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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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Nitric oxide delivery during cardiopulmonary bypass reduces acute kidney injury: A randomized trial.
Kamenshchikov, NO, Anfinogenova, YJ, Kozlov, BN, Svirko, YS, Pekarskiy, SE, Evtushenko, VV, Lugovsky, VA, Shipulin, VM, Lomivorotov, VV, Podoksenov, YK
The Journal of thoracic and cardiovascular surgery. 2022;(4):1393-1403.e9
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OBJECTIVE Acute kidney injury (AKI) is a serious complication of cardiac surgery with cardiopulmonary bypass (CPB). The aim of this study was to evaluate the effects of nitric oxide (NO) supplementation to the CPB circuit on the development of cardiac surgery-associated AKI. METHODS This prospective randomized controlled study included 96 patients with moderate risk of renal complications who underwent elective cardiac surgery with CPB. The study protocol was registered at ClinicalTrials.gov (identifier NCT03527381). Patients were randomly allocated to either NO supplementation to the CPB bypass circuit (NO treatment group; n = 48) or usual care (control group; n = 48). In the NO treatment group, 40-ppm NO was administered during the entire CPB period. The primary outcome was the incidence of AKI. RESULTS NO treatment was associated with a significant decrease in AKI incidence (10 cases [20.8%] vs 20 cases [41.6%] in the control group; relative risk, 0.5; 95% confidence interval, 0.26-0.95; P = .023) and a higher median urine output during CPB (2.6 mL/kg/h [interquartile range (IQR), 2.1-5.08 mL/kg/h] vs 1.7 mL/kg/h [IQR, 0.80-2.50 mL/kg/h]; P = .0002). The median urinary neutrophil gelatinase-associated lipocalin level at 4 hours after surgery was significantly lower in the NO treatment group (1.12 ng/mL [IQR, 0.75-5.8 ng/mL] vs 4.62 ng/mL [IQR, 2.02-34.55 ng/mL]; P = .005). In the NO treatment group, concentrations of NO metabolites were significantly increased at 5 minutes postclamping, at 5 minutes after declamping, and at the end of the operation. Concentrations of proinflammatory and anti-inflammatory mediators and free plasma hemoglobin did not differ significantly between the 2 groups. CONCLUSIONS NO administration in patients at moderate risk of renal complications undergoing elective cardiac surgery with CPB was associated with a lower incidence of AKI.
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Assessment of Body Composition as an Indicator of Early Peripheral Parenteral Nutrition Therapy in Patients Undergoing Colorectal Cancer Surgery in an Enhanced Recovery Program.
López-Rodríguez-Arias, F, Sánchez-Guillén, L, Lillo-García, C, Aranaz-Ostáriz, V, Alcaide, MJ, Soler-Silva, Á, Soriano-Irigaray, L, Barber, X, Arroyo, A
Nutrients. 2021;(9)
Abstract
BACKGROUND A poor body composition (BC) has been identified as a risk factor for patients with colorectal cancer (CRC). This study was performed to assess the effect of early peripheral parenteral nutrition (PPN) on BC in patients undergoing CCR surgery within an enhanced recovery program. METHODS Patients with normal nutritional status were prospectively included between October 2016 and September 2019, randomized into two groups (PPN with periOlimel N4-E versus conventional fluid therapy) and subsequently classified according to their preoperative CT scan into high- or low-risk BC groups. Postoperative complications and length of hospital stay (LOS) were assessed. RESULTS Of the 156 patients analyzed, 88 patients (56.4%) were classified as having high-risk BC according to CT measurements. PPN led to a 15.4% reduction in postoperative complications in high-risk vs. 1.7% in low-risk BC patients. In the multivariate analysis, high-risk BC was related to an OR (95% CI) of 2 (p = 0.044) of presenting complications and of 1.9 (p = 0.066) for major complications, and was associated with an increase in LOS of 3.6 days (p = 0.039). CONCLUSIONS The measurement of patients' BC can allow for the identification of target patients where PPN has been proven to be an effective tool to improve postoperative outcomes.
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Use of Prophylactic Steroids to Prevent Hypocalcemia and Voice Dysfunction in Patients Undergoing Thyroidectomy: A Randomized Clinical Trial.
Dhahri, AA, Ahmad, R, Rao, A, Bhatti, D, Ahmad, SH, Ghufran, S, Kirmani, N
JAMA otolaryngology-- head & neck surgery. 2021;(10):866-870
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IMPORTANCE Total thyroidectomy is associated with risks related to temporary hypocalcemia and vocal quality dysfunction. Dexamethasone has been proposed to have a physiological effect on hypocalcemia and voice quality. OBJECTIVE To assess the effect of preoperative dexamethasone used to improve hypocalcemia and postthyroidectomy voice dysfunction. DESIGN, SETTING, AND PARTICIPANTS This double-blind, parallel-group, placebo-controlled randomized clinical trial was conducted from January 15, 2014, to December 31, 2019, at the Department of Surgery, Holy Family Hospital in Rawalpindi, Pakistan. All patients with a benign thyroid condition and no preoperative corrected hypocalcemia and voice or vocal quality dysfunction were included. Patients were excluded if they had previous thyroid or neck surgery, known vocal cord dysfunction on laryngoscopy, hearing or voice problems, a history of gastroesophageal reflux, stomach ulcer disease, or contraindications to steroid use. INTERVENTIONS Corrected serum calcium levels and Voice Analog Score defined and measured preoperatively. The dexamethasone group received a 2-mL intravenous dose of 8 mg of dexamethasone 60 minutes before the induction of anesthesia. In contrast, the placebo group received 2 mL of intravenous normal saline (0.9%) 60 minutes before the induction of anesthesia. MAIN OUTCOMES AND MEASURES Evidence of hypocalcemia and voice dysfunction. Voice dysfunction was defined as a subjective score of less than 50 on a Voice Analog Score scale of 0 to 100 points. RESULTS A total of 192 patients (mean [SD] age, 38.9 [12.4] years; 156 women [81.2%]) were included in the study, with 96 patients randomized to each study group (dexamethasone group, mean [SD] age, 39.2 [12.1] years; 75 women [78.1%]; placebo group, mean [SD] age, 38.5 [12.9] years; 81 women [84.5%]). In the first 24 hours after undergoing thyroidectomy, 47 patients (24.4%) developed hypocalcemia and 18 (9.4%) were symptomatic. At 3 days postthyroidectomy, 4 of 96 patients (4.2%) in the placebo group had hypocalcemia compared with no patients in the dexamethasone group. At 24 hours postthyroidectomy, 8 of 96 patients (8.3%) in the dexamethasone group had voice dysfunction compared with 32 of 96 patients (33.3%) in the placebo group. A total of 40 patients (20.8%) reported voice dysfunction. The absolute reduction in the rate of hypocalcemia at 24 hours was 24% (95% CI, 11.9%-35.2%) and at 3 days was 4.2% (-0.44% to 10.0%). The rate of symptomatic hypocalcemia was 19% lower in the dexamethasone group than in the placebo group (95% CI, 11.1%-27.7%). The rate of voice dysfunction was 25% lower in the dexamethasone group than in the placebo group (95% CI, 13.7%-35.7%). CONCLUSIONS AND RELEVANCE In this randomized clinical trial, a single preoperative dose of dexamethasone was safe and effective in reducing postoperative hypocalcemia and voice dysfunction rates in patients undergoing thyroidectomy. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT04752852.
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The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.
Weinberg, L, Li, MH, Churilov, L, Macgregor, C, Garrett, K, Eyles, J, Bellomo, R
PloS one. 2021;(5):e0251718
Abstract
OBJECTIVES Saline and Plasma-Lyte have different physiochemical contents; consequently, they may differently affect patients' renal function. We compared the effects of fluid therapy with 0.9% saline and with Plasma-Lyte 148 on renal function as assessed by creatinine concentration among patients undergoing major surgery. METHODS We conducted a prospective, double-blinded cluster crossover trial comparing the effects of the two fluids on major surgery patients. The primary aim was to establish the pilot feasibility, safety and preliminary efficacy evidence base for a large interventional trial to establish whether saline or Plasma-Lyte is the preferred crystalloid fluid for managing major surgery patients. The primary efficacy outcome was the proportion of patients with changes in renal function as assessed by creatinine concentration during their index hospital admission. We used changes in creatinine to define acute kidney injury (AKI) according to the RIFLE criteria. RESULTS The study was feasible with 100% patient and clinician acceptance. There were no deviations from the trial protocol. After screening, we allocated 602 patients to saline and 458 to Plasma-Lyte. The median (IQR) volume of intraoperative fluid received was 2000 mL (1000:2000) in both groups. Forty-nine saline patients (8.1%) and 49 Plasma-Lyte patients (10.7%) developed a postoperative AKI (adjusted incidence rate ratio [aIRR]: 1.34; 95% CI: 0.93-1.95; p = 0.120). No differences were observed in the development of postoperative complications (aIRR: 0.98; 95% CI: 0.89-1.08) or the severity of the worst complication (aIRR: 1.00; 95% CI: 0.78-1.30). The median (IQR) length of hospital stay was six days (3:11) for the saline group and five days (3:10) for the Plasma-Lyte group (aIRR: 0.85; 95% CI: 0.73-0.98). There were no serious adverse events relating to the trial fluids, nor were there fluid crossover or contamination events. CONCLUSIONS The study design was feasible to support a future follow-up larger clinical trial. Patients treated with saline did not demonstrate an increased incidence of postoperative AKI (defined as changes in creatinine) compared to those treated with Plasma-Lyte. Our findings imply that clinicians can reasonably use either solution intraoperatively for adult patients undergoing major surgery. TRIAL REGISTRATION Registry: Australian New Zealand Clinical Trials Registry; ACTRN12613001042730; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364988.
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Immediate vs. gradual advancement to goal of enteral nutrition after elective abdominal surgery: A multicenter non-inferiority randomized trial.
Zhang, L, Liu, Y, Gao, X, Zhou, D, Zhang, Y, Tian, F, Gao, T, Wang, Y, Chen, Z, Lian, B, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(12):5802-5811
Abstract
BACKGROUND & AIMS The strategy of increasing the postoperative enteral nutrition dose to the target goal has not yet been clarified. This study aimed to determine whether an immediate goal-dose enteral nutrition (IGEN) strategy is non-inferior to a gradual goal-dose enteral nutrition (GGEN) strategy in reducing infections in patients undergoing abdominal surgery involving the organs of the digestive system. METHODS This randomized controlled trial enrolled postoperative patients with nutritional risk screening 2002 scores ≥3 from 11 Chinese hospitals. Energy targets were calculated as 25 kcal/kg and 30 kcal/kg of ideal body weight for women and men, respectively. Patients were randomly assigned 1:1 to IGEN or GGEN group after enteral tolerance was confirmed (30% of the target on day 2). The IGEN group immediately started receiving 100% of the caloric requirements on day 3, while the GGEN group received 40% progressing to 80% of target on day 7. The primary endpoint was the infection rate until discharge, based on the intention-to-treat population. RESULTS A total of 411 patients were enrolled and randomized to the IGEN and GGEN groups, and five patients did not receive the allocated intervention. A total of 406 patients were included in the primary analysis, with 199 and 207 in the IGEN and GGEN groups, respectively. Infection was observed in 17/199 (8.5%) in the IGEN group and 19/207 (9.2%) in the GGEN group, respectively (difference, -0.6%; [95% confidence interval (CI), -6.2%-4.9%]; P = 0.009 for non-inferiority test). There were significantly more gastrointestinal intolerance events with IGEN than with GGEN (58/199 [29.1%] vs. 32/207 [15.5%], P < 0.001). All other secondary endpoints were non-significant. CONCLUSIONS Among postoperative patients at nutritional risk, IGEN was non-inferior to GGEN in regards to infectious complications. IGEN was associated with more gastrointestinal intolerance events. It showed that IGEN cannot be considered to be clinically directive. ClinicalTrials.gov (#NCT03117348).
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Older frail prehabilitated patients who cannot attain a 400 m 6-min walking distance before colorectal surgery suffer more postoperative complications.
Gillis, C, Fenton, TR, Gramlich, L, Sajobi, TT, Culos-Reed, SN, Bousquet-Dion, G, Elsherbini, N, Fiore, JF, Minnella, EM, Awasthi, R, et al
European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 2021;(4):874-881
Abstract
INTRODUCTION Recent efforts to prehabilitate intermediately frail and frail (Fried frailty criteria ≥2) elective colorectal cancer patients did not influence clinical nor functional outcomes. The objective of this secondary analysis was to describe the subset of intermediately frail and frail prehabilitated patients who could not attain a minimum 400 m (a prognostic cut-point used in other patient populations) 6-min walking distance (6MWD) before elective surgery. MATERIALS AND METHODS Secondary analysis of a randomized controlled trial. Patients participated in multimodal prehabilitation at home and in-hospital for approximately four weeks before colorectal surgery. Primary outcome was incidence of postoperative complications within 30 days of hospital discharge. RESULTS Sixty percent of the patients who participated in prehabilitation did not reach a minimum walking distance of 400 m in 6 min before surgery. Compared to the group that attained ≥400 m 6MWD (n = 19), the <400 m group (n = 28) were older, had higher percent body fat, lower physical function, lower self-reported physical activity, higher American Society of Anesthesiologists (ASA) classification, and twice as many were in critical need of a nutrition intervention at baseline. No group differences were observed regarding frailty status (P = 0.775). Sixty-one percent of the <400 m 6MWD group experienced at least one complication within 30 days of surgery compared to 21% in the ≥400 m group (P = 0.009). CONCLUSION Several preoperative characteristics were identified in the <400 m 6MWD group that could be useful in screening and targeting future prehabilitative treatments. Future trials should investigate use of a 400 m standard for the 6MWD as a minimal treatment target for prehabilitation.
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Preoperative carbohydrate loading and intraoperative goal-directed fluid therapy for elderly patients undergoing open gastrointestinal surgery: a prospective randomized controlled trial.
Liu, X, Zhang, P, Liu, MX, Ma, JL, Wei, XC, Fan, D
BMC anesthesiology. 2021;(1):157
Abstract
BACKGROUND The effect of a combination of a goal-directed fluid protocol and preoperative carbohydrate loading on postoperative complications in elderly patients still remains unknown. Therefore, we designed this trial to evaluate the relative impact of preoperative carbohydrate loading and intraoperative goal-directed fluid therapy versus conventional fluid therapy (CFT) on clinical outcomes in elderly patients following gastrointestinal surgery. METHODS This prospective randomized controlled trial with 120 patients over 65 years undergoing gastrointestinal surgery were randomized into a CFT group (n = 60) with traditional methods of fasting and water-deprivation, and a GDFT group (n = 60) with carbohydrate (200 ml) loading 2 h before surgery. The CFT group underwent routine monitoring during surgery, however, the GDFT group was conducted by a Vigileo/FloTrac monitor with cardiac index (CI), stroke volume variation (SVV), and mean arterial pressure (MAP). For all patients, demographic data, intraoperative parameters and postoperative outcomes were recorded. RESULTS Patients in the GDFT group received significantly less crystalloids fluid (1111 ± 442.9 ml vs 1411 ± 412.6 ml; p < 0.001) and produced significantly less urine output (200 ml [150-300] vs 400 ml [290-500]; p < 0.001) as compared to the CFT group. Moreover, GDFT was associated with a shorter average time to first flatus (56 ± 14.1 h vs 64 ± 22.3 h; p = 0.002) and oral intake (72 ± 16.9 h vs 85 ± 26.8 h; p = 0.011), as well as a reduction in the rate of postoperative complications (15 (25.0%) vs 29 (48.3%) patients; p = 0.013). However, postoperative hospitalization or hospitalization expenses were similar between groups (p > 0.05). CONCLUSIONS Focused on elderly patients undergoing open gastrointestinal surgery, we found perioperative fluid optimisation may be associated with improvement of bowel function and a lower incidence of postoperative complications. TRIAL REGISTRATION ChiCTR, ChiCTR1800018227 . Registered 6 September 2018 - Retrospectively registered.
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The safety of early administration of oral fluid following general anesthesia in children undergoing tonsillectomy: a prospective randomized controlled trial.
Wu, MH, Liu, CQ, Zeng, XQ, Jia, AN, Yin, XR
BMC anesthesiology. 2021;(1):13
Abstract
BACKGROUND The feasibility and safety of administrating a small amount of oral fluid to children in the early recovery period following tonsillectomy under general anesthesia to reduce the thirst and its associated restlessness remain unknown. METHODS This study was approved by the institutional ethics committee and adhered to the CONSORT guidelines. Pediatric patients undergoing tonsillectomy who met the inclusion and exclusion criteria of our study were randomized into the study and control groups. In the study group, patients were given a small amount of water instantly after recovering from general anesthesia, which included the recovery of the cough and deglutition reflex, and attaining grade V of muscle strength. The control group was given a small amount of water at 4 to 6 h after the operation. The incidence of nausea and vomiting and the degree of thirst relief were measured and compared between the two groups. RESULTS Three hundred patients were randomized into each group. There was no significant difference in the incidence of nausea and vomiting at 20 min after drinking water between the two groups (P > 0.05). The thirst score of children over 5 years old in the study group was significantly lower than that of the control group (P < 0.05). CONCLUSION Early administration of a small amount of oral fluid to children following tonsillectomy and recovering from general anesthesia is not only safe but also effective in reducing postoperative thirst. TRIAL REGISTRATION Current Controlled Trials ChiCTR1800020058 , 12-12-2018.
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Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial.
Lee, YS, Kim, JH, Kim, HJ, Lee, SC, Kang, BM, Kim, CW, Lim, SW, Lee, SH, Kim, JG
Annals of surgery. 2021;(2):217-223
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OBJECTIVE To compare short-term perioperative outcomes of single-port laparoscopic surgery (SPLS) and multiport laparoscopic surgery (MPLS) for colon cancer. SUMMARY BACKGROUND DATA Although many studies reported short- and long-term outcomes of SPLS for colon cancer compared with MPLS, few have reported results of randomized controlled trials. METHODS This was a multicenter, prospective, randomized controlled trial with a noninferiority design. It was conducted between August 2011 and June 2017 at 7 sites in Korea. A total of 388 adults (aged 19-85 yrs) with clinical stage I, II, or III adenocarcinoma of the ascending or sigmoid colon were enrolled and randomized. The primary endpoint was 30-day postoperative complication rates. Secondary endpoints were the number of harvested lymph nodes, length of the resection margin, postoperative pain, and time to functional recovery (bowel movement and diet). Patients were followed for 30 days after surgery. RESULTS Among 388 patients, 359 (92.5%) completed the study (SPLS, n = 179; MPLS, n = 180). The 30-day postoperative complication rate was 10.6% in the SPLS group and 13.9% in the MPLS group (95% confidence interval, -10.05 to 3.05 percentage points; P < 0.0001). Total incision length was shorter in the SPLS group than in the MPLS group (4.6 cm vs 7.2 cm, P < 0.001), whereas the length of the specimen extraction site did not differ (4.4 cm vs 4.6 cm, P = 0.249). There were no significant differences between groups for all secondary endpoints and all other outcomes. CONCLUSIONS Even though there was no obvious benefit to SPLS over MPLS when performing colectomy for cancer, our data suggest that SPLS is noninferior to MPLS and can be considered an option in selected patients, when performed by experienced surgeons.Trial registration: ClinicalTrials.gov Identifier: NCT01480128.