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Hyperoxia and Antioxidants for Myocardial Injury in Noncardiac Surgery: A 2 × 2 Factorial, Blinded, Randomized Clinical Trial.
Holse, C, Aasvang, EK, Vester-Andersen, M, Rasmussen, LS, Wetterslev, J, Christensen, R, Jorgensen, LN, Pedersen, SS, Loft, FC, Troensegaard, H, et al
Anesthesiology. 2022;(3):408-419
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BACKGROUND Hyperoxia and oxidative stress may be associated with increased risk of myocardial injury. The authors hypothesized that a perioperative inspiratory oxygen fraction of 0.80 versus 0.30 would increase the degree of myocardial injury within the first 3 days of surgery, and that an antioxidant intervention would reduce degree of myocardial injury versus placebo. METHODS A 2 × 2 factorial, randomized, blinded, multicenter trial enrolled patients older than 45 yr who had cardiovascular risk factors undergoing major noncardiac surgery. Factorial randomization allocated patients to one of two oxygen interventions from intubation and at 2 h after surgery, as well as antioxidant intervention or matching placebo. Antioxidants were 3 g IV vitamin C and 100 mg/kg N-acetylcysteine. The primary outcome was the degree of myocardial injury assessed by the area under the curve for high-sensitive troponin within the first 3 postoperative days. RESULTS The authors randomized 600 participants from April 2018 to January 2020 and analyzed 576 patients for the primary outcome. Baseline and intraoperative characteristics did not differ between groups. The primary outcome was 35 ng · day/l (19 to 58) in the 80% oxygen group; 35 ng · day/l (17 to 56) in the 30% oxygen group; 35 ng · day/l (19 to 54) in the antioxidants group; and 33 ng · day/l (18 to 57) in the placebo group. The median difference between oxygen groups was 1.5 ng · day/l (95% CI, -2.5 to 5.3; P = 0.202) and -0.5 ng · day/l (95% CI, -4.5 to 3.0; P = 0.228) between antioxidant groups. Mortality at 30 days occurred in 9 of 576 patients (1.6%; odds ratio, 2.01 [95% CI, 0.50 to 8.1]; P = 0.329 for the 80% vs. 30% oxygen groups; and odds ratio, 0.79 [95% CI, 0.214 to 2.99]; P = 0.732 for the antioxidants vs. placebo groups). CONCLUSIONS Perioperative interventions with high inspiratory oxygen fraction and antioxidants did not change the degree of myocardial injury within the first 3 days of surgery. This implies safety with 80% oxygen and no cardiovascular benefits of vitamin C and N-acetylcysteine in major noncardiac surgery.
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Perioperative probiotic treatment decreased the incidence of postoperative cognitive impairment in elderly patients following non-cardiac surgery: A randomised double-blind and placebo-controlled trial.
Wang, P, Yin, X, Chen, G, Li, L, Le, Y, Xie, Z, Ouyang, W, Tong, J
Clinical nutrition (Edinburgh, Scotland). 2021;(1):64-71
Abstract
BACKGROUND Given that population aging is a global health challenge, the high prevalence of postoperative neurocognitive impairment in elderly patients necessitates the development of novel simple and effective prevention methods. OBJECTIVE To evaluate the effects of perioperative application of oral probiotic as a prophylaxis for cognitive impairment in elderly patients following non-cardiac surgery. METHODS This randomised double-blind and placebo-controlled trial included 120 elderly patients (in a modified intention-to-treat analysis) scheduled for elective orthopaedic or colorectal surgery. Patients were assigned to receive either probiotics or a placebo from hospital admission until discharge. The primary endpoint was the incidence of postoperative cognitive impairment, defined as a decrease of ≥3 points in the Mini-Mental State Examination (MMSE) scores from admission baseline to the 7th day post-surgery. Secondary endpoints included changes in plasma interleukin-6 (IL-6) and cortisol, postoperative pain intensity, postoperative sleep quality, gastrointestinal function recovery, and faecal microbiota composition. RESULTS The incidence of postoperative cognitive impairment in the probiotic group was significantly lower than in the control group (3 of 59 patients [5.1%] vs. 10 of 61 patients [16.4%], P = 0.046). In addition, compared to pre-surgery, the levels of plasma IL-6 and cortisol in the probiotic group decreased more than in the control group 5-7 days after surgery (IL-6: -117.90 ± 49.15 vs. -14.93 ± 15.21, P = 0.044; cortisol: -158.70 ± 53.52 vs. 40.98 ± 72.48, P = 0.010). Relative abundance at the genus level in the faeces of the probiotic group also changed more than in that of the control group during the perioperative period. In contrast, postoperative pain intensity, sleep quality, and gastrointestinal function recovery did not differ significantly between the two groups. CONCLUSION Perioperative application of oral probiotic prevents postoperative cognitive impairment in elderly patients following non-cardiac surgery, possibly via the limitation of peripheral inflammation and the stress response.
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The effect of glucose control in liver surgery on glucose kinetics and insulin resistance.
Blixt, C, Larsson, M, Isaksson, B, Ljungqvist, O, Rooyackers, O
Clinical nutrition (Edinburgh, Scotland). 2021;(7):4526-4534
Abstract
BACKGROUND & AIMS Clinical outcome is negatively correlated to postoperative insulin resistance and hyperglycemia. The magnitude of insulin resistance can be modulated by glucose control, preoperative nutrition, adequate pain management and minimal invasive surgery. Effects of glucose control on perioperative glucose kinetics in liver surgery is less studied. METHODS 18 patients scheduled for open hepatectomy were studied per protocol in this prospective, randomized study. In the treatment group (n = 9), insulin was administered intravenously to keep arterial blood glucose between 6 and 8 mmol/l during surgery. The control group (n = 9) received insulin if blood glucose >11.5 mmol/l. Insulin sensitivity was measured by an insulin clamp on the day before surgery and immediately postoperatively. Glucose kinetics were assessed during the clamp and surgery. RESULTS Mean intraoperative glucose was 7.0 mM (SD 0.7) vs 9.1 mM (SD 1.9) in the insulin and control group respectively (p < 0.001; ANOVA). Insulin sensitivity decreased in both groups but significantly (p = 0.03, ANOVA) more in the control group (M value: 4.6 (4.4-6.8) to 2.1 (1.2-2.6) and 4.6 (4.1-5.0) to 0.6 (0.1-1.8) mg/kg/min in the treatment and control group respectively). Endogenous glucose production (EGP) increased and glucose disposal (WGD) decreased significantly between the pre- and post-operative clamps in both groups, with no significant difference between the groups. Intraoperative kinetics demonstrated that glucose control decreased EGP (p = 0.02) while WGD remained unchanged (p = 0.67). CONCLUSION Glucose control reduces postoperative insulin resistance in liver surgery. EGP increases and WGD is diminished immediately postoperatively. Insulin seems to modulate both reactions, but mostly the WGD is affected. Intraoperative EGP decreased while WGD remained unaltered. REGISTRATION NUMBER OF CLINICAL TRIAL ANZCTR 12614000278639.
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Surgical Outcome Results From SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma.
Ahmad, SA, Duong, M, Sohal, DPS, Gandhi, NS, Beg, MS, Wang-Gillam, A, Wade, JL, Chiorean, EG, Guthrie, KA, Lowy, AM, et al
Annals of surgery. 2020;(3):481-486
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OBJECTIVE The optimal neoadjuvant therapy for resectable pancreatic ductal adenocarcinoma (PDA) and the impact on surgical outcomes remains unclear. METHODS S1505 (NCT02562716) was a randomized phase II study of perioperative chemotherapy with mFOLFIRINOX (Arm 1) or gemcitabine/nab-paclitaxel (Arm 2). Measured parameters included resection rate, margin positivity, pathologic response, and toxicity. RESULTS Between 2015 and 2018, 147 patients were randomized. Of these, 44 (30%) were deemed ineligible (43 by central review). Of the 103 eligible patients, 77 (76%) completed preoperative therapy and underwent surgery; reasons patients did not undergo surgery included toxicity related to preoperative therapy (n = 9), progression (n = 9), or other (n = 7). Of the 77, 73 (95%) underwent successful resection; 21 (29%) required vascular reconstruction, 62 (85%) had negative (R0) margins, and 24 (33%) had a complete or major pathologic response to therapy. The grade 3-5 postoperative complication rate was 16%. Of the 73 patients completing surgery, 57 (78%) started and 46 (63%) completed postoperative therapy. This study represents the first prospective trial evaluating modern systemic therapy delivered in a neoadjuvant/perioperative format for resectable PDA. CONCLUSIONS We have demonstrated: (1) Based on the high percentage of enrolled, but ineligible patients, it is clear that adherence to strict definitions of resectable PDA is challenging; (2) Patients can tolerate modern systemic therapy and undergo successful surgical resection without prohibitive perioperative complications; (3) Completion of adjuvant therapy in the perioperative format is difficult; (4) Major pathologic response rate of 33% is encouraging.
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Perioperative multi-system optimization protocol in elderly hip fracture patients: a randomized-controlled trial.
Schmid, S, Blobner, M, Haas, B, Lucke, M, Neumaier, M, Anetsberger, A, Jungwirth, B
Canadian journal of anaesthesia = Journal canadien d'anesthesie. 2019;(12):1472-1482
Abstract
PURPOSE Hip fractures in elderly patients are associated with increased postoperative morbidity and mortality. We evaluated whether a perioperative multi-system optimization protocol can reduce postoperative complications in these patients. METHODS Immediately after diagnosis of hip fracture, patients ≥ 60 yr were randomized to an intervention or control group. Patients in the intervention group were admitted to our postanesthesia care unit where they were treated with goal-directed hemodynamic management, optimized pain therapy, oxygen therapy, and optimized nutrition. Patients in the control group were managed according to our usual standard of care on a regular ward. Postoperative complications during hospital stay included pre-determined cardiovascular, respiratory, neurologic, renal, or surgical events. RESULTS The incidence of at least one postoperative complication (primary outcome) was seen in 32 of 65 (49%) controls compared with 24 of 62 (39%) in the intervention group (relative risk [RR], 0.79; 95% confidence interval [CI], 0.53 to 1.17; P = 0.23). The secondary unadjusted outcomes showed that patients in the intervention group received more Ringer's acetate compared with controls (median difference, 1.3 L; 95% CI, 0.6 to 2.1 L; P < 0.001), had more frequently a mean arterial pressure > 70 mmHg (57% control vs 75% intervention; median percentage difference, 16%; 95% CI, 7 to 25%; P = 0.001), better pain control (numeric rating scale < 4 at all postoperative measurements; 25% control vs 81% intervention; RR, 0.26; 95% CI, 0.15 to 0.43; P < 0.001), and possibly a lower incidence of acute renal failure (RR, 0.37; 95% CI, 0.14 to 0.98; P = 0.04). CONCLUSIONS The implementation of a perioperative multi-system optimization protocol algorithm did not significantly reduce the risk of postoperative complications. Nevertheless, we likely over-estimated the potential treatment effect in our study design and thus were under-powered to show an effect. TRIAL REGISTRATION Clinicaltrials.gov (NCT01673776). Registered 23 August, 2012.
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The effect of perioperative magnesium sulfate on blood sugar in patients with diabetes mellitus undergoing cardiac surgery: A double-blinded randomized study.
Soliman, R, Nofal, H
Annals of cardiac anaesthesia. 2019;(2):151-157
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OBJECTIVE The aim of the present study was to evaluate the perioperative effect of magnesium infusion on blood sugar level in patients with diabetes mellitus undergoing cardiac surgery. DESIGN This was a double-blind randomized study. SETTING The study was conducted at cardiac center. PATIENTS The study included 122 adult patients. INTERVENTION Group M - The patients received a continuous infusion of magnesium sulfate (without a loading dose) at 15 mg/kg/h. The infusion rate was started 20 min before induction maintained during surgery and the first postoperative 24 h. The medication was prepared by adding 5 g magnesium sulfate in 50 ml syringe. Group C - The patients received equal amount of normal saline. MEASUREMENTS The monitors included heart rate, mean arterial blood pressure, central venous pressure, urine output, blood levels of magnesium, sugar, and potassium. RESULTS The blood sugar level and the required insulin significantly decreased with Group M than Group C (P < 0.05). There were minimal changes in the potassium level in Group M, but potassium decreased in patients of Group C (P < 0.05). The amount of urine output was too much higher in Group M than Group C (P < 0.05). The pharmacological and mechanical support significantly decreased with Group M than Group C (P < 0.05). The hospital and Intensive Care Unit length of stay significantly decreased with Group M than Group C (P < 0.05). CONCLUSION The magnesium sulfate produced a better-controlled effect on the blood sugar level. It decreased the requirement of insulin infusion and minimized the changes in the blood level of potassium.
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Clinical Application of Enhanced Recovery After Surgery in Perioperative Period of Laparoscopic Colorectal Cancer Surgery.
Li, Q, Du, L, Lu, L, Tong, Y, Wu, S, Yang, Y, Hu, Q, Wang, Y
Journal of laparoendoscopic & advanced surgical techniques. Part A. 2019;(2):178-183
Abstract
OBJECTIVE To investigate the clinical application value of enhanced recovery after surgery (ERAS) combined with the laparoscopic technique in the radical resection of colorectal cancer. METHODS A total of 200 patients undergoing laparoscopic radical surgery for colorectal cancer from June 2014 to June 2017 were selected and randomly divided into ERAS group (n = 100) and conventional (CON) group (n = 100). The ERAS group adopted enhanced recovery approach after surgery for perioperative treatment, while the CON group adopted a CON approach. The operation time, blood loss, first exhaust time, first defecation time, extubation time, complication rate (incision infection, pneumonia, gastric retention, anastomotic leakage, intestinal obstruction, etc.), scores of visual analog scale (VAS) 1, 3, and 7 days after surgery, and nutritional status (albumin, total protein) 1, 3, and 7 days after surgery were compared and analyzed. RESULTS Compared with the CON group, the ERAS group had significantly shorter first exhaust time, first defecation time, and extubation time (all P < .05). The incidence of overall complications in the ERAS group was less than those in the CON group (P < .05); and albumin and total protein were significantly higher in the ERAS group than in the CON group (both P < .05). CONCLUSIONS ERAS combined with laparoscopic techniques for the treatment of colorectal cancer is a safe and feasible practice. It not only promoted the recovery of gastrointestinal function but also improved the perioperative nutritional status of patients.
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Balanced Crystalloids Versus Saline for Perioperative Intravenous Fluid Administration in Children Undergoing Neurosurgery: A Randomized Clinical Trial.
Lima, MF, Neville, IS, Cavalheiro, S, Bourguignon, DC, Pelosi, P, Malbouisson, LMS
Journal of neurosurgical anesthesiology. 2019;(1):30-35
Abstract
BACKGROUND Balanced crystalloid solutions induce less hyperchloremia than normal saline, but their role as primary fluid replacement for children undergoing surgery is unestablished. We hypothesized that balanced crystalloids induce less chloride and metabolic derangements than 0.9% saline solutions in children undergoing brain tumor resection. METHODS In total, 53 patients (age range, 6 mo to 12 y) were randomized to receive balanced crystalloid (balanced group) or 0.9% saline solution (saline group) during and after (for 24 h) brain tumor resection. Serum electrolyte and arterial blood gas analyses were performed at the beginning of surgery (baseline), after surgery, and at postoperative day 1. The primary trial outcome was the absolute difference in serum chloride concentrations (post-preopΔCl) measured after surgery and at baseline. Secondary outcomes included the post-preopΔ of other electrolytes and base excess (BE); hyperchloremic acidosis incidence; and the brain relaxation score, a 4-point scale evaluated by the surgeon for assessing brain edema. RESULTS Saline infusion increased post-preopΔCl (6 [3.5; 8.5] mmol/L) compared with balanced crystalloid (0 [-1.0; 3.0] mmol/L; P<0.001). Saline use also resulted in increased post-preopΔBE (-4.4 [-5.0; -2.3] vs. -0.4 [-2.7; 1.3] mmol/L; P<0.001) and hyperchloremic acidosis incidence (6/25 [24%] vs. 0; P=0.022) compared with balanced crystalloid. Brain relaxation score was comparable between groups. CONCLUSIONS In children undergoing brain tumor resection, saline infusion increased variation in serum chloride compared with balanced crystalloid. These findings support the use of balanced crystalloid solutions in children undergoing brain tumor resection.
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Glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in patients with type 2 diabetes undergoing non-cardiac surgery: A multicentre randomized clinical trial.
Vellanki, P, Rasouli, N, Baldwin, D, Alexanian, S, Anzola, I, Urrutia, M, Cardona, S, Peng, L, Pasquel, FJ, Umpierrez, GE, et al
Diabetes, obesity & metabolism. 2019;(4):837-843
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AIMS: The use of incretin-based therapy, rather than or complementary to, insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined the glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in hospitalized surgical patients with T2D. MATERIALS AND METHODS This prospective open-label multicentre study randomized T2D patients undergoing non-cardiac surgery with admission blood glucose (BG) of 7.8 to 22.2 mmol/L who were under treatment with diet, oral agents or total insulin dose (TDD) ≤ 0.5 units/kg/day to either linagliptin (n = 128) daily or basal-bolus (n = 122) with glargine once daily and rapid-acting insulin before meals. Both groups received supplemental insulin for BG > 7.8 mmol/L. The primary endpoint was difference in mean daily BG between groups. RESULTS Mean daily BG was higher in the linagliptin group compared to the basal-bolus group (9.5 ± 2.6 vs 8.8 ± 2.3 mmol/L/dL, P = 0.03) with a mean daily BG difference of 0.6 mmol/L (95% confidence interval 0.04, 1.2). In patients with randomization BG < 11.1 mmol/L (63% of cohort), mean daily BG was similar in the linagliptin and basal-bolus groups (8.9 ± 2.3 vs 8.7 ± 2.3 mmol/L, P = 0.43); however, patients with BG ≥ 11.1 mmol/L who were treated with linagliptin had higher BG compared to the basal-bolus group (10.9 ± 2.6 vs 9.2 ± 2.2 mmol/L, P < 0.001). Linagliptin resulted in fewer hypoglycaemic events (1.6% vs 11%, P = 0.001; 86% relative risk reduction), with similar supplemental insulin and fewer daily insulin injections (2.0 ± 3.3 vs 3.1 ± 3.3, P < 0.001) compared to the basal-bolus group. CONCLUSIONS For patients with T2D undergoing non-cardiac surgery who presented with mild to moderate hyperglycaemia (BG < 11.1 mmol/L), daily linagliptin is a safe and effective alternative to multi-dose insulin therapy, resulting in similar glucose control with lower hypoglycaemia.
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Enhanced recovery care versus traditional care after laparoscopic liver resections: a randomized controlled trial.
Liang, X, Ying, H, Wang, H, Xu, H, Liu, M, Zhou, H, Ge, H, Jiang, W, Feng, L, Liu, H, et al
Surgical endoscopy. 2018;(6):2746-2757
Abstract
BACKGROUND Enhanced recovery after surgery (ERAS), with several evidence-based elements, has been shown to shorten length of hospital stay and reduce perioperative hospital costs in many operations. This randomized clinical trial was performed to compare complications and hospital stay of laparoscopic liver resection between ERAS and traditional care. METHODS A randomized controlled trial was performed for laparoscopic liver resection from August 2015 to August 2016. Patients were randomly divided into ERAS group and traditional care group. The primary outcome was length of hospital stay (LOS) after surgery. Second outcomes included postoperative complications, hospital cost, and 30-day readmissions. Elements used in ERAS group included more perioperative education, nurse navigators, nutrition support for liver diseases, respiratory therapy, oral carbohydrate 2 h before operation, early mobilization and oral intake, goal-directed fluid therapy, less drainages, postoperative nausea and vomiting (PONV) prophylaxis and multimodal analgesia. RESULTS The study included 58 (two conversion to laparotomy) patients in ERAS group and 61 (three conversion to laparotomy) patients in the traditional care group. Postoperative LOS was significantly shorter in the ERAS group than traditional care group (5 vs. 8 days; p < 0.001). ERAS program significantly reduced the hospital costs (CNY 45413.1 vs. 55794.1; p = 0.006) and complications (36.2 vs. 55.7%; p = 0.033). Duration till first flatus and PONV were significantly reduced in ERAS group. Pain control was better in ERAS (Visual analogue scale (VAS) POD1 (≥ 4) 19.0 vs. 39.3%, p = 0.017; VAS POD1 2.5 vs. 3.1, p = 0.010). There was no difference in the rate of 30-day readmissions (6.9 vs. 8.2%; p = 1.000). CONCLUSION ERAS protocol is feasible and safe for laparoscopic liver resection. Patients in ERAS group have less pain and complications.