal analgesia alone including systematic acetaminophen and nonsteroidal anti-inflammatory drugs. The primary outcome measure was the maximal numerical rating scale in the first 6 h after extubation. Secondary outcomes included intraoperative remifentanil consumption and from extubation to day 5: maximal numerical rating scale, postoperative cumulative opioid consumption and postoperative opioid side effects, and patient satisfaction recorded at day 5. RESULTS: The maximal numerical rating scale score in the first 6 h was lower in the pectoral nerve block group compared with the control group (3.9 ± 2.5 vs. 5.2 ± 2.2; difference: -1.2 [95% CI, -2.3 to -0.1]; P = 0.036). The pectoral nerve block group had a lower maximal numerical rating scale between days 1 and 5 (2.2 ± 1.9 vs. 3.2 ± 1.7; P = 0.032). The cumulative amount of overall opioids consumption (oral morphine equivalent) was lower for the pectoral nerve block group from hour 6 to day 1 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 31.5] mg, P = 0.006) and from days 1 to 5 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 51] mg, P = 0.002). CONCLUSIONS: Pectoral nerve block in conjunction with multimodal analgesia provides effective perioperative pain relief after aesthetic breast surgery and is associated with reduced opioid consumption over the first 5 postoperative days.

Balanced Opioid-free Anesthesia with Dexmedetomidine versus Balanced Anesthesia with Remifentanil for Major or Intermediate Noncardiac Surgery.

BACKGROUND: It is speculated that opioid-free anesthesia may provide adequate pain control while reducing postoperative opioid consumption. However, there is currently no evidence to support the speculation. The authors hypothesized that opioid-free balanced anesthetic with dexmedetomidine reduces postoperative opioid-related adverse events compared with balanced anesthetic with remifentanil. METHODS: Patients were randomized to receive a standard balanced anesthetic with either intraoperative remifentanil plus morphine (remifentanil group) or dexmedetomidine (opioid-free group). All patients received intraoperative propofol, desflurane, dexamethasone, lidocaine infusion, ketamine infusion, neuromuscular blockade, and postoperative lidocaine infusion, paracetamol, nefopam, and patient-controlled morphine. The primary outcome was a composite of postoperative opioid-related adverse events (hypoxemia, ileus, or cognitive dysfunction) within the first 48 h after extubation. The main secondary outcomes were episodes of postoperative pain, opioid consumption, and postoperative nausea and vomiting. RESULTS: The study was stopped prematurely because of five cases of severe bradycardia in the dexmedetomidine group. The primary composite outcome occurred in 122 of 156 (78%) dexmedetomidine group patients compared with 105 of 156 (67%) in the remifentanil group (relative risk, 1.16; 95% CI, 1.01 to 1.33; P = 0.031). Hypoxemia occurred 110 of 152 (72%) of dexmedetomidine group and 94 of 155 (61%) of remifentanil group patients (relative risk, 1.19; 95% CI, 1.02 to 1.40; P = 0.030). There were no differences in ileus or cognitive dysfunction. Cumulative 0 to 48 h postoperative morphine consumption (11 mg [5 to 21] versus 6 mg [0 to 17]) and postoperative nausea and vomiting (58 of 157 [37%] versus 37 of 157 [24%]; relative risk, 0.64; 95% CI, 0.45 to 0.90) were both less in the dexmedetomidine group, whereas measures of analgesia were similar in both groups. Dexmedetomidine patients had more delayed extubation and prolonged postanesthesia care unit stay. CONCLUSIONS: This trial refuted the hypothesis that balanced opioid-free anesthesia with dexmedetomidine, compared with remifentanil, would result in fewer postoperative opioid-related adverse events. Conversely, it did result in a greater incidence of serious adverse events, especially hypoxemia and bradycardia.

Post-operative opioid-related adverse events with intravenous oxycodone compared to morphine: A randomized controlled trial.

BACKGROUND: The value of intravenous oxycodone compared to morphine remains controversial. The purpose of this trial was to compare opioid-related adverse events (ORAES) of intravenous oxycodone and morphine after total hip arthroplasty. METHODS: Patients scheduled for total hip arthroplasty were enrolled in this study of post-operative pain treatment with intravenous oxycodone or intravenous morphine (ratio 1:1). After surgery, patients received similar drug regimens for titration in the post-operative care unit followed by intravenous patient-controlled analgesia (PCA). The primary outcome was the number of patients with ≥1 ORAEs within the first 24 hours defined as either nausea, vomiting, respiratory depression, pruritus, urinary retention requiring evacuation, allergy, hallucinations. Secondary outcomes included pain scores and opioid consumption. RESULTS: The analysis included 238 patients with similar characteristics. There were 55 patients with at least one ORAEs in the oxycodone group vs 46 in the morphine group: 48% vs 40%, P = .19; relative risk = 1.22 (0.91:1.63). Intravenous oxycodone vs intravenous morphine requirements were respectively (median, IQR): 6 (0-11) vs 8 (0-12) mg (P = .06) for titration, 15 (8-26) vs 8 (5-16) mg (P = .001) for PCA, and 22 (12-37) mg vs 19 (11-28) mg for cumulated intravenous consumption (P = .048). During the first 24 hours, there was no difference in secondary outcomes (oxycodone vs morphine, respectively, in %): nausea (15 vs 13), vomiting (5 vs 5), urinary retention (20 vs 12) or pain scores. CONCLUSION: This study demonstrates that IV oxycodone did not significantly reduce ORAEs within the first 24 hours compared to similar ratio of IV morphine.

Multimodal oral analgesia strategy after ambulatory arthroscopic shoulder surgery: case series using adaptive therapeutic approaches by sequential analysis.

BACKGROUND: Pain control and quality of recovery (QoR) at home remains a challenge after ambulatory shoulder arthroscopy. This study aims to assess the QoR and pain relief using a sequential implementation strategy for rescue analgesic drugs. METHODS: After institutional review board approval, patients (>18 years, American Society of Anesthesiology [ASA] score 1-3 stable) scheduled for ambulatory surgery under general anesthesia with a single-shot interscalene nerve block were enrolled. After discharge, patients received standard information regarding the postoperative recovery and care consisting of a multimodal analgesic regime (acetaminophen and ketoprofen for 5 days). The first 48 postoperative hours allowed us to compare 3 different rescue drug regimes with a control group, in sequential order: tramadol (control group), tramadol + nefopam, immediate-release oxycodone (IR), and extended-release oxycodone (ER). The primary endpoint was the QoR 40 score at 48 hours after surgery. Secondary endpoints were pain relief and adverse events over a 7-day period. An intention-to-treat statistical analysis was performed with sequential analysis (as an interim analysis) every 20 patients. Results were recorded as medians and interquartiles (25-75). RESULTS: We analyzed 109 patients with similar characteristics among groups. The QoR 40 scores were similar for the tramadol group (168 [161-172]), the tramadol + nefopam group (161 [151-173], P = .09), and the IR group (164 [153-169], P = .17), but higher for the ER group (176 [167-181], P = .03). Concerning adverse events, drugs were interrupted more frequently in the tramadol + nefopam group (36 %). In the ER group, a higher quality of postoperative relief was attained in the domains of pain and sleep. CONCLUSION: The present study shows that a combination of IR and ER oxycodone over a short period of time (<48 hours) is associated with a better QoR at home after ambulatory shoulder surgery.

Magnetic needle-tracking device for ultrasound guidance of radial artery puncture: A randomized study on a simulation model.

INTRODUCTION: Ultrasound-guidance of radial artery catheter insertion improves the first attempt success and reduces the occurrence of hematomas. Needle-tracking devices optimize needle-ultrasound beam alignment by displaying in real-time the needle tip position. We compared the median time need by experienced physicians to achieve radial artery puncture using either a conventional ultrasonography device (CUD) or a magnetic needle-tracking ultrasound device (MUD) in a simulation training arm model. METHODS: Fifty experienced residents and physicians performed two punctures in randomized order with the CUD and the MUD. The primary outcome was puncture duration; the secondary outcomes were puncture success, rate of accidental vein puncture, and practitioner's comfort (subjective scale 0-10). RESULTS: The median [lower-upper quartile] puncture time was 10 [6-14] seconds when using CUD and 4 [3-7] seconds when using MUD (P < .01). In the multivariate analysis, MUD use was associated with decreased puncture duration whatever the puncture order (OR 1.13 [1.07-1.20], P < .01). The participants performed 99 (99%) successful punctures: 50 with the MUD (100%) and 49 with the CUD (98%). There was no accidental venous puncture. The practitioner's comfort level was 6.5 [6, 7] with the CUD and 8 [7-9] with the MUD (P < .01). CONCLUSION: MUD reduced radial artery puncture time and improved physician comfort in a simulation training arm model.

Feasibility of remote digital monitoring using wireless Bluetooth monitors, the Smart Angel™ app and an original web platform for patients following outpatient surgery: a prospective observational pilot study.

BACKGROUND: Remote monitoring of mean arterial blood pressure (MAP), heart rate (HR) or oxygen saturation (SpO2) remains a challenge in outpatient surgery. This study evaluates a new digital technology (Smart Angel™) for remotely monitoring hemodynamic data in real time: data transmitted from the patient's home to a central server, using a dedicated web-based software package. METHODS: Adults scheduled for elective outpatient surgery were prospectively enrolled. In the first 5 postoperative days, patients completed a self-report questionnaire (pain, comfort, nausea, vomiting) and recorded SpO2, HR and MAP via two wireless Bluetooth monitors connected to a 4G tablet to transmit the data to a website, in real time, using Smart Angel™ software. Before transmission to the website, these data were also self-reported by the patient on a paper form. The primary outcome was the proportion of variables (self-monitored physiological data + questionnaire scores) correctly transmitted to the hospital via the system compared with the paper version. On Day 5, a system usability scale survey (SUS score 1-100) was also attributed. RESULTS: From May 2018 to September 2018, data were available for 29 out of 30 patients enrolled (1 patient was not discharged from hospital after surgery). The remote monitoring technology recorded 2038 data items (62%) compared with 2656 (82%) items recorded on the paper form (p = 0.001). The most common errors with the remote technology were software malfunctioning when starting the MAP monitor and malfunctioning between the tablet and the Bluetooth monitor. No serious adverse events were noted. The SUS score for the system was 85 (68-93) for 26 patients. CONCLUSION: This work evaluates the ability of a pilot system for monitoring remote physiological data using digital technology after ambulatory surgery and highlights the digital limitations of this technology. Technological improvements are required to reduce malfunctioning (4G access, transmission between apps). TRIAL REGISTRATION: ClinicalTrials.gov ( NCT03464721 ) (March 8, 2018).

Impact of a preoperative pharmaceutical consultation in scheduled orthopedic surgery on admission: a prospective observational study.

BACKGROUND: Medication errors have a high prevalence in surgery and management of home medication is strongly involved in these errors. In scheduled surgery, the preoperative consultation is a privileged time to inform the patient about the management of her/his home medication before admission. This study assessed the impact of a pre-anesthesia best possible medication history (PA-BPMH) on admission. The PA-BPMH was performed by a clinical pharmacist prior to the anesthesia consultation for anesthesiologists to prescribe admission medical orders for scheduled orthopedic surgery patients. METHODS: This was a prospective observational study which was carried out in an orthopedic surgery department. All patients over 18 years old with an elective orthopedic surgery were eligible except ambulatory surgery patients. The pharmacist registered the PA-BPMH into the software making it available for anesthesiologists for the pre-admission medication order. Finally, a medication reconciliation was performed at admission. The main outcome was the percentage of patients with at least one unintended medication discrepancy (UMD) at admission. The nature, potential clinical impact and acceptance rate of each UMD detected were assessed. Also, the PA-BPMH process was described and patients and anesthesiologists satisfaction was evaluated. RESULTS: A total of 455 patients had a pharmaceutical consultation. Medication reconciliation was performed at admission for 360 patients. Overall, at least one UMD was observed in 13.0% of patients (n = 47). A total of 63 UMD were detected. The most common type of UMD was omission (25.4%) and incorrect drug (23.8%).Two UMD (3.2%) were evaluated as life threatening. All the UMD detected were corrected on the admission medication order. CONCLUSION: A preoperative pharmacist-anesthesiologist teamwork seems to improve the safety of perioperative management of home medication for scheduled orthopedic surgery patients. This process needs a randomized clinical trial across a wider range of surgeries before its implementation.

Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial.

Importance: It is not known if use of colloid solutions containing hydroxyethyl starch (HES) to correct for intravascular deficits in high-risk surgical patients is either effective or safe. Objective: To evaluate the effect of HES 130/0.4 compared with 0.9% saline for intravascular volume expansion on mortality and postoperative complications after major abdominal surgery. Design, Setting, and Participants: Multicenter, double-blind, parallel-group, randomized clinical trial of 775 adult patients at increased risk of postoperative kidney injury undergoing major abdominal surgery at 20 university hospitals in France from February 2016 to July 2018; final follow-up was in October 2018. Interventions: Patients were randomized to receive fluid containing either 6% HES 130/0.4 diluted in 0.9% saline (n = 389) or 0.9% saline alone (n = 386) in 250-mL boluses using an individualized hemodynamic algorithm during surgery and for up to 24 hours on the first postoperative day, defined as ending at 7:59 am the following day. Main Outcomes and Measures: The primary outcome was a composite of death or major postoperative complications at 14 days after surgery. Secondary outcomes included predefined postoperative complications within 14 days after surgery, durations of intensive care unit and hospital stays, and all-cause mortality at postoperative days 28 and 90. Results: Among 826 patients enrolled (mean age, 68 [SD, 7] years; 91 women [12%]), 775 (94%) completed the trial. The primary outcome occurred in 139 of 389 patients (36%) in the HES group and 125 of 386 patients (32%) in the saline group (difference, 3.3% [95% CI, -3.3% to 10.0%]; relative risk, 1.10 [95% CI, 0.91-1.34]; P = .33). Among 12 prespecified secondary outcomes reported, 11 showed no significant difference, but a statistically significant difference was found in median volume of study fluid administered on day 1: 1250 mL (interquartile range, 750-2000 mL) in the HES group and 1500 mL (interquartile range, 750-2150 mL) in the saline group (median difference, 250 mL [95% CI, 83-417 mL]; P = .006). At 28 days after surgery, 4.1% and 2.3% of patients had died in the HES and saline groups, respectively (difference, 1.8% [95% CI, -0.7% to 4.3%]; relative risk, 1.76 [95% CI, 0.79-3.94]; P = .17). Conclusions and Relevance: Among patients at risk of postoperative kidney injury undergoing major abdominal surgery, use of HES for volume replacement therapy compared with 0.9% saline resulted in no significant difference in a composite outcome of death or major postoperative complications within 14 days after surgery. These findings do not support the use of HES for volume replacement therapy in such patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02502773.

Outcomes and risk factors of transfusion-associated circulatory overload: a case control study.

BACKGROUND: Transfusion-associated circulatory overload (TACO) is a growing concern in clinical practice. STUDY DESIGN AND METHODS: A case control study was performed at the Nîmes University Hospital, France. TACO cases occurring after RBC transfusion reported from January 1, 2014, to May 31, 2017, were included as cases. Four controls by case were randomly selected among the other RBC recipients on the same day. RESULTS: During the study period, 60 TACO diagnoses were reported for 37,029 transfused RBCs to a total of 8787 patients; 240 controls were included. The average rate of TACO was one case every 616 RBCs transfused. One in 146 transfused patients experienced TACO. TACO was associated with a higher 28-day mortality (22% vs. 11%; p = 0.003), and a longer hospital stay compared with controls (23.5 ± 19.6 days vs. 15.9 ± 20.1 days; p < 0.001). Four risk factors were independently associated with TACO in multivariable analysis: chronic use of loop diuretics (odds ratio [OR], 6.5, 95% confidence interval [CI], 3.3-12.9), hemorrhagic shock (OR, 12; 95% CI, 2.9-50), body weight <46 kg (OR, 7.9; 95% CI, 2.3-26.8) and chronic hypertension (OR, 4.1; 95% CI, 2-8.5). CONCLUSION: TACO was frequent and associated with poor outcome. Four independent risk factors were identified: hemorrhagic shock, low body weight, chronic use of diuretics, and chronic hypertension.

Sore throat following three adult supraglottic airway devices: A randomised controlled trial.

BACKGROUND: Sore throat is a common complaint after surgery. It affects patient satisfaction and can affect activity after discharge. The supraglottic airway device (SAD) offers an alternative to traditional tracheal intubation with potential benefit in preventing sore throat. OBJECTIVE: The aim of this study was to compare the incidence of sore throat following three different SADs, the laryngeal mask airway Unique (LMA-U) and the more recent LMA Supreme (LMA-S) and the I-gel. DESIGN: A randomised single-blind controlled three parallel-group trial. SETTING: University Hospital of Nîmes, Division of Anaesthesia Intensive Care Pain and Emergency, Nîmes, France, from April 2009 to September 2012. PATIENTS: A total of 546 patients scheduled to undergo elective surgery of less than 2 h under general anaesthesia were randomly allocated to receive the LMA-U, the LMA-S or the I-gel. INTERVENTIONS: Anaesthesia was induced with propofol and sufentanil and maintained with propofol or with sevoflurane in air-oxygen. After airway device insertion, intra-cuff pressure was adjusted to less than 60 mmHg (LMA-U, LMA-S) and pressure-controlled ventilation initiated. MAIN OUTCOMES: The primary study endpoint was to compare incidence of sore throat 24 h postoperatively (H+24) following placement of the LMA-U, LMA-S and the I-gel. Secondary endpoints were clinical performance (airway leak pressure, dynamic airway compliance, complications during maintenance), ease of use (device insertion time, success on first attempt, ease of insertion and removal) and other adverse events (neck or jaw pain, dysphonia, dysphagia, nausea and vomiting). RESULTS: The authors analysed 177, 174 and 173 patients who received LMA-U, the LMA-S and the I-gel, respectively. The primary endpoint was assessed in 436 patients. In total, 104 patients (23.9%) patients reported a H+24 sore throat, with no difference between groups (P = 0.34). H+24 dysphagia with liquids was higher (P = 0.0065) with the LMA-S (12.1%) compared with LMA-U (5.3%) and I-gel (2.9%). Airway leak pressure (cmH2O) was lower (P < 0.0001) with LMA-U [21 (18 to 27)] compared with I-gel [26 (20 to 30)] and LMA-S [25 (21 to 30)]. Device insertion time (sec) was shorter (P < 0.0167) with the I-gel [30 (20 to 40)] compared with the LMA-U [34 (23 to 48)] and LMA-S [32 (22 to 50)]. CONCLUSION: The incidence of postoperative sore throat was not significantly different between the three SADs studied.

Role of the internet as an information resource before anaesthesia consultation: A French prospective multicentre survey.

BACKGROUND: Use of the internet as an information search tool has increased dramatically. Our study assessed preoperative use of the internet by patients to search for information regarding anaesthesia, surgery, pain or outcomes. OBJECTIVE(S): The aim of this study was to test whether patients used the internet prior to surgery and what kinds of information they looked for (anaesthetic technique, pain, adverse events, outcomes and surgery). Correlation between patient age and information sought about surgery from the internet was also explored. DESIGN: A prospective multicentre observational study. SETTING: In total, 14 French private and public institutions from May 2015 to January 2016. PATIENTS: In total, 3161 adult patients scheduled for elective surgery under regional or general anaesthesia. INTERVENTION(S): An anonymous questionnaire was presented to adult patients scheduled for elective surgery under regional or general anaesthesia for completion before the first meeting with the anaesthesiologist. The investigator at each centre completed specific items that the patient could not complete. MAIN OUTCOME MEASURES: We defined the primary endpoint as the number of patients who searched for information about their anaesthesia or surgery on the internet by the time of the their preanaesthetic consultation. RESULTS: Of the 3234 questionnaires distributed, responses were received from 3161 patients. Within this respondent sample, 1304 (45%) were professionally active and 1664 (59%) used the internet at least once per day. Among 3098 (98%) patients who answered the question concerning the primary endpoint, 1506 (48%) had searched the internet for information about their health. In total, 784 (25%) used the internet to find information about their surgery and 113 (3.5%) looked for specific information about anaesthesia. Of the 3161, 52% reported difficulty searching for appropriate information about anaesthesia on the internet. 'Daily use of the web' [odds ratio (OR) 2.0; (95% CI: 1.65 to 2.55) P < 0.001], 'use of the web on mobile devices' [OR 1.24; (95% CI: 1.02 to 1.50) P = 0.02] and 'asking general practitioner or surgeon about information' [OR 1.35; (95% CI: 1.11 to 1.64) P = 0.002] were significantly associated with the primary endpoint. CONCLUSION: The internet was not widely used by patients scheduled for elective surgery to search for information about anaesthesia and surgery in our French multicentre study. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02442609.

Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial.

Importance: Perioperative hypotension is associated with an increase in postoperative morbidity and mortality, but the appropriate management strategy remains uncertain. Objective: To evaluate whether an individualized blood pressure management strategy tailored to individual patient physiology could reduce postoperative organ dysfunction. Design, Setting, and Participants: The Intraoperative Norepinephrine to Control Arterial Pressure (INPRESS) study was a multicenter, randomized, parallel-group clinical trial conducted in 9 French university and nonuniversity hospitals. Adult patients (n = 298) at increased risk of postoperative complications with a preoperative acute kidney injury risk index of class III or higher (indicating moderate to high risk of postoperative kidney injury) undergoing major surgery lasting 2 hours or longer under general anesthesia were enrolled from December 4, 2012, through August 28, 2016 (last follow-up, September 28, 2016). Interventions: Individualized management strategy aimed at achieving a systolic blood pressure (SBP) within 10% of the reference value (ie, patient's resting SBP) or standard management strategy of treating SBP less than 80 mm Hg or lower than 40% from the reference value during and for 4 hours following surgery. Main Outcomes and Measures: The primary outcome was a composite of systemic inflammatory response syndrome and dysfunction of at least 1 organ system of the renal, respiratory, cardiovascular, coagulation, and neurologic systems by day 7 after surgery. Secondary outcomes included the individual components of the primary outcome, durations of ICU and hospital stay, adverse events, and all-cause mortality at 30 days after surgery. Results: Among 298 patients who were randomized, 292 patients completed the trial (mean [SD] age, 70 [7] years; 44 [15.1%] women) and were included in the modified intention-to-treat analysis. The primary outcome event occurred in 56 of 147 patients (38.1%) assigned to the individualized treatment strategy vs 75 of 145 patients (51.7%) assigned to the standard treatment strategy (relative risk, 0.73; 95% CI, 0.56 to 0.94; P = .02; absolute risk difference, -14%, 95% CI, -25% to -2%). Sixty-eight patients (46.3%) in the individualized treatment group and 92 (63.4%) in the standard treatment group had postoperative organ dysfunction by day 30 (adjusted hazard ratio, 0.66; 95% CI, 0.52 to 0.84; P = .001). There were no significant between-group differences in severe adverse events or 30-day mortality. Conclusions and Relevance: Among patients predominantly undergoing abdominal surgery who were at increased postoperative risk, management targeting an individualized systolic blood pressure, compared with standard management, reduced the risk of postoperative organ dysfunction. Trial Registration: clinicaltrials.gov Identifier: NCT01536470.

Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial.

IMPORTANCE: Sedative premedication is widely administered before surgery, but little clinical evidence supports its use. OBJECTIVE: To assess the efficacy of sedative premedication on perioperative patient experience. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial, the PremedX study, enrolled 1062 adult patients who were younger than 70 years and had been scheduled for various elective surgeries under general anesthesia at 5 French teaching hospitals (in Marseille, Montpellier, Nimes, and Nice) between January 2013 and June 2014. Neurosurgery, obstetrical, cardiac, and outpatient surgery were excluded. INTERVENTIONS: Patients were randomized to 3 groups of 354 participants each to receive 2.5 mg of lorazepam, no premedication, or placebo. MAIN OUTCOMES AND MEASURES: The primary outcome was perioperative patient experience assessed 24 hours after surgery with a validated questionnaire (Evaluation du Vécu de l'Anesthésie Generale; EVAN-G) describing 6 domains of satisfaction and a global index (score range, 0-100; high scores represent high satisfaction); secondary outcomes included time to extubation and early cognitive recovery. A subgroup analysis was planned a priori in patients with a high level of preoperative anxiety. RESULTS: Premedication with lorazepam did not improve the EVAN-G mean global index for overall level of patient satisfaction (72 [95% CI, 70-73]; n = 330) compared with no premedication (73 [95% CI, 71-74]; n = 319) or placebo (71 [95% CI, 70-73]; n = 322) (P = .38). Among patients with heightened preoperative anxiety, there were no significant differences found in the EVAN-G mean global index between the lorazepam group (68 [95% CI, 65-72]; n = 87) and the no premedication group (73 [95% CI, 69-77]; n = 57) or the placebo group (70 [95% CI, 67-72]; n = 87) (P = .18). Time to extubation was 17 minutes (95% CI, 14-20 minutes) in the lorazepam group, 12 minutes (95% CI, 11-13 minutes) for the no premedication group, and 13 minutes (95% CI, 12-14 minutes) for the placebo group (P < .001) and the rate of early cognitive recovery was 51% (95% CI, 45%-56%), 71% (95% CI, 66%-76%), and 64% (95% CI, 59%-69%), respectively (P < .001). CONCLUSIONS AND RELEVANCE: Among patients undergoing elective surgery under general anesthesia, sedative premedication with lorazepam compared with placebo or no premedication did not improve the self-reported patient experience the day after surgery, but was associated with modestly prolonged time to extubation and a lower rate of early cognitive recovery. The findings suggest a lack of benefit with routine use of lorazepam as sedative premedication in patients undergoing general anesthesia. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01901003.

Teleconsultation compared with face-to-face consultation in the context of pre-anesthesia evaluation: TELANESTH, a randomized controlled single-blind non-inferiority study.

STUDY OBJECTIVE: During the COVID crisis, pre-anesthesia teleconsultations were widely used leading to savings in time and money. However, the non-inferiority of this system has not yet been evaluated. DESIGN: Prospective, randomized, controlled, single-blind non-inferiority study. SETTING: University hospital. PATIENTS: Patients scheduled for surgery requiring a single pre-anesthesia consultation (PAC). INTERVENTION: Pre-anesthesia teleconsultation (PATC) from patient's home. MEASUREMENTS: Primary outcome: concordance between the pre-anesthesia visit (PAV), performed on the day of surgery, and PAC or PATC on: Secondary outcomes: cancellation rate, immediate perioperative complications, patient satisfaction, organization, and economic and ecological costs. MAIN RESULTS: Out of 172 patients included, 149 were analyzed. PATC was no less effective than PAC in terms of the primary outcome or each of its components: the difference between groups was: - 0.044[90% CI: -0.135; 0.047] (p = 0.0002). There was no difference in cancellation rates (PAC 1.99% vs. PATC 1.27%, p = 0.6) or in immediate perioperative complications (none). Satisfaction was 9.48 (±1.45) in the PAC group and 8.96 (±1.68) in the PATC group (p = 0.0006). In the PATC group, the mean savings per patient were 30 km (± 29), 36 min (± 27), and 18 (± 18) euros, respectively. CONCLUSIONS: According to our criteria, PATC was not inferior to PAC for preoperative patient evaluation and may be an interesting economical, ecological alternative.

Association of the immediate perioperative dynamics of circulating DNA levels and neutrophil extracellular traps formation in cancer patients.

Objectives: Elevated circulating DNA (cirDNA) concentrations were found to be associated with trauma or tissue damage which suggests involvement of inflammation or cell death in post-operative cirDNA release. We carried out the first prospective, multicenter study of the dynamics of cirDNA and neutrophil extracellular trap (NETs) markers during the perioperative period from 24 h before surgery up to 72 h after curative surgery in cancer patients. Methods: We examined the plasma levels of two NETs protein markers [myeloperoxidase (MPO) and neutrophil elastase (NE)], as well as levels of cirDNA of nuclear (cir-nDNA) and mitochondrial (cir-mtDNA) origin in 29 colon, prostate, and breast cancer patients and in 114 healthy individuals (HI). Results: The synergistic analytical information provided by these markers revealed that: (i) NETs formation contributes to post-surgery conditions; (ii) post-surgery cir-nDNA levels were highly associated with NE and MPO in colon cancer [r = 0.60 (P < 0.001) and r = 0.53 (P < 0.01), respectively], but not in prostate and breast cancer; (iii) each tumor type shows a specific pattern of cir-nDNA and NETs marker dynamics, but overall the pre- and post-surgery median values of cir-nDNA, NE, and MPO were significantly higher in cancer patients than in HI. Conclusion: Taken as a whole, our work reveals the association of NETs formation with the elevated cir-nDNA release during a cancer patient's perioperative period, depending on surgical procedure or cancer type. By contrast, cir-mtDNA is poorly associated with NETs formation in the studied perioperative period, which would appear to indicate a different mechanism of release or suggest mitochondrial dysfunction.

Preoperative ketamine administration for prevention of postoperative neurocognitive disorders after major orthopedic surgery in elderly patients: A multicenter randomized blinded placebo-controlled trial.

BACKGROUND: Preventive anesthetic impact on the high rates of postoperative neurocognitive disorders in elderly patients is debated. The Prevention of postOperative Cognitive dysfunction by Ketamine (POCK) study aimed to assess the effect of ketamine on this condition. METHODS: This is a multicenter, randomized, double-blind, interventional study. Patients ≥60 years undergoing major orthopedic surgery were randomly assigned in a 1:1 ratio to receive preoperative ketamine 0.5 mg/kg as an intravenous bolus (n = 152) or placebo (n = 149) in random blocks stratified according to the study site, preoperative cognitive status and age. The primary outcome was the proportion of objective delayed neurocognitive recovery (dNR) defined as a decline of one or more neuropsychological assessment standard deviations on postoperative day 7. Secondary outcomes included a three-month incidence of objective postoperative neurocognitive disorder (POND), as well as delirium, anxiety, and symptoms of depression seven days and three months after surgery. RESULTS: Among 301 patients included, 292 (97%) completed the trial. Objective dNR occurred in 50 (38.8%) patients in the ketamine group and 54 (40.9%) patients in the placebo group (OR [95% CI] 0.92 [0.56; 1.51], p = 0.73) on postoperative day 7. Incidence of objective POND three months after surgery did not differ significantly between the two groups nor did incidence of delirium, anxiety, apathy, and fatigue. Symptoms of depression were less frequent in the ketamine group three months after surgery (OR [95% CI] 0.34 [0.13-0.86]). CONCLUSIONS: A single preoperative bolus of intravenous ketamine does not prevent the occurrence of dNR or POND in elderly patients scheduled for major orthopedic surgery. (Clinicaltrials.gov NCT02892916).

Blood wastage reduction: a 10-year observational evaluation in a large teaching institution in France.

CONTEXT: Blood transfusion has increased significantly during the last decade and blood wastage reduction is a medical and economic challenge in hospital practice and for institutional quality, particularly in the ICU and operating theatre. OBJECTIVE: To evaluate the impact of multiple strategies in one hospital to reduce red blood cell wastage. DESIGN: Multicentre, prospective, comparative, observational study. SETTING: Over 10 years, the study was conducted over two time periods. During the first period (2000 to 2003), information was given to medical professionals about blood wastage, and audits (reasons for wastage) were performed, in a large teaching institution (more than 4% wastage in 1999). The second period (2004 to 2010) was designed to analyse the impact of seven strategies intended to minimise blood wastage. Blood wastage reduction in the local centre was compared with regional (64 institutions) and national centres (1470 institutions). Reduction was compared using the Mann-Kendall non-parametric trend test. PATIENTS: Local centre (22,572 transfused patients, Nîmes, France), regional centre (South France, 64 institutions, 208,525 transfused patients) and national centres (France, 1470 institutions). INTERVENTIONS: Medical and surgical procedures. MAIN OUTCOME MEASURES: The primary end-point was to describe the percentage of blood wastage for two periods in a local centre. The secondary objective was to compare the percentage of blood wastage in the local centre with wastage at regional and national centres. RESULTS: Over the 10 year study period the percentage of blood wastage in the local centre decreased, with a significant reduction in the second period, from more than 4% (1999) to less than 1% (2010; P < 0.05). Blood wastage at regional and national centres was never less than 1%. Inadequate containers for transport, absence of a temperature analyser in the ICU and inadequate intraoperative blood strategies (excessive orders of blood) were the main causes of wastage. Correction of these points affected the outcome favourably in the second period, but transfusion information was poor in the first period. CONCLUSION: Seven simple strategies (including transport containers with an effective temperature analyser and audits) decreased blood wastage, especially in the ICU and operating theatre.