Journal of Clinical Anesthesia最新文献

Study objective: VVZ-149 is a small molecule that inhibits the glycine transporter type 2 and the serotonin receptor 5-hydroxytryptamine 2 A. In this Phase 3 study, we investigated the efficacy and safety of VVZ-149 as a single-use injectable analgesic for treating moderate to severe postoperative pain after laparoscopic colectomy.

Design: Randomized, parallel group, double-blind, Phase 3 clinical trial (Trial no. NCT05764525).

Setting: 5 tertiary referral centers in South Korea.

Patients: 284 patients undergoing laparoscopic colectomy.

Interventions: A continuous 10-h intravenous infusion of VVZ-149 (n = 141) or placebo (n = 143) administered after emergence from anesthesia.

Measurements: Pain intensity was assessed using a numeric rating scale (NRS) from the start of infusion for 48 h. The primary efficacy measure was the Sum of Pain Intensity Difference (SPID) for the first 12 h after the start of drug infusion. Other efficacy measures included SPID at other time points, opioid consumption via on-demand patient-controlled analgesia (PCA) and rescue medication, and proportion of patients who did not require rescue opioids for 48 h post-dose.

Main results: Pain relief as measured by SPID was significantly improved by 35 % in the VVZ-149 group compared to the placebo group at 6 h (p = 0.0193) and 12 h (p = 0.0047) after the start of infusion. Significantly lower pain intensity scores were observed between 4-10 h in the VVZ-149 group compared to the placebo group (p = 0.0007), reaching mild pain (mean NRS <4) at 8 h. VVZ-149 alleviated pain during the first 12 h post-dose with 30.8 % less opioid consumption and 60.2 % fewer PCA requests when compared with placebo. A higher proportion of patients receiving VVZ-149 were rescue opioid-free during 2-6 h (p = 0.0026) and 6-12 h (p = 0.0024) compared with the placebo group. VVZ-149 administration in post-colectomy patients was generally safe and well tolerated.

Conclusions: When compared to placebo, VVZ-149 infusion demonstrated a significant reduction of pain within the first 12 h after surgery with a substantial decrease in opioid use. VVZ-149 rapidly lowers the pain intensity starting at as early as 4 h post-dose, allowing subjects to experience mild pain levels from 8 h through 48 h. Therefore, the analgesic effect of VVZ-149 was shown to effectively relieve pain and reduce opioid use for treating moderate to severe pain in the early postoperative care setting.

Registration number: Trial Number NCT05764525.

Postoperative acute kidney injury (AKI) is common after non-cardiac surgery. Normal saline and lactated Ringer's solution are both used for volume replacement during surgery. Normal saline decreases renal blood flow and causes hyperchloremic acidosis whereas lactated Ringer's does not. The incidence of AKI is similar with modest volumes of each fluid. But it remains unclear whether larger volumes of normal saline provoke AKI.

Objective: Evaluate whether intraoperative crystalloid volume modifies the relationship between the AKI risk and treatment group.

Design: Secondary analysis of a single-center multiple cross-over cluster trial.

Setting: Intraoperative care.

Patients: We enrolled 8616 adults who had colorectal or orthopedic surgery at a large academic institution.

Interventions: Clusters of patients were alternately assigned to intraoperative normal saline or lactated Ringer's solution.

Measurements: The primary outcome was the incidence of acute kidney injury (AKI) as a function of intraoperative crystalloid volume (0-1, 1-2, 3-4, or 4+ liters) and the type of crystalloid. Our secondary outcome was the change in postoperative serum chloride concentration during the first 24 h.

Main results: The risk of AKI did not differ significantly in patients given 0-1, 1-2, or 3-4 L saline or lactated Ringers solutions. In contrast, patients given 2-3 or > 4 L of lactated Ringer's solution had a higher risk of AKI than those given saline. Patients assigned to normal saline had progressively greater plasma chloride concentrations than those given lactated Ringer's across all volume categories.

Conclusions: While saline administration clearly causes volume-dependent hyperchloremia, we found no evidence to support the theory that large volumes of saline provoke AKI. Therefore, either fluid seems reasonable for intraoperative use.

Background: This study evaluated the spread of a local anesthetic, using MRI and sensory blockade, after an intertransverse process block (ITPB) at the medial aspect of the retro-superior costotransverse ligament (retro-SCTL) space - the medial retro-SCTL space block.

Methods: Ten healthy volunteers received a single-injection ultrasound-guided medial retro-SCTL space block at the T4-T5 level using a mixture of 10 ml 0.5 % bupivacaine with 0.5 ml gadolinium. At 15 min, they underwent a high resolution, fat suppressed, T1 weighted MRI scan of the cervicothoracic spine. Loss of sensation to cold was assessed at 15 and 60 min, and then hourly for 5-h, after the block.

Results: MRI showed consistent (100 %) spread of local anesthetic to the intercostal and paravertebral spaces, anterolateral aspect of the vertebral body (sympathetic chain), costotransverse space, neural foramina, and epidural space in all participants. However, sensory blockade was variable across the ipsilateral hemithorax. Hypoesthesia was more common than anesthesia in both the anterior (median [IQR], 3.5 [2-5] vs 0 [0-1.25], p < 0.001) and posterior (median [IQR], 6[3-7] vs 2[1-3], p < 0.001) hemithorax. Additionally, more dermatomes exhibited anesthesia in the posterior compared to the anterior hemithorax (median [IQR], 2[1-3] vs 0[0-1.25], p = 0.01). A variable number of contralateral dermatomes were also affected in 3 (30 %) volunteers. There was no statistically significant correlation between the local anesthetic spread and the number of hypoesthetic (r = 0.53, p = 0.11) or anesthetic (r = 0.09, p = 0.78) dermatomes on the ipsilateral hemithorax.

Conclusions: A single-injection medial retro-SCTL space block, at the T4-T5 level with 10.5 ml of local anesthetic, consistently spreads to the ipsilateral intercostal and paravertebral spaces, sympathetic chain, costotransverse space, neural foramina and epidural space, but produces ipsilateral sensory blockade that is variable and wider over the posterior than anterior hemithorax.

Background: Accurate blood pressure monitoring is essential in many clinical scenarios for adults and children and, when continuous measurement is critical, necessitates the insertion of an arterial line. A novel continuous non-invasive arterial pressure monitoring device using a pulse contour algorithm (Pulse Decomposition Analysis), Vitalstream™, is approved by the United States Food and Drug Administration for use in adults. In this study the performance and accuracy of the device compared to intraarterial blood pressure monitoring were assessed in children ages 2-17 undergoing major surgeries. We report the results using comparison to aspects of the recently published ISO 81060-3:2022 standard for continuous automated blood pressure measurement.

Methods: 31 children ages 2-17 years scheduled for major surgery requiring invasive arterial blood pressure monitoring were consented to participate. Systolic, diastolic, and mean arterial blood pressure readings were obtained from both systems during at least thirty minutes of simultaneous monitoring during hemodynamically stable periods of the surgical procedure and statistically compared.

Results: The correlations of systolic and, diastolic, and mean arterial pressures were, respectively, 0.77, 0.68 and 0.7. The Bland-Altman comparisons yielded bias of -3.79 (9.74) mmHg, 1.72 (8.45) mmHg and 2.41 (8.75) mmHg respectively, for systolic, diastolic, and mean arterial pressures, (p < 0.001 for all comparisons). Concordances for systole, diastole and MAP were, respectively, 0.82, 0.85 and 0.83.

Conclusions: Most values fell within +/-20mmhg of the corresponding arterial line values. While this meets the basic requirement for such devices published by professional societies, clinicians will need to be aware of the potential variances and make clinical decisions accordingly. The Vitalstream™ may offer low risk, accurate continuous pressure monitoring in children ages 2-17.

Clinical trials: gov: NCT04817137 The trial was registered at clinicaltrials.gov (NCT048I7173).

Background: Blood loss resulting in severe anemia is the most common indication for postoperative allogenic red blood cell (RBC) transfusions. In high-income countries, the majority of transfusions is received by elderly patients. Preservatives extend the storage of RBCs, though concerns exist about potential harm from transfusing older RBCs. This study tested the hypothesis that RBC storage duration effects hemoglobin increase in patients older than 70 years who underwent non-cardiac surgery.

Method: Observations on surgical cohorts from two study sites of the LIBERAL-Trial were collected. Transfusion events and hemoglobin between 2018 and 2022 assessments in addition to manufacturing and product specific quality review information were evaluated.

Results: A total of 1626 transfusion events in 505 patients were analyzed. A linear mixed effects model was used to estimate the effect size of different predictors on hemoglobin increment upon red blood cell transfusion. No statistically significant effect of the RBC unit storage duration was found. Confounding variables resulting in higher hemoglobin increase included lower hemoglobin values prior to transfusion, the length of Hb measurement intervals before and after transfusion, as well as the method of RBC cell separation in line with different manufacturer hemoglobin values.

Conclusions: The aspired increase in hemoglobin can be achieved with red blood cell concentrates of any storage duration. In general, elderly patients exhibit a sufficient hemoglobin rise following transfusion. However, if this is associated with improved outcomes cannot be answered.

Objective: To explore risk factors for 1-year postoperative mortality and to identify its association with the Revised Cardiac Risk Index (RCRI).

Methods: This was a retrospective cohort study involving 54,933 patients aged 18 years and above who were surgically treated under general or regional anesthesia in a tertiary hospital in Singapore. Independent risk factors for 1-year postoperative mortality were identified by univariate Cox regression analysis. The association between the RCRI and 1-year postoperative mortality was assessed by the Kaplan-Meier estimator and multivariate Cox regression analysis and was further validated in subgroup analyses stratified by the sex, age, and type of anesthesia.

Results: A total of 54,933 eligible patients were enrolled in this study that included 23,922 patients classified as RCRI Class I, 25,979 as Class II, 3700 as Class III, and 1332 as Class IV. Cox regression analysis demonstrated that male sex, age, higher American Society of Anesthesiologists (ASA) physical status classification level, regional anesthesia, emergency surgery, degree of anemia, and increased RCRI were significantly associated with the increased risk of 1-year postoperative mortality (HR > 1, all P < 0.001). The significant association between RCRI and 1-year postoperative mortality still existed after adjusting for confounding factors. An RCRI Class IV was associated with a mortality risk greater than two-fold larger than that observed at an RCRI Class I (adjusted HR 2.14, 95 % CI 1.78 to 2.56, p < 0.001). Subgroup analyses revealed that the 1-year postoperative mortality was significantly higher in patients with RCRI Class IV than that of Classes I-III regardless of the sex, age, and type of anesthesia.

Conclusion: RCRI is significantly correlated with 1-year postoperative mortality regardless of sex, age, and type of anesthesia. Further studies to validate these findings are warranted.