Postoperative renal morbidity and mortality after volume replacement with hydroxyethyl starch 130/0.4 or albumin during surgery: a propensity score-matched study.

PURPOSE: We aimed to compare retrospectively the rates of renal morbidity and mortality in surgical patients receiving 6% HES 130/0.4 to those receiving albumin. METHODS: From a Japanese nationwide medical database between 2014 and 2016, we identified adults who received HES 130/0.4 (HES group) or albumin (albumin group) as a single colloid solution on the day of surgery. After propensity score matching, the two groups were analyzed with χ2 or Mann Whitney U test. The primary outcome was the incidence of acute kidney injury (AKI). Secondary outcomes included the incidence of renal-replacement therapy, hospital length of stay, in-hospital 30-day mortality, the use of vasoactive agents, and the fluid requirement on the day of surgery. RESULTS: Of 76,048 patients in the database, propensity score matching identified 289 matched pairs. There was no statistically significant difference in the incidence of AKI between the HES and the albumin group (15.2% vs. 20.8%, respectively: P = 0.08). The secondary outcomes did not differ between groups except the following. Median hospital stay was 5 days shorter in the HES group (18 vs. 23 days; P < 0.001), and the median net fluid requirement on the day of surgery was 15 mL/kg lower in the HES group (140 vs. 155 mL/kg, respectively; P = 0.01). CONCLUSIONS: Postoperative renal morbidity and mortality did not differ between patients receiving HES 130/0.4 and those receiving albumin. HES 130/0.4 was associated with shorter hospital stay and less fluid requirement compared to albumin. These findings support the use of 6% HES 130/0.4 for perioperative volume replacement as an alternative to albumin. TRIAL REGISTRATION: UMIN000027896 and the date of registration was June 30, 2017 at https://www.umin.ac.jp/ctr/index-j.html .

Renal Morbidity of 6% Hydroxyethyl Starch 130/0.4 in 9000 Propensity Score Matched Pairs of Surgical Patients.

BACKGROUND: Several studies of critically ill patients reported that fluid resuscitation with hydroxyethyl starch (HES) solutions damages the kidneys, but their use for surgical patients is debated. Because different HES preparations have different safety profiles, we sought to determine whether 6% third-generation HES 130/0.4 was associated with renal morbidity when used for surgical patients. METHODS: We identified adults enrolled in a Japanese nationwide medical database who underwent surgery between 2014 and 2016, with HES 130/0.4 or without it (controls). These groups were balanced with propensity score matching in a 1:1 ratio without replacement by multivariable logistic regression with 36 covariates, including demographic characteristics, preoperative comorbidities, and anesthetic/surgical procedures. The primary outcome was the incidence of acute kidney injury (AKI) in patients receiving intraoperative HES and controls. Secondary outcomes were assessing whether HES was associated with worsening AKI stage, the incidence of renal-replacement therapy (RRT), hospital length-of-stay, and in-hospital 30-day mortality. Tertiary outcomes include the use of vasoactive agents and the fluid requirement on the day of surgery. Comparative analysis was made with χ, Mann-Whitney U test, or the ordinal logistic regression analysis. RESULTS: Of 76,048 patients in the database, 58,425 were eligible: 9542 received HES and 48,883 controls. Propensity score matching identified 8823 matched pairs. The incidence of AKI was 6.2% (548/8823) in the HES group and 5.6% (492/8823) in controls (odds ratio [OR], 1.12; 95% confidence interval [CI], 0.99-1.27; P = .07). Compared to controls, HES was not associated with worsening AKI stage (OR, 0.89; 95% CI, 0.79-1.01; P = .08). The incidence of RRT was lower in the HES group than that in controls (0.2% vs 0.4%, respectively; OR, 0.51; 95% CI, 0.29-0.91; P = .02). Median [interquartile range] hospital stay was 1 day longer in the HES group (12 [8-21] vs 11 [7-20] days; P < .001), but in-hospital 30-day mortality did not differ between groups (0.5% vs 0.6%, respectively: OR, 0.83; 95% CI, 0.56-1.24; P = .36). The use rate of vasoactive agents and the median net fluid requirement on the day of surgery were higher in the HES group (80.5% vs 70.0%: P < .001, 88.1 vs 73.6 mL/kg; P < .001, respectively) compared to controls. CONCLUSIONS: The present study did not demonstrate that 6% HES 130/0.4 increased the incidence and the severity of postoperative AKI. It was associated with a lower incidence of RRT when used for surgical patients.

Blood transfusion, colloid therapy and the possible saving of albumin volumes during surgery: data analysis of the survey for certified hospitals of the Japanese Society of Anesthesiologists.

PURPOSE: Third-generation hydroxyethyl starch (HES) 130/0.4 has a larger dose limitation (up to 50 mL/kg/day) than HES 70/0.5 (up to 1000 mL/day) which has been used in Japan for 40 years. The aim of this study was to survey the current intraoperative blood transfusion and volume therapy and to predict the possible reduction of intraoperative albumin consumption assuming further replacement by HES 130/0.4 using data obtained from a survey by the Japanese Society of Anesthesiologists (JSA), although HES130/0.4 was not launched in Japan during this survey period. METHODS: In a JSA survey conducted at JSA-certified hospitals, 12,856 patients with a certain amount of blood loss were analyzed for 1 month (April, 2012). The patients were divided into two groups-group A included patients aged ≥11 years and group B included patients aged <10 years. The possible lower volume of intraoperative albumin was calculated assuming that HES 130/0.4 was used up to a dose of 50 mL/kg. RESULTS: Blood loss (total 15,111 L; 15,057 L in group A and 54 L in group B) was treated with allogeneic transfusion (total 7970 L; 7893 L in group A and 77 L in group B) and auto-transfusion (total 1777 L; 1771 L in group A and 6 L in group B) in both groups (n = 11,670 and 119). Albumin (total 1391 L; 1376 L in group A and 15 L in group B), and HES 70/0.5 (total 7645 L; 7638 L in group A and 7 L in group B) were used in both groups (n = 10,850 and 116). Five percent and 4.4 % albumin (total 1189 L; 1180 L in group A and 9 L in group B) could be replaced by HES 130/0.4 if HES 130/0.4 had been used up to a dose of 50 mL/kg. CONCLUSION: Blood loss (15,111 L) was replaced with allogeneic transfusion (53 %), auto-transfusion (12 %), albumin (9 %) and HES 70/0.5 (51 %) during surgery in April 2012. The predicted volume of 5 and 4.4 % albumin saved during this 1-month period if HES 130/0.4 had been used up to a dose of 50 mL/kg was 1189 L (86 % of actual amount used).

Pharmacokinetics and safety of 6 % hydroxyethyl starch 130/0.4 in healthy male volunteers of Japanese ethnicity after single infusion of 500 ml solution.

PURPOSE: This phase I study was performed in volunteers of Japanese ethnicity to compare pharmacokinetic data after infusion of 6 % hydroxyethyl starch (HES) 130/0.4 with historical data of Caucasians. METHODS: In an open-label, uncontrolled, single-center study, 12 healthy male Japanese volunteers received single intravenous infusions of 500 ml 6 % HES 130/0.4 (Voluven 6 %; Fresenius Kabi Deutschland, Bad Homburg, Germany) over 30 min. RESULTS: Plasma concentration of 6 % HES 130/0.4 was highest at end of infusion (5.53 ± 0.55 mg/ml) and decreased following a biphasic manner. Total plasma clearance and rapid and slow elimination half-lives obtained by a two-compartment model were 1.14 ± 0.16 l/h, 1.12 ± 0.26 h, and 9.98 ± 2.38 h, respectively, and the volume of distribution was 4.76 ± 0.64 l. Mean area under the concentration-time curve was 26.7 ± 3.75 mg/ml h. The total amount of HES excreted into urine was 59.4 % of the applied dose. Hemodilution was observed in all 12 subjects as indicated by a decrease of hemoglobin from 15.5 ± 0.4 g/dl at baseline to 13.8 ± 0.4 g/dl after the end of infusion. Adverse events in this study refer to changes of laboratory parameters and were assessed as not clinically relevant. CONCLUSION: Single administration of a 500 ml solution of 6 % HES 130/0.4 was confirmed to be safe and tolerable in healthy male Japanese subjects. A rapid renal excretion was observed within 24 h after drug administration, accounting for 96 % of the total amount excreted. A comparison with pharmacokinetic data derived from Caucasians did not reveal significant differences to Japanese and confirmed the good tolerability in both ethnic groups.

Safety and efficacy of oral rehydration therapy until 2 h before surgery: a multicenter randomized controlled trial.

PURPOSE: In many countries, patients are generally allowed to have clear fluids until 2-3 h before surgery. In Japan, long preoperative fasting is still common practice. To shorten the preoperative fasting period in Japan, we tested the safety and efficacy of oral rehydration therapy until 2 h before surgery. METHODS: Three hundred low-risk patients scheduled for morning surgery in six university-affiliated hospitals were randomly assigned to an oral rehydration solution (ORS) group or to a fasting group. Patients in the ORS group consumed up to 1,000 ml of ORS containing balanced glucose and electrolytes: 500 ml between 2100 the night before surgery and the time they woke up the next morning and 500 ml during the morning of surgery until 2 h before surgery. Patients in the fasting group started fasting at 2100 the night before surgery. Primary endpoints were gastric fluid volume and pH immediately after anesthesia induction. Several physiological measures of hydration and electrolytes including the fractional excretion of sodium (FENa) and the fractional excretion of urea nitrogen (FEUN) were also evaluated. RESULTS: Mean (SD) gastric fluid volume immediately after anesthesia induction was 15.1 (14.0) ml in the ORS group and 17.5 (23.2) ml in the fasting group (P = 0.30). The mean difference between the ORS group and fasting group was -2.5 ml. The 95% confidence interval ranged from -7.1 to +2.2 ml and did not include the noninferior limit of +8 ml. Mean (SD) gastric fluid pH was 2.1 (1.9) in the ORS group and 2.2 (2.0) in the fasting group (P = 0.59). In the ORS group, mean FENa and FEUN immediately after anesthesia induction were both significantly greater than those in the fasting group (P < 0.001 for both variables). The ORS group reported they had been less thirsty and hungry before surgery (P < 0.001, 0.01). CONCLUSIONS: Oral rehydration therapy until 2 h before surgery is safe and feasible in the low-risk Japanese surgical population. Physicians are encouraged to use this practice to maintain the amount of water in the body and electrolytes and to improve the patient's comfort.

[Use of StyletScope in a patient with airway injury].

A forty-year old man hanged himself and was transported to our hospital. On arrival his consciousness was clear but he showed dyspnea, dysphagia, and oral bleeding. Tracheal intubation was attempted but was failed and emergency tracheostomy was successfully accomplished. Tracheoplasty was soon scheduled under general anesthesia because of subcutaneous emphysema. An ordinary laryngoscope could not give a view of the larynx at all. Orotracheal intubation was accomplished with StyletScope. It worked very well for the destroyed trachea. StyletScope is a useful device for intubation, especially in difficult airway management.

Fluid therapy with hydroxyethyl starch for massive blood loss during surgery.

PURPOSE: This clinical trial reports the use of hydroxyethyl starch (HES70/0.55/4) at very high dosages during surgery. HES70/0.55/4 has the lowest molecular weight among all HES products, and thus may have the least side effects. This observational retrospective study clarified the effects of high-dose HES70/0.55/4 on coagulation and renal function up to 1 month after massive bleeding during surgery. METHODS: Of 20875 patients on our surgical database, 31 patients were identified who had lost more than 5000 ml of blood during surgery and had survived for more than 1 month. The fluid balance, and pre- and postoperative laboratory data were analyzed. Patients were assessed using acute kidney injury (AKI) criteria. AKI and non-AKI groups were compared regarding volume of HES70/0.55/4 infused and serum creatinine (Cr) levels before surgery and until 1 month after surgery. RESULTS: The mean volumes of blood loss, total transfusions, HES70/0.55/4, and urine output during surgery were 8051 ml; 5765 ml; 3085 ml (54 ml/kg); and 1338 ml (2.7 ml/kg/h), respectively. Cr increased, and activated partial thromboplastin time, prothrombin time and international normalized ratio were prolonged postoperatively (0.77-0.9 mg/dl, 34-52 s, and 1.1-1.7, respectively). Of the 31 patients, 13 developed AKI, and 10 of the 13 had recovered at 1 month. Renal impairment due to HES70/0.55/4 was not evident, as shown by the finding that the HES70/0.55/4 amount infused in the AKI patients (53 ml/kg) did not differ from that in the nonAKI patients (55 ml/kg), and there was no relationship between the amount of HES infused and Cr changes. CONCLUSION: High-dose HES70/0.55/4 could be safely used in massive bleeding during surgery. HES70/0.55/4 may affect coagulation, but renal impairment was not evident 1 month after surgery.

[Effect of the music-therapy under spinal anesthesia].

BACKGROUND: Since no pre-medication has been widely accepted especially in spinal anesthesia, anesthesiologists should manage the control of patient's anxiety during surgery. Instead of sedatives, we have been using music-therapy during spinal anesthesia. Bispectral index monitoring (BIS) is used as one of the sedation indices in spinal anesthesia. The aim of this study was to assess the music-therapy on reducing anxiety of patients under spinal anesthesia using BIS and interview type psychology test, State Trait Anxiety Inventory (STAI). METHODS: Fifty-eight ASA physical status I-II patients scheduled for spinal anesthesia, were randomly allocated into M group (music group, n=29) or C group (control, n=29). BIS, EMG, and SQI of both groups were obtained continuously with computer system. Patients in M group listened to music by head phone and those in C group were left free under ordinary operating theater environment. Trait Anxiety Inventory (STAI-TA) score was obtained preoperatively for property-based anxiety and the State Anxiety Inventory (STAI-SA) score was obtained postoperatively for condition-based anxiety. Time averaged BIS scores (pre-surgery, during-surgery and post-surgery period)were obtained during operation. RESULTS: Time averaged BIS values of M and C group in pre-surgery period, during-surgery period, and post-surgery period were 95.3+/-0.4 vs 95.8+/-0.4 (NS), 87.6+/-7.5 vs 95.1+/-2.8 (P<0.01) and 96.0+/-0.4 vs. 96.2+/-0.4 (NS), respectively. Post-surgery STAI-SA was 29.7+/-7.2 in M group vs 38.8+/-10.3 in C group (P<0.01) while pre-surgery STAI-SA scores of both groups were not different. CONCLUSIONS: Music-therapy reduced BIS value and was effective to reduce patient's anxiety during spinal anesthesia.

[Anesthetic management for cases of placenta accreta presented for cesarean section: a 7-year single-center experience].

BACKGROUND: Anesthetic management of cesarean section for placenta accreta is very challenging. The aim of our retrospective study was to review past placenta accreta cases in our hospital to suggest a strategy for anesthetic management for placenta accreta. METHODS: Placenta accreta cases were identified in our obstetric anesthesia data base. Their diagnosis, surgical procedure, amount of blood loss and anesthetic management were reviewed. RESULTS: Twenty-two cases of placenta accreta were identified. Of them 16 cases underwent cesarean hysterectomy. The amount of blood loss in the 22 cases ranged from 590 to 10500 ml. Neuraxial anesthesia alone was planned in 11 cases, 6 of which were converted to general anesthesia due to massive bleeding. In most of the cases, more than 2 large-bore intravenous lines and arterial line were placed prior to the beginning of surgery. All cases were well managed. CONCLUSIONS: We suggest the minimum requirements for anesthetic management in patients with placenta accreta as follows: (1) discussion with obstetricians to formulate a cesarean section plan, (2) early evaluation to formulate an anesthetic plan and to obtain informed consent, (3) two experienced anesthesiologists, (4) general anesthesia, (5) 2 large-bore intravenous lines, (6) an arterial line and (7) 10 units of both fresh frozen plasma and crossmatched packed red blood cells.

Gender differences between predicted and measured propofol C(P50) for loss of consciousness.

OBJECTIVE: To investigate gender differences in the effective dose of 50% for loss of consciousness (C(P50LOC)) for propofol using Diprifusor, the most commonly used target-controlled infusion system. DESIGN: Prospective, randomized, comparative study. SETTING: University-affiliated hospital. PATIENTS: 50 ASA physical status I and II patients, aged 20 to 50 years, scheduled for minor surgery. INTERVENTIONS: Patients were randomized into two groups of 25 patients each. A target-controlled infusion of propofol (Diprifusor) was maintained at a predetermined target concentration. After a 10-minute steady state, blinded investigators evaluated patients' consciousness using verbal commands. The propofol test concentration was predetermined using a modified version of Dixon's up-and-down method (starting at 2.5 mug/mL; step size of 0.1 microg/mL). MEASUREMENT: Predicted and measured C(P50LOC) values and bispectral index (BIS) were obtained by averaging the crossover midpoint (ie, consciousness to unconsciousness). Those values were analyzed by unpaired t test: P < 0.05 was considered significant. RESULTS: The predicted C(P50LOC) for men was 2.14 +/- 0.10 microg/mL, which was lower than that for women, 2.55 +/- 0.11 microg/mL (P < 0.0001). No significant difference was found for measured C(P50LOC) in men (2.37 +/- 0.41 microg/mL) and in women (2.30 +/- 0.28 microg/mL) or for BIS measurements. CONCLUSION: Predicted C(P50LOC) by Diprifusor for men tended to be underestimated; that for women tended to be overestimated. Our data support a review of Diprifusor (Astra Zeneca, Osaka, Japan) pharmacokinetic parameters to avoid awareness during operation, particularly for women.

[Newly developed BONFILS Retromolar Intubation Fiberscope for difficult airway].

Battery powered BONFILS Retromolar Intubation Fiberscope (BRIF) is a nonflexible fiberscope having the same curvature as the Macintosh laryngoscope for difficult airway. We used this device in two patients; A 65-year-old man with small chin and a 35-year-old man with neck spinal cord injury. Two trials of orotracheal intubation were accomplished easily in 20 seconds. We conclude that BRIF is useful for orotracheal intubation in patients in whom neck extension is contra-indicated.

Determination of the standard value of circulating blood volume during anesthesia using pulse dye-densitometry: a multicenter study in Japan.

PURPOSE: The standard value for circulating blood volume (BV) during anesthesia was determined by a multicenter study in Japan. The significance of BV on the reduction of blood pressure after the induction of anesthesia was also examined. METHODS: The study included 184 patients from eight university hospitals. After the induction of anesthesia, pulse dye-densitometry was performed according to a uniform protocol. Factors contributing to reduced blood pressure after induction of anesthesia were examined by multiple logistic regression analysis. RESULTS: The mean and standard deviation of BV was 80.0 +/- 13.9 ml x kg(-1); for females and 84.2 +/- 15.3 ml x kg(-1) for males (P > 0.05). There was no age difference in terms of BV. After adjusting for the effects of height, weight, and age, the factors predisposing to a reduction in blood pressure of >20 mmHg after induction of anesthesia were found to be age (P < 0.01) and BV (ml x kg(-1)) (P < 0.001). CONCLUSION: We determined the BV of anesthetized patients before surgery in Japan using pulse dye-densitometry. It is suggested that age is not a factor regarding BV, and that blood pressure tends to be reduced in hypovolemic patients after induction of anesthesia.

[Blood lactate levels during fast-track cardiac anesthesia].

BACKGROUND: Lactate is a very sensitive marker of outcomes in critically ill patients. The aim of this study was to investigate the significance of blood lactate measurement during fast-track cardiac anesthesia. METHODS: We examined arterial blood lactate levels of 12 patients following coronary artery bypass graft surgery under intermittent aortic cross clamping with fast-track cardiac anesthesia. Anesthesia was induced with propofol and fentanyl, and maintained with propofol, fentanyl (total 400-1000 micrograms) and isoflurane. Blood samples were collected from a radical artery catheter. RESULTS: At the termination of the extracorporeal circulation, the blood lactate was 10.3 +/- 2.0 (7.4-12.5) mmol.l-1. This value decreased slowly to 1.5 +/- 0.4 mmol.l-1 on the second postoperative day. All patients were extubated within 4 hours after surgery. Vital signs were stable, and no cardiac events occurred perioperatively. CONCLUSIONS: A continuous decline in blood lactate levels was related to a favorable postoperative course. Further research might be required to prevent transient hyperlactecemia at the end of cardiopulmonary bypass.

[Reduction in the use of pulmonary artery catheter for cardiovascular surgery].

In this study we have surveyed the rate of use of pulmonary artery catheter (PAC) in 319 cardiovascular operations from 1997 to 2001. The rate was decreasing year by year from 100%(6/6) in 1997, 77%(39/51) in '98, 32%(24/75) in '99, 20%(19/93) in 2000, to 8.5%(8/94) in 2001. Especially in elective coronary artery bypass grafting (CABG), an extreme reduction was found: 100%(3/3), 95% (19/20), 17%(6/35), 2.2%(1/45), 0%(0/53), respectively. There was no statistical significance between the use and hospital mortality. We consider that this reduction is due to improvement of the surgical technique and anesthetic management. As transesophageal echocardiography (TEE) has improved anesthetic management of the cardiac patients, we have employed it for all cases. We are sure that TEE contributed to the reduction in the catheter use. Cardiac functions monitored with PAC can be largely substituted with TEE except mixed venous oxygen saturation, but it is not continuous monitoring. Current indications of PAC is for patients with pulmonary hypertension and low cardiac output, as well as those who are predicted to be difficult for postoperative management, and those who have off pump CABG with inverted heart position, at our institution. Routine use of PAC for cardiac surgery should be reconsidered.