The intraoperative glycemic response to intravenous insulin during noncardiac surgery: a subanalysis of the DeLiT randomized trial.
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ABSTRACT:
SUBMITTER: Abdelmalak BB
PROVIDER: S-EPMC4762183 | biostudies-literature | 2016 Mar
REPOSITORIES: biostudies-literature
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The intraoperative glycemic response to intravenous insulin during noncardiac surgery: a subanalysis of the DeLiT randomized trial.
Abdelmalak Basem B BB Duncan Andra E AE Bonilla Angela A Yang Dongsheng D Parra-Sanchez Ivan I Fergany Amr A Irefin Samuel A SA Sessler Daniel I DI
Journal of clinical anesthesia 20160202
Patient characteristics may affect patients' response to insulin. We examined the impact of body weight and presence of diabetes on the response to insulin during noncardiac surgery. We studied 202 patients who were enrolled in the DeLiT Trial and received intraoperative intravenous insulin. Univariable and multivariable analyses (Bonferroni corrected) assessed the relationship between patient's response to the initial intraoperative I.V. bolus of regular insulin and the factors of interest. Blo ...[more]
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Project description:BackgroundRecent limited evidence suggests that the use of a processed electroencephalographic (EEG) monitor to guide anesthetic management may influence postoperative cognitive outcomes; however, the mechanism is unclear.MethodsThis exploratory, single-center, randomized clinical trial included patients who were ≥65 years of age undergoing elective noncardiac surgery. The study aimed to determine whether monitoring the brain using a processed EEG monitor reduced EEG suppression and subsequent postoperative delirium. The interventional group received processed EEG-guided anesthetic management to keep the Patient State Index (PSI) above 35 computed by the SEDline Brain Function Monitor (Masimo, Inc, Irvine, CA), while the standard care group was also monitored, but the EEG data were blinded from the clinicians. The primary outcome was intraoperative EEG suppression. A secondary outcome was incident postoperative delirium during the first 3 days after surgery.ResultsAll outcomes were analyzed using the intention-to-treat paradigm. Two hundred and four patients with a mean age of 72 ± 5 years were studied. Minutes of EEG suppression adjusted by the length of surgery was found to be less for the interventional group than the standard care group (median [interquartile range], 1.4% [5.0%] and 2.5% [10.4%]; Hodges-Lehmann estimated median difference [95% confidence interval {CI}] of -0.8% [-2.1 to -0.000009]). The effect of the intervention on EEG suppression differed for those with and without preoperative cognitive impairment (interaction P = .01), with the estimated incidence rate ratio (95% CI) of 0.39 (0.33-0.44) for those with preoperative cognitive impairment and 0.48 (0.44-0.51) for those without preoperative cognitive impairment. The incidence of delirium was not found to be different between the interventional (17%) and the standard care groups (20%), risk ratio = 0.85 (95% CI, 0.47-1.5).ConclusionsThe use of processed EEG to maintain the PSI >35 was associated with less time spent in intraoperative EEG suppression. Preoperative cognitive impairment was associated with a greater percent of surgical time spent in EEG suppression. A larger prospective cohort study to include more cognitively vulnerable patients is necessary to show whether an intervention to reduce EEG suppression is efficacious in reducing postoperative delirium.
| S-EPMC7599075 | biostudies-literature
Project description:Oxygen demand-supply mismatch is supposed to be one of the major causes of myocardial injuries after noncardiac surgery (MINS). Impaired tissue oxygenation during the surgery can lead to intraoperative hyperlactatemia. Therefore, we aimed to evaluate the relationship between intraoperative lactate level and MINS. A total of 1905 patients divided into groups according to intraoperative hyperlactatemia: 1444 patients (75.8%) into normal (≤2.2 mmol/L) and 461 patients (24.2%) into hyperlactatemia (>2.2 mmol/L) groups. The primary outcome was the incidence of MINS, and all-cause mortality within 30 days was compared. In the crude population, the risks for MINS and 30-day mortality were higher for the hyperlactatemia group than the normal group (17.7% vs. 37.7%, odds ratio [OR]: 2.83, 95% confidence interval [CI]: 2.24-3.56, p < 0.001 and 0.8% vs. 4.8%, hazard ratio [HR]: 5.86, 95% CI: 2.9-12.84, p < 0.001, respectively). In 365 propensity score-matched pairs, intraoperative hyperlactatemia was consistently associated with MINS and 30-day mortality (21.6% vs. 31.8%, OR: 1.69, 95% CI: 1.21-1.36, p = 0.002 and 1.1% vs. 3.8%, HR: 3.55, 95% CI: 1.71-10.79, p < 0.03, respectively). Intraoperative lactate elevation was associated with a higher incidence of MINS and 30-day mortality.
| S-EPMC8465750 | biostudies-literature
Project description:BackgroundIntraoperative hypotension (IOH) occurs frequently during surgery and may be associated with organ ischemia; however, few multicenter studies report data regarding its associations with adverse postoperative outcomes across varying hemodynamic thresholds. Additionally, no study has evaluated the association between IOH exposure and adverse outcomes among patients by various age groups.MethodsA multicenter retrospective cohort study was conducted between 2008 and 2017 using intraoperative blood pressure data from the US electronic health records database to examine postoperative outcomes. IOH was assessed in 368,222 noncardiac surgical procedures using 5 methods: (a) absolute maximum decrease in mean arterial pressure (MAP) during surgery, (b) time under each absolute threshold, (c) total area under each threshold, (d) time-weighted average MAP under each threshold, and (e) cumulative time under the prespecified relative MAP thresholds. MAP thresholds were defined by absolute limits (≤75, ≤65, ≤55 mm Hg) and by relative limits (20% and 40% lower than baseline). The primary outcome was major adverse cardiac or cerebrovascular events; secondary outcomes were all-cause 30- and 90-day mortality, 30-day acute myocardial injury, and 30-day acute ischemic stroke. Residual confounding was minimized by controlling for observable patient and surgical factors. In addition, we stratified patients into age subgroups (18-40, 41-50, 51-60, 61-70, 71-80, >80) to investigate how the association between hypotension and the likelihood of major adverse cardiac or cerebrovascular events and acute kidney injury differs in these age subgroups.ResultsIOH was common with at least 1 reading of MAP ≤75 mm Hg occurring in 39.5% (145,743) of cases; ≤65 mm Hg in 19.3% (70,938) of cases, and ≤55 mm Hg in 7.5% (27,473) of cases. IOH was significantly associated with the primary outcome for all age groups. For an absolute maximum decrease, the estimated odds of a major adverse cardiac or cerebrovascular events in the 30-day postsurgery was increased by 12% (95% confidence interval [CI], 11-14) for ≤75 mm Hg; 17.0% (95% CI, 15-19) for ≤65 mm Hg; and by 26.0% (95% CI, 22-29) for ≤55 mm Hg.ConclusionsIOH during noncardiac surgery is common and associated with increased 30-day major adverse cardiac or cerebrovascular events. This observation is magnified with increasing hypotension severity. The potentially avoidable nature of the hazard, and the extent of the exposed population, makes hypotension in the operating room a serious public health issue that should not be ignored for any age group.
| S-EPMC8115733 | biostudies-literature
Project description:BackgroundTotal intravenous anesthesia (TIVA) has been proposed as a method to reduce blood loss during endoscopic sinus surgery (ESS). Impaired sinonasal visualization due to mucosal bleeding may be burdensome in cases of chronic rhinosinusitis (CRS) with high-grade inflammatory disease, suggesting a role for TIVA in that disease subgroup.MethodsA double-blind, randomized controlled trial was conducted of adults undergoing ESS at a tertiary medical center. Patients considered for inclusion had high-grade CRS defined as either sinonasal polyposis or a preoperative Lund-Mackay score of ≥12. Subjects were randomized to receive either TIVA or inhaled anesthesia (IA) during ESS. The primary outcome measure was intraoperative visibility as rated by 3 blinded reviewers utilizing the 10-point Wormald Surgical Field Grading Scale. Secondary outcomes included operative blood loss, complications, and change in quality of life evaluated by the 22-item Sino-Nasal Outcome Test (SNOT-22).ResultsA total of 72 patients were randomized into TIVA (n = 37) and IA (n = 35) study arms. Aggregate median (interquartile range) Wormald scores across all reviewers demonstrated a more favorable visual field with TIVA compared to IA (3.5 [2.4-3.9] vs IA 4.1[3.0-5.8], p = 0.0089). There was significantly less blood loss in the TIVA group compared to the IA group (200 mL [100-450] vs 300 mL [200-500], p = 0.046). Baseline patient characteristics were comparable between cohorts with no significant postoperative complications. No significant changes were detected between postoperative SNOT-22 scores at 3 months (p = 0.278) and at 6 months (p = 0.396) following ESS.ConclusionTIVA contributes to improved intraoperative visualization and decreased blood loss in patients undergoing ESS for high-grade inflammatory sinus disease.
| S-EPMC6433621 | biostudies-literature
Project description:BACKGROUND:Intraoperative hypotension is associated with postoperative mortality. Early detection of hypotension by continuous hemodynamic monitoring might prompt timely therapy, thereby reducing intraoperative hypotension. We tested the hypothesis that continuous noninvasive blood pressure monitoring reduces intraoperative hypotension. METHODS:Patients ?45 years old with American Society of Anesthesiologists physical status III or IV having moderate-to-high-risk noncardiac surgery with general anesthesia were included. All participating patients had continuous noninvasive hemodynamic monitoring using a finger cuff (ClearSight, Edwards Lifesciences, Irvine, CA) and a standard oscillometric cuff. In half the patients, randomly assigned, clinicians were blinded to the continuous values, whereas the others (unblinded) had access to continuous blood pressure readings. Continuous pressures in both groups were used for analysis. Time-weighted average for mean arterial pressure <65 mm Hg was compared using 2-sample Wilcoxon rank-sum tests and Hodges Lehmann estimation of location shift with corresponding asymptotic 95% CI. RESULTS:Among 320 randomized patients, 316 were included in the intention-to-treat analysis. With 158 patients in each group, those assigned to continuous blood pressure monitoring had significantly lower time-weighted average mean arterial pressure <65 mm Hg, 0.05 [0.00, 0.22] mm Hg, versus intermittent blood pressure monitoring, 0.11 [0.00, 0.54] mm Hg (P = .039, significance criteria P < .048). CONCLUSIONS:Continuous noninvasive hemodynamic monitoring nearly halved the amount of intraoperative hypotension. Hypotension reduction with continuous monitoring, while statistically significant, is currently of uncertain clinical importance.
| S-EPMC6072385 | biostudies-literature
Project description:ImportancePostoperative delirium occurs in 10% to 60% of elderly patients having major surgery and is associated with longer hospital stays, increased hospital costs, and 1-year mortality. Emerging literature suggests that dexmedetomidine sedation in critical care units is associated with reduced incidence of delirium. However, intraoperative use of dexmedetomidine for prevention of delirium has not been well studied.ObjectiveTo evaluate whether an intraoperative infusion of dexmedetomidine reduces postoperative delirium.Design, setting, and participantsThis study was a multicenter, double-blind, randomized, placebo-controlled trial that randomly assigned patients to dexmedetomidine or saline placebo infused during surgery and for 2 hours in the recovery room. Patients were assessed daily for postoperative delirium (primary outcome) and secondarily for postoperative cognitive decline. Participants were elderly (>68 years) patients undergoing major elective noncardiac surgery. The study dates were February 2008 to May 2014.InterventionsDexmedetomidine infusion (0.5 µg/kg/h) during surgery and up to 2 hours in the recovery room.Main outcomes and measuresThe primary hypothesis tested was that intraoperative dexmedetomidine administration would reduce postoperative delirium. Secondarily, the study examined the correlation between dexmedetomidine use and postoperative cognitive change.ResultsIn total, 404 patients were randomized; 390 completed in-hospital delirium assessments (median [interquartile range] age, 74.0 [71.0-78.0] years; 51.3% [200 of 390] female). There was no difference in postoperative delirium between the dexmedetomidine and placebo groups (12.2% [23 of 189] vs 11.4% [23 of 201], P = .94). After adjustment for age and educational level, there was no difference in the postoperative cognitive performance between treatment groups at 3 months and 6 months. Adverse events were comparably distributed in the treatment groups.Conclusions and relevanceIntraoperative dexmedetomidine does not prevent postoperative delirium. The reduction in delirium previously demonstrated in numerous surgical intensive care unit studies was not observed, which underscores the importance of timing when administering the drug to prevent delirium.Trial registrationclinicaltrials.gov Identifier NCT00561678.
| S-EPMC5831461 | biostudies-literature
Project description:BACKGROUND:Use of minimally invasive surgical techniques for lung resection surgery (LRS), such as video-assisted thoracoscopy (VATS), has increased in recent years. However, there is little information about the best anesthetic technique in this context. This surgical approach is associated with a lower intensity of postoperative pain, and its use has been proposed in programs for enhanced recovery after surgery (ERAS). This study compares the severity of postoperative complications in patients undergoing LRS who have received lidocaine intraoperatively either intravenously or via paravertebral administration versus saline. METHODS/DESIGN:We will conduct a single-center randomized controlled trial involving 153 patients undergoing LRS through a thoracoscopic approach. The patients will be randomly assigned to one of the following study groups: intravenous lidocaine with more paravertebral thoracic (PVT) saline, PVT lidocaine with more intravenous saline, or intravenous remifentanil with more PVT saline. The primary outcome will be the comparison of the postoperative course through Clavien-Dindo classification. Furthermore, we will compare the perioperative pulmonary and systemic inflammatory response by monitoring biomarkers in the bronchoalveolar lavage fluid and blood, as well as postoperative analgesic consumption between the three groups of patients. We will use an ANOVA to compare quantitative variables and a chi-squared test to compare qualitative variables. DISCUSSION:The development of less invasive surgical techniques means that anesthesiologists must adapt their perioperative management protocols and look for anesthetic techniques that provide good analgesic quality and allow rapid rehabilitation of the patient, as proposed in the ERAS protocols. The administration of a continuous infusion of intravenous lidocaine has proven to be useful and safe for the management of other types of surgery, as demonstrated in colorectal cancer. We want to know whether the continuous administration of lidocaine by a paravertebral route can be substituted with the intravenous administration of this local anesthetic in a safe and effective way while avoiding the risks inherent in the use of regional anesthetic techniques. In this way, this technique could be used in a safe and effective way in ERAS programs for pulmonary resection. TRIAL REGISTRATION:EudraCT, 2016-004271-52; ClinicalTrials.gov, NCT03905837 . Protocol number IGGFGG-2016 version 4.0, 27th April 2017.
| S-EPMC6836654 | biostudies-literature
Project description:ImportanceIntraoperative hypotension is associated with increased morbidity and mortality. A machine learning-derived early warning system to predict hypotension shortly before it occurs has been developed and validated.ObjectiveTo test whether the clinical application of the early warning system in combination with a hemodynamic diagnostic guidance and treatment protocol reduces intraoperative hypotension.Design, setting, and participantsPreliminary unblinded randomized clinical trial performed in a tertiary center in Amsterdam, the Netherlands, among adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019. Hypotension was defined as a mean arterial pressure (MAP) below 65 mm Hg for at least 1 minute.InterventionsPatients were randomly assigned to receive either the early warning system (n = 34) or standard care (n = 34), with a goal MAP of at least 65 mm Hg in both groups.Main outcomes and measuresThe primary outcome was time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury. This was calculated as the depth of hypotension below a MAP of 65 mm Hg (in millimeters of mercury) × time spent below a MAP of 65 mm Hg (in minutes) divided by total duration of operation (in minutes).ResultsAmong 68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women). The median length of surgery was 256 minutes (IQR, 213-430 minutes). The median time-weighted average of hypotension was 0.10 mm Hg (IQR, 0.01-0.43 mm Hg) in the intervention group vs 0.44 mm Hg (IQR, 0.23-0.72 mm Hg) in the control group, for a median difference of 0.38 mm Hg (95% CI, 0.14-0.43 mm Hg; P = .001). The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group, for a median difference of 16.7 minutes (95% CI, 7.7-31.0 minutes; P < .001). In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.Conclusions and relevanceIn this single-center preliminary study of patients undergoing elective noncardiac surgery, the use of a machine learning-derived early warning system compared with standard care resulted in less intraoperative hypotension. Further research with larger study populations in diverse settings is needed to understand the effect on additional patient outcomes and to fully assess safety and generalizability.Trial registrationClinicalTrials.gov Identifier: NCT03376347.
| S-EPMC7078808 | biostudies-literature
Project description:PurposePostoperative cognitive dysfunction (POCD) occurs frequently after cardiac surgery. The pathophysiology of POCD remains elusive, but previous work showed that intravenous lidocaine may be protective against POCD, possibly by modulating cerebral inflammation. We hypothesized that intravenous lidocaine would attenuate the cerebral inflammatory response to cardiopulmonary bypass (CPB) by reducing the transcerebral activation gradients of platelets, leukocytes, and/or platelet-leukocyte conjugates.MethodsWe studied 202 patients undergoing cardiac surgery with CPB in this prospective randomized double-blinded placebo-controlled trial. Subjects were randomized to receive either intravenous lidocaine (bolus + 48-hr infusion) or placebo (identical infusion volume and duration). Paired jugular venous and radial arterial blood samples were drawn at several time points and analyzed by fluorescence-activated cell sorting to identify activated platelets and platelet-leukocyte conjugates. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups using repeated measures regression models with covariate adjustment for age, sex, surgery type, and CPB duration.ResultsBeginning after aortic cross-clamp release and peaking ten minutes after the termination of CPB, the mean (SD) transcerebral activation gradient of platelet-monocyte conjugates decreased in lidocaine-treated vs placebo-treated patients [-1.84 (11.47) mean linear fluorescence intensity (MLFI) vs 1.46 (13.88) MLFI, respectively; mean difference, -4.08 MLFI; 95% confidence interval, -7.86 to -0.29; P = 0.03). No difference was seen at any time point for activated platelets or for platelet-neutrophil conjugates.ConclusionWhile lidocaine did not affect the systemic or transcerebral activation of platelets or leukocytes, we did observe a reduction in the transcerebral activation of platelet-monocyte conjugates after aortic cross-clamp release. This may be a manifestation of reduced cerebral inflammation during cardiopulmonary bypass in response to treatment with lidocaine. This trial was registered at ClinicalTrials.gov (NCT00938964).
| S-EPMC7097969 | biostudies-literature
Project description:BackgroundObesity is associated with a chronic systemic inflammatory process. Volatile or intravenous anesthetic agents may modulate immune function, and may do so differentially in obesity. However, no study has evaluated whether these potential immunomodulatory effects differ according to type of anesthesia in obese patients undergoing laparoscopic bariatric surgery.Methods/designThe OBESITA trial is a prospective, nonblinded, single-center, randomized, controlled clinical pilot trial. The trial will include 48 patients with a body mass index ≥ 35 kg/m2, scheduled for laparoscopic bariatric surgery using sleeve or a Roux-en-Y gastric bypass technique, who will be allocated 1:1 to undergo general inhalational anesthesia with sevoflurane or total intravenous anesthesia (TIVA) with propofol. The primary endpoint is the difference in plasma interleukin (IL)-6 levels when comparing the two anesthetic agents. Blood samples will be collected prior to anesthesia induction (baseline), immediately after anesthetic induction, and before endotracheal extubation. Levels of other proinflammatory and anti-inflammatory cytokines, neutrophil chemotaxis, macrophage differentiation, phagocytosis, and occurrence of intraoperative and postoperative complications will also be evaluated.DiscussionTo our knowledge, this is the first randomized clinical trial designed to compare the effects of two different anesthetics on immunomodulation in obese patients undergoing laparoscopic bariatric surgery. Our hypothesis is that anesthesia with sevoflurane will result in a weaker proinflammatory response compared to anesthesia with propofol, with lower circulating levels of IL-6 and other proinflammatory mediators, and increased macrophage differentiation into the M2 phenotype in adipose tissue.Trial registrationRegistro Brasileiro de Ensaios Clínicos, RBR-77kfj5 . Registered on 25 July 2018.
| S-EPMC6540380 | biostudies-literature