The latest medical research on Anesthesiology
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Assessments of Onset and Duration of Drug Effects and Pharmacokinetics by Dose Level of HSK3486, a New Sedative-Hypnotic Agent, in Healthy Female/Male Subjects: A Phase I Multiarm Randomized Controlled Clinical Trial.Anesthesia and Analgesia
Onset and duration of effects and pharmacokinetics of the novel anesthesia medication HSK3486 were examined after a single intravenous injection to evaluate its usefulness as a potential alternative to propofol.
Phase Ia (male-only, blinded) and Ib (female-only, open-label) trials were both prospective randomized, dose escalation trials of a single intravenous injection of HSK3486 or either placebo or propofol. The primary aim of this first-in-human trial was safety through measurements of dose-related effects on cardiorespiratory functions, the central nervous system, laboratory parameters, and reported adverse events. The secondary aims were to determine initial pharmacokinetic parameters and to establish a dose regimen for sedation and general anesthesia for subsequent later-phase clinical trials.
A total of 50 healthy male subjects were enrolled in the phase Ia trial and 30 healthy female subjects in the phase Ib trial. No significant difference was found in the overall pattern of anesthetic effects between HSK3486 and propofol (all P > .05), but the sample size was not sufficiently large to make a confident assessment. Rapid onset and offset of dose-dependent sedation or general anesthesia after HSK3486 administration was found in male and female subjects with median central nervous system equilibrium half-life times of 1.3 and 1.8 minutes across cohorts in phases Ia and Ib and accompanied by mild hypotension and respiratory depression. Pharmacokinetics profiles revealed that there was no evidence that the groups were different (all P > .05), with a high clearance and distribution volume. In the phase Ia trial, the median terminal half-life (t1/2) for HSK3486 doses of 128, 192, 288, 432, 540, 648, and 810 μg/kg were 68.8, 64.7, 207.0, 210.7, 313.5, 293.5, and 245.7 minutes, respectively. In the phase Ib trial, the median t1/2 for HSK3486 doses of 288, 432, 540, 648, and 810 μg/kg were 68.5, 159.7, 122.7, 281.5, and 245.3 minutes, respectively. Treatment emergent adverse events (TEAEs) were reported in 50% and 53% of subjects in the phase Ia and Ib trials but were mostly related to minor events (eg, arterial catheter irritation). HSK3486 was well tolerated at dose levels up to 810 μg/kg in all subjects compared with propofol (odds ratio in phases Ia and Ib: 0.71 and 6.00; 95% confidence interval [CI], 0.09-4.85 and 0.47-314.71, respectively; all P > .05) and placebo (odds ratio in phase Ia: 0.95; 95% CI, 0.01-78.45; P > .05).
HSK3486 has potential clinical application for intravenous administration for the induction and maintenance of sedation and general anesthesia.
Developing a Clinical Prediction Score: Comparing Prediction Accuracy of Integer Scores to Statistical Regression Models.Anesthesia and Analgesia
Researchers often convert prediction tools built on statistical regression models into integer scores and risk classification systems in the name o...
Comparison of the Analgesic Duration of 0.5% Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivacaine Versus 1% Ropivacaine for Low-Volume Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Trial.Anesthesia and Analgesia
Bupivacaine and ropivacaine are the preferred long-acting local anesthetics for peripheral nerve blocks as they provide prolonged analgesia in the postoperative period. No studies have directly compared the analgesic duration of these commonly used local anesthetics in the setting of low-volume ultrasound-guided interscalene block (US-ISB). This study was designed to determine which local anesthetic and concentration provides superior analgesia (duration and quality) for low-volume US-ISB.
Sixty eligible patients scheduled for arthroscopic shoulder surgery were randomized (1:1:1) to receive US-ISB (5 mL) with 0.5% bupivacaine with 1:200,000 epinephrine, 0.5% ropivacaine, or 1% ropivacaine. All individuals were blinded including study participants, anesthesiologists, surgeons, research personnel, and statistician. All participants received a standardized general anesthetic and multimodal analgesia. The primary outcome was duration of analgesia defined as the time from the end of injection to the time that the patients reported a significant increase in pain (>3 numeric rating scale [NRS]) at the surgical site.
The mean duration of analgesia for 0.5% bupivacaine with 1:200,000 epinephrine, 0.5% ropivacaine, or 1% ropivacaine was 14.1 ± 7.4, 13.8 ± 4.5, and 15.8 ± 6.3 hours, respectively (analysis of variance [ANOVA], P = .51). There were no observed differences in analgesic duration or other secondary outcomes between the 3 groups with the exception of a difference in cumulative opioid consumption up to 20h00 on the day of surgery in favor of ropivacaine 0.5% over bupivacaine of minimal clinical significance.
In the context of single-injection low-volume US-ISB, we have demonstrated a similar efficacy between equal concentrations of ropivacaine and bupivacaine. In addition, increasing the concentration of ropivacaine from 0.5% to 1% did not prolong the duration of US-ISB.
Using psychometric ability to improve education in ultrasound-guided regional anaesthesia: a multicentre randomised controlled trial.Anaesthesia
The learning curve for novices developing regional anaesthesia skills, such as real-time ultrasound-guided needle manipulation, may be affected by ...
Patient and Procedural Determinants of Postoperative Pain Trajectories.Anesthesiology
The primary goal of this study was to evaluate patterns in acute postoperative pain in a mixed surgical patient cohort with the hypothesis that there would be heterogeneity in these patterns.
This study included 360 patients from a mixed surgical cohort whose pain was measured across postoperative days 1 through 7. Pain was characterized using the Brief Pain Inventory. Primary analysis used group-based trajectory modeling to estimate trajectories/patterns of postoperative pain. Secondary analysis examined associations between sociodemographic, clinical, and behavioral patient factors and pain trajectories.
Five distinct postoperative pain trajectories were identified. Many patients (167 of 360, 46%) were in the moderate-to-high pain group, followed by the moderate-to-low (88 of 360, 24%), high (58 of 360, 17%), low (25 of 360, 7%), and decreasing (21 of 360, 6%) pain groups. Lower age (odds ratio, 0.94; 95% CI, 0.91 to 0.99), female sex (odds ratio, 6.5; 95% CI, 1.49 to 15.6), higher anxiety (odds ratio, 1.08; 95% CI, 1.01 to 1.14), and more pain behaviors (odds ratio, 1.10; 95% CI, 1.02 to 1.18) were related to increased likelihood of being in the high pain trajectory in multivariable analysis. Preoperative and intraoperative opioids were not associated with postoperative pain trajectories. Pain trajectory group was, however, associated with postoperative opioid use (P < 0.001), with the high pain group (249.5 oral morphine milligram equivalents) requiring four times more opioids than the low pain group (60.0 oral morphine milligram equivalents).
There are multiple distinct acute postoperative pain intensity trajectories, with 63% of patients reporting stable and sustained high or moderate-to-high pain over the first 7 days after surgery. These postoperative pain trajectories were predominantly defined by patient factors and not surgical factors.
Cardiovascular events in patients undergoing hip fracture surgery treated with remote ischaemic preconditioning: 1-year follow-up of a randomised clinical trial.Anaesthesia
Remote ischaemic preconditioning reduces the risk of myocardial injury within 4 days of hip fracture surgery. We aimed to investigate the effect of...
Volatile anaesthesia and peri-operative outcomes related to cancer: a feasibility and pilot study for a large randomised control trial.Anaesthesia
Published data suggest that the type of general anaesthesia used during surgical resection for cancer may impact on patient long-term outcome. Howe...
The Anaesthesia Case Report (ACRE) checklist: a tool to promote high-quality reporting of cases in peri-operative practice.Anaesthesia
Case reports have fulfilled an important role in the development of anaesthesia and continue to be highly relevant to modern practice. Despite this...
Hyperbaric prilocaine vs. hyperbaric bupivacaine for spinal anaesthesia in women undergoing elective caesarean section: a comparative randomised double-blind study.Anaesthesia
Hyperbaric bupivacaine spinal anaesthesia remains the gold standard for elective caesarean section, but the resultant clinical effects can be unpre...
Comparing catheter related bloodstream infection rate between cuffed tunnelled and non-cuffed tunnelled peripherally inserted central catheter.J Vasc Access
To compare catheter related blood stream infection (CRBSI) rate between cuffed tunnelled and non-cuffed tunnelled PICC.
We prospectively followed 100 patients (50:50 cuffed and non-cuffed PICC) and compared CRBSI rate between these groups. Daily review and similar catheter care were performed until a PICC-related complication, completion of therapy, death or defined end-of-study date necessitate removal. CRBSI was confirmed in each case by demonstrating concordance between isolates colonizing the PICC at the time of infection and from peripheral blood cultures.
A total of 50 cuffed PICC were placed for 1864 catheter-days. Of these, 12 patients (24%) developed infection, for which 5 patients (10%) had a CRBSI for a rate of 2.7 per 1000 catheter-days. Another 50 tunnelled non-cuffed PICCs were placed for 2057 catheter-days. Of these, 7 patients (14%) developed infection, for which 3 patients (6%) had a CRBSI. for a rate of 1.5 per 1000 catheter-days. The mean time to development of infection is 24 days in cuffed and 19 days in non-cuffed groups. The mean duration of utilization was significantly longer in non-cuffed than in cuffed group (43 days in non-cuffed vs 37 days in cuffed group, p = 0.008).
Cuffed PICC does not further reduce the rate of local or bloodstream infection. Tunnelled non-cuffed PICC is shown to be as effective if not better at reducing risk of CRBSI and providing longer catheter dwell time compared to cuffed PICC.
Retained port connectors after central venous port removal.J Vasc Access
We report three cases where the connector/sleeve, which helps fix the flexible catheter section to a port injection chamber, was inadvertently left...
Arterial diameter following arteriovenous fistula creation predicts aneurysm progression.J Vasc Access
To investigate the relationship between arteriovenous fistula (AVF) arterial diameter (AD) and AVF aneurysm development and progression.
This study identified all patients who underwent fistulograms which demonstrated AVF aneurysms meeting criteria and requiring surgical intervention between 01/01/2014 and 7/30/2016. Patient demographics were collected and AVF dimensions were measured on fistulograms. A control group with nonaneurysmal AVFs who had undergone serial fistulograms between 2013 and 2016 were identified and identical datasets collected. Statistical analysis was performed with STATA 14.0 using student's t-test, Chi square tests and linear regression.
45 eligible patients were identified in the AVF aneurysm study group and 24 in the control group, with the mean age of AVF creation being older in the control group (61.8 vs 53 years, p = 0.03). The mean interval between AVF creation and first fistulogram in the study group was 1464 ± 282 days, compared to an interval of 263 ± 101 days in the control group (p = 0.003). The AD on the first fistulogram in those study group patients with aneurysms evident on first fistulogram was greater than in the control group (6.5±1.8 mm vs 5.0 ± 1.8 mm, p = 0.003). The AD on first fistulogram of the study group predicted maximum aneurysm diameter on last fistulogram (r = 0.6, p = 0.03) as well as the interval between first fistulogram and surgical revision (r = -0.33, p = 0.03).
AVF aneurysms are a later complication in access natural history and AD may help to predict their progression.