The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study.

BACKGROUND: Only a few studies have been reported on the use of dexmedetomidine for sedating surgical patients requiring epidural or spinal anesthesia. We conducted a randomized, double-blind, placebo-controlled, parallel-group study at 12 hospitals in Japan. METHODS: Adult patients were randomly allocated to receive an intravenous administration of placebo or dexmedetomidine at 0.067, 0.25, 0.5 or 1.0 µg/kg over 10 min after epidural or spinal anesthesia. All dexmedetomidine groups received dexmedetomidine 0.2-0.7 µg/kg/h to maintain an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score of ≤ 4; however, propofol was administered to rescue patients who exceeded this score. Surgery was then started 15 min after study drug infusion in patients with OAA/S score of ≤ 4. The primary endpoint was the percentage of patients not requiring rescue propofol to achieve and maintain an OAA/S score of ≤ 4. RESULTS: Of the 120 enrolled and randomized patients, 119 were treated the study: 22 received placebo and 97 received dexmedetomidine (23-25 patients per dose). Significantly more patients did not require propofol in the dexmedetomidine 0.5 and 1.0 µg/kg groups (68.0% and 80.0%, respectively) compared to the placebo group (22.7%) (P = 0.003 and P < 0.001, respectively). Common adverse events (AEs) were protocol-defined respiratory depression, bradycardia and hypotension. There was no significant difference in the incidence of AEs between the dexmedetomidine and the placebo groups. CONCLUSION: We concluded that loading doses of 0.5 and 1.0 µg/kg dexmedetomidine, followed by an infusion at a rate of 0.2-0.7 µg/kg/h, provide effective and well-tolerated sedation for surgical patients during epidural or spinal anesthesia.Clinical trials.gov identifier: NCT01438957.

Real-World Clinical Application of 12-Week Sofosbuvir/Velpatasvir Treatment for Decompensated Cirrhotic Patients with Genotype 1 and 2: A Prospective, Multicenter Study.

INTRODUCTION: Clinical trials of direct-acting antivirals for patients with decompensated cirrhosis have been conducted, but there is limited information on the medicinal applications in clinical settings. We aimed to evaluate the safety and efficacy of sofosbuvir/velpatasvir for decompensated cirrhotic patients with genotypes 1 and 2 in real-world clinical practice. METHODS: A prospective, multicenter study of 12-week sofosbuvir/velpatasvir was conducted for patients with decompensated cirrhosis at 33 institutions. RESULTS: The cohort included 71 patients (52 genotype 1, 19 genotype 2): 7 with Child-Pugh class A, 47 with class B, and 17 with class C (median score 8; range 5-13). The albumin-bilirubin (ALBI) score ranged from - 3.01 to - 0.45 (median - 1.58). Sixty-nine patients (97.2%) completed treatment as scheduled. The overall rate of sustained virologic response at 12 weeks post-treatment (SVR12) was 94.4% (67/71). SVR12 rates in the patients with Child-Pugh classes A, B, and C were 85.7%, 97.9%, and 88.2%, respectively. Among 22 patients with a history of hepatocellular carcinoma treatment, 20 (90.9%) achieved SVR12. The Child-Pugh score and ALBI grade significantly improved after achieving SVR12 (p = 7.19 × 10-4 and 2.42 × 10-4, respectively). Notably, the use of diuretics and branched-chain amino acid preparations significantly reduced after achieving SVR12. Adverse events were observed in 19.7% of the patients, leading to treatment discontinuation in two patients with cholecystitis and esophageal varices rupture, respectively. CONCLUSION: Twelve weeks of sofosbuvir/velpatasvir in real-world clinical practice yielded high SVR rates and acceptable safety profiles in decompensated cirrhotic patients with genotypes 1 and 2. Achievement of SVR not only restored the liver functional reserve but also reduced or spared the administration of drugs for related complications. TRIAL REGISTRATION: UMIN registration no, 000038587.

Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial.

PURPOSE: This trial was conducted to confirm the non-inferiority of remimazolam versus propofol in the induction and maintenance of general anesthesia in surgical patients. METHODS: Surgical patients (n = 375) were randomized to remimazolam started at 6 or 12 mg/kg/h by continuous intravenous (IV) infusion until the loss of consciousness (LoC), followed by 1 mg/kg/h to be adjusted as appropriate until the end of surgery or IV propofol administered as a slow bolus of 2.0-2.5 mg/kg until LoC followed by 4-10 mg/kg/h until the end of surgery. Efficacy was measured via the combined primary endpoint of no intraoperative awakening/recall, no need for rescue sedatives, and no body movements. Adverse events and adverse drug reactions (ADRs) were monitored for safety. RESULTS: Efficacy rates were 100% in all treatment groups, and the non-inferiority of remimazolam was demonstrated [95% confidence interval (- 0.0487; 0.0250)]. The time to LoC was longer in the remimazolam 6 (p < 0.0001) and 12 mg/kg/h (p = 0.0149) groups versus propofol. The time to extubation was longer in both remimazolam groups versus the propofol group (p ≤ 0.0001). The incidence of ADRs was similar in the remimazolam groups (39.3% and 42.7%, respectively) compared with the propofol group (61.3%). Decreased blood pressure occurred in 20.0% and 24.0% of patients treated with 6 and 12 mg/kg/h remimazolam, respectively, compared with 49.3% of patients receiving propofol. Injection site pain was reported in 18.7% of propofol patients but not in those receiving remimazolam. CONCLUSIONS: This trial demonstrated that remimazolam was well tolerated and non-inferior to propofol with regard to efficacy as a sedative hypnotics for general anesthesia. CLINICAL TRIAL REGISTRATION: This trial is registered with the Japan Pharmaceutical Information Center - Clinical Trials Information (JapicCTI). JapicCTI number: 121973.

Isoflurane Induces Transient Impairment of Retention of Spatial Working Memory in Rats.

Postoperative cognitive dysfunction (POCD) occurs in nearly one-third of patients after non-cardiac surgery. Many animal behavior studies have investigated the effect of general anesthesia on cognitive function. However, there have been no studies examining the effects on working memory specifically, with a focus on the retention of working memory. We demonstrate here that isoflurane anesthesia induces deficits in the retention of spatial working memory in rats, as revealed by an increase in isoflurane- induced across-phase errors in the delayed spatial win-shift (SWSh) task with a 30-min delay in an 8-arm radial arm maze on post-anesthesia days (PADs) 1,2,4, and 10. A post-hoc analysis revealed a significant increase in across-phase errors on PAD 1 and recovery on PAD 10 in the isoflurane group. In contrast, within-phase errors independent of the retention of working memory were unaffected by isoflurane. These results demonstrate that isoflurane anesthesia transiently impairs the retention of spatial working memory in rats.

Storage duration of transfused red blood cells is not significantly associated with postoperative adverse events in pediatric cardiac surgery patients.

The aim of this study was to evaluate the association of storage duration of transfused red blood cells with the risk of postoperative serious adverse events in pediatric cardiac surgery patients. We studied 517 patients and found that 22 patients (4.3%) had at least one serious adverse event. The maximum and mean storage duration of transfused red blood cells did not differ significantly between patients with and without serious adverse events (maximum, p = 0.89; mean, p = 0.81). In our study of pediatric cardiac surgery patients, the storage duration of transfused red blood cells was not significantly associated with the risk of serious adverse events.

Urinary Albumin Levels Predict Development of Acute Kidney Injury After Pediatric Cardiac Surgery: A Prospective Observational Study.

OBJECTIVE: Mortality and morbidity of acute kidney injury (AKI) after cardiac surgery still remain high. The authors undertook the present study to evaluate the utility of early postoperative urinary albumin (uAlb) as a diagnostic marker for predicting occurrence of AKI and its severity in pediatric patients undergoing cardiac surgery. DESIGN: A prospective observational study. SETTING: A single-institution university hospital. PARTICIPANTS: All patients<18 years of age who underwent repair of congenital heart disease with cardiopulmonary bypass between July 2010 and July 2012 were included in the study. Neonates age<1 month were excluded from the study population. INTERVENTIONS: The association between uAlb and occurrence of AKI within 3 days after admission to the intensive care unit was investigated. Criteria from pediatric-modified Risk Injury Failure Loss and End-stage kidney disease (pRIFLE) were used to determine the occurrence of AKI. The value of uAlb was measured at intensive care unit admission immediately after cardiac surgery in all participants from whom a 5-mL urine sample was obtained. MEASUREMENTS AND MAIN RESULTS: Of 376 patients, AKI assessed by pRIFLE was identified in 243 (64.6%): 172 for risk (R; 45.7%), 44 for injury (I; 11.7%), and 27 for failure (F; 7.2%). One hundred thirty-three patients (35.4%) were classified as being without AKI (normal [N]) by pRIFLE. The concentration of uAlb was significantly higher in AKI patients than in non-AKI patients (median [interquartile range]): uAlb (µg/mL): 13.5 (6.4-39.6) v 6.0 (3.4-16), p<0.001; uAlb/Cr (mg/gCr): 325 (138-760) v 121 (53-269), p< 0.001. CONCLUSIONS: The utility of uAlb for prompt diagnosis of AKI was shown. Obtaining uAlb measurements early after pediatric cardiac surgery may be useful for predicting the occurrence and severity of AKI.

[Subcutaneous continuous injection of octreotide decreased the tumor marker levels and induced cystic necrosis of the tumors in a case of pancreatic neuroendocrine tumor with multiple hepatic metastases].

For symptom alleviation, subcutaneous continuous injection of octreotide was administered to a patient with pancreatic neuroendocrine tumor (NET) accompanied by multiple hepatic metastases and ascites. The level of the tumor marker neuron-specific enolase decreased to the normal range and cystic necrosis of the tumors was confirmed. There have been some reports on the antineoplastic effects of octreotide on pancreatic NET; therefore, octreotide appears to be a valid option as a therapeutic agent in patients with highly advanced pancreatic NET, in whom administration of molecular targeted or anticancer agents is difficult because of a poor general status.

The association of plasma gamma-aminobutyric acid concentration with postoperative delirium in critically ill patients.

OBJECTIVE: Delirium is a common complication in postoperative, critically ill patients. The mechanism of postoperative delirium is not well understood but many studies have shown significant associations between benzodiazepine use, alcohol withdrawal and cirrhosis, and an increased risk of delirium. We aimed to investigate a possible link with alterations of gamma-aminobutyric acid (GABA) activity. DESIGN, SETTING AND PARTICIPANTS: A prospective observational investigation of 40 patients > 20 years old who had undergone elective surgery with general anaesthesia and were expected to need postoperative intensive care for more than 48 hours. We assessed postoperative delirium using the confusion assessment method in the intensive care unit at 1 hour after the operation and on postoperative Day (POD) 1 and POD 2. We collected blood samples for measurement of plasma GABA concentrations before the operation and on POD 1 and 2. MAIN OUTCOME MEASURES: Postoperative delirium and perioperative plasma GABA concentrations in patients with and without delirium. RESULTS: Postoperative delirium occurred in 13 of the patients. Patients with delirium had significantly higher Acute Physiology and Chronic Health Evaluation II scores than patients without delirium. The mean plasma GABA concentration on POD 2 was significantly lower in patients with delirium than in those without delirium. After adjustment of relevant variables, plasma GABA concentration on POD 2 was independently associated with postoperative delirium. CONCLUSIONS: Plasma GABA level on POD 2 has a significant independent association with postoperative delirium.

[Effect of continuous interscalene block with ropivacaine at a low concentration on postoperative pain relief after arthroscopic rotator cuff reconstruction].

BACKGROUND: The analgesic effect of continuous interscalene block with ropivacaine at a low concentration was compared with that of single-shot interscalene block after arthroscopic rotator cuff reconstruction (ARCR). METHODS: Eighty patients scheduled to undergo ARCR from January 2010 to March 2012 were assigned to a group receiving postoperative continuous interscalene block (continuous group, n=46) and a group receiving single-shot interscalne block (single group, n=34). In both groups, ultrasound-guided interscalene block was performed before induction of general anesthesia. In the Continuous group, continuous interscalene infusion with 0.1% ropivacaine was performed up to postoperative 48 hours. Pain intensity (Prince-Henry scale), additional use of analgesics, and adverse effects were recorded. Statistical analysis was performed with Mann-Whitney test, and P<0.05 was considered to be significant. RESULTS: Pain intensity in the continuous group was significantly lower than that in the single group on the night of the day of operation and the morning of the first postoperative day. The frequency of use of additional analgesic in the continuous group was approximately half of that in the single group. No complete motor block was recorded during continuous infusion of ropivacaine. CONCLUSIONS: Postoperative continuous interscalene block with 0.1% ropivacaine provided sufficient analgesia without complete motor block.

[An autopsy of G-CSF-producing anaplastic carcinoma of the pancreas with impaired accumulation on FDG-PET after S-1 chemotherapy].

This paper presents a woman in her 70's with G-CSF producing anaplastic carcinoma of the pancreas(Stage IVb)who underwent chemotherapy by S-1 alone. On FDG-PET after the first course, accumulation of FDG was impaired remarkably. After the second course, the patient died of carcinomatous pleuritis and peritonitis on the 88th day after initiation of treatment. G-CSF producing anaplastic carcinoma of the pancreas is extremely rare and there are no reports with regard to response evaluation by FDG-PET. Thus, this case has significant clinical value.

Effects of biliverdin administration on acute lung injury induced by hemorrhagic shock and resuscitation in rats.

Hemorrhagic shock and resuscitation induces pulmonary inflammation that leads to acute lung injury. Biliverdin, a metabolite of heme catabolism, has been shown to have potent cytoprotective, anti-inflammatory, and anti-oxidant effects. This study aimed to examine the effects of intravenous biliverdin administration on lung injury induced by hemorrhagic shock and resuscitation in rats. Biliverdin or vehicle was administered to the rats 1 h before sham or hemorrhagic shock-inducing surgery. The sham-operated rats underwent all surgical procedures except bleeding. To induce hemorrhagic shock, rats were bled to achieve a mean arterial pressure of 30 mmHg that was maintained for 60 min, followed by resuscitation with shed blood. Histopathological changes in the lungs were evaluated by histopathological scoring analysis. Inflammatory gene expression was determined by Northern blot analysis, and oxidative DNA damage was assessed by measuring 8-hydroxy-2' deoxyguanosine levels in the lungs. Hemorrhagic shock and resuscitation resulted in prominent histopathological damage, including congestion, edema, cellular infiltration, and hemorrhage. Biliverdin administration prior to hemorrhagic shock and resuscitation significantly ameliorated these lung injuries as judged by histopathological improvement. After hemorrhagic shock and resuscitation, inflammatory gene expression of tumor necrosis factor-α and inducible nitric oxide synthase were increased by 18- and 8-fold, respectively. Inflammatory gene expression significantly decreased when biliverdin was administered prior to hemorrhagic shock and resuscitation. Moreover, after hemorrhagic shock and resuscitation, lung 8-hydroxy-2' deoxyguanosine levels in mitochondrial DNA expressed in the pulmonary interstitium increased by 1.5-fold. Biliverdin administration prior to hemorrhagic shock and resuscitation decreased mitochondrial 8-hydroxy-2' deoxyguanosine levels to almost the same level as that in the control animals. We also confirmed that biliverdin administration after hemorrhagic shock and resuscitation had protective effects on lung injury. Our findings suggest that biliverdin has a protective role, at least in part, against hemorrhagic shock and resuscitation-induced lung injury through anti-inflammatory and anti-oxidant mechanisms.

Low serum concentrations of vitamin B6 and iron are related to panic attack and hyperventilation attack.

Patients undergoing a panic attack (PA) or a hyperventilation attack (HVA) are sometimes admitted to emergency departments (EDs). Reduced serotonin level is known as one of the causes of PA and HVA. Serotonin is synthesized from tryptophan. For the synthesis of serotonin, vitamin B6 (Vit B6) and iron play important roles as cofactors. To clarify the pathophysiology of PA and HVA, we investigated the serum levels of vitamins B2, B6, and B12 and iron in patients with PA or HVA attending an ED. We measured each parameter in 21 PA or HVA patients and compared the values with those from 20 volunteers. We found that both Vit B6 and iron levels were significantly lower in the PA/HVA group than in the volunteer group. There was no significant difference in the serum levels of vitamins B2 or B12. These results suggest that low serum concentrations of Vit B6 and iron are involved in PA and HVA. Further studies are needed to clarify the mechanisms involved in such differences.

Accuracy of blood-glucose measurements using glucose meters and arterial blood gas analyzers in critically ill adult patients: systematic review.

INTRODUCTION: Glucose control to prevent both hyperglycemia and hypoglycemia is important in an intensive care unit. Arterial blood gas analyzers and glucose meters are commonly used to measure blood-glucose concentration in an intensive care unit; however, their accuracies are still unclear. METHODS: We performed a systematic literature search (January 1, 2001, to August 31, 2012) to find clinical studies comparing blood-glucose values measured with glucose meters and/or arterial blood gas analyzers with those simultaneously measured with a central laboratory machine in critically ill adult patients. RESULTS: We reviewed 879 articles and found 21 studies in which the accuracy of blood-glucose monitoring by arterial blood gas analyzers and/or glucometers by using central laboratory methods as references was assessed in critically ill adult patients. Of those 21 studies, 11 studies in which International Organization for Standardization criteria, error-grid method, or percentage of values within 20% of the error of a reference were used were selected for evaluation. The accuracy of blood-glucose measurements by arterial blood gas analyzers and glucose meters by using arterial blood was significantly higher than that of measurements with glucose meters by using capillary blood (odds ratios for error: 0.04, P<0.001; and 0.36, P<0.001). The accuracy of blood-glucose measurements with arterial blood gas analyzers tended to be higher than that of measurements with glucose meters by using arterial blood (P=0.20). In the hypoglycemic range (defined as <81 mg/dl), the incidence of errors using these devices was higher than that in the nonhypoglycemic range (odds ratios for error: arterial blood gas analyzers, 1.86, P=0.15; glucose meters with capillary blood, 1.84, P=0.03; glucose meters with arterial blood, 2.33, P=0.02). Unstable hemodynamics (edema and use of a vasopressor) and use of insulin were associated with increased error of blood glucose monitoring with glucose meters. CONCLUSIONS: Our literature review showed that the accuracy of blood-glucose measurements with arterial blood gas analyzers was significantly higher than that of measurements with glucose meters by using capillary blood and tended to be higher than that of measurements with glucose meters by using arterial blood. These results should be interpreted with caution because of the large variation of accuracy among devices. Because blood-glucose monitoring was less accurate within or near the hypoglycemic range, especially in patients with unstable hemodynamics or receiving insulin infusion, we should be aware that current blood glucose-monitoring technology has not reached a high enough degree of accuracy and reliability to lead to appropriate glucose control in critically ill patients.

Spinal nerve injury causes upregulation of ErbB2 and ErbB3 receptors in rat dorsal root ganglia.

It is generally known that peripheral nerve injury causes changes in expression of some growth factors in the dorsal root ganglion. Altered expression of ErbB receptors, a well-known growth factor in somatic cells, reportedly follows peripheral nerve injury in the spinal dorsal horn; however, it remains unknown whether the expression of these receptors is altered in the dorsal root ganglion after nerve injury. Therefore, this study examined the gene expression profiles of ErbB receptors in bilateral lumbar (L)4/L5 dorsal root ganglia, using L5-selective spinal nerve ligation in model rats as a peripheral nerve injury model. The expression of ErbB2 and ErbB3 was observed in the dorsal root ganglia of the mature rat, despite ErbB1 and ErbB4 showing only subtle expression. We also demonstrated that peripheral nerve injury induced significant increases in ErbB2 and ErbB3 in the ipsilateral dorsal root ganglion as compared with uninjured nerve. Expression changes in ErbB receptors appear to play important roles in nerve injury and subsequent nerve regeneration.

Inhalation of carbon monoxide following resuscitation ameliorates hemorrhagic shock-induced lung injury.

Even after successful resuscitation, hemorrhagic shock frequently causes pulmonary inflammation that induces acute lung injury (ALI). We previously demonstrated that when CO is inhaled at a low concentration both prior to and following hemorrhagic shock and resuscitation (HSR) it ameliorates HSR-induced ALI in rats due to its anti-inflammatory effects. In the present study, we administered CO to the same model of ALI only after resuscitation and examined whether it exerted a therapeutic effect without adverse events on HSR-induced ALI, since treatment of animals with CO prior to HSR did not prevent lung injury. HSR were induced by bleeding animals to achieve a mean arterial pressure of 30 mmHg for 1 h followed by resuscitation with the removed blood. HSR resulted in the upregulation of inflammatory gene expression and increased the rate of apoptotic cell death in the lungs. This was determined from an observed increase in the number of cells positive for transferase-mediated dUTP-fluorescein isothiocyanate (FITC), nick-end labeling staining and activated caspase-3. HSR also resulted in prominent histopathological damage, including congestion, edema, cellular infiltration and hemorrhage. By contrast, CO inhalation for 3 h following resuscitation significantly ameliorated these inflammatory events, demonstrated by reduced histological damage, inflammatory mediators and apoptotic cell death. The protective effects of CO against lung injury were notably associated with an increase in the protein expression level of peroxisome proliferator-activated receptor (PPAR)-γ, an anti-inflammatory transcriptional regulator in the lung. Moreover, CO inhalation did not affect the hemodynamic status or tissue oxygenation during HSR. These findings suggest that inhalation of CO at a low concentration exerts a potent therapeutic effect against HSR-induced ALI and attenuates the inflammatory cascade by increasing PPAR-γ protein expression.

[Pacing lead extraction using an excimer laser sheath under general anesthesia].

An excimer laser sheath has recently been used for extraction of pacing and ICD leads. By using this technique, leads are removed more easily and it has to take a shorter time to extract leads. Although lead extraction with this method can cause fatal complications such as large vessel injury, little has been reported regarding anesthetic management during the lead extraction. We experienced two cases of pacing lead extraction using an excimer laser sheath under general anesthesia. The procedures were mainly performed by cardiologists in the operating theater. A wide area was prepared with sterile drapes as for cardiac surgery with cardiovascular surgeons standing by. Vascular access catheters were placed in the right femoral artery as well as vein, and in the right internal jugular vein so that immediate PCPS introduction could be performed in case of sudden hemodynamic collapse by massive bleeding. In the first case, lead extraction was completed without any complication, but in the second case sternotomy was performed by cardiac surgeons for safe separation of leads from vessels. There were also no bleeding episodes in the second case. Preparation for bleeding and cooperation among cardiologists, cardiovascular surgeons, medical engineers and anesthesiologists are necessary from the safety point of view of this procedure under general anesthesia.

[A case of successful treatment of granulocyte colony-stimulating factor producing hepatocellular carcinoma accompanying type B hepatitis with tegafur-uracil].

A 37-year-old man underwent lobectomy of the right liver for granulocyte colony-stimulating factor (G-CSF) producing hepatocellular carcinoma accompanying type B hepatitis. Within two months after the surgery, lung metastases were revealed and administration of sorafenib was begun, however, the lung metastases continued to enlarge. Changing the patient's medication to tegafur-uracil provided remarkable reduction of the lung metastases. The patient is alive two years after diagnosis and receives outpatient chemotherapy. We concluded that this case is valuable with regard to the extreme rarity of G-CSF producing hepatocellular carcinoma and its successful treatment in this case.

Antinociceptive effects of intrathecal landiolol injection in a rat formalin pain model.

Perioperative beta-blocker administration has recently been recommended for patients undergoing cardiac or other surgery due to the beneficial cardiovascular effects of these agents. In addition, some studies have reported that perioperatively administered beta-blockers also have analgesic effects. In this study, to investigate the antinociceptive effects and the analgesic profile of landiolol, we examined the effects of intrathecal landiolol administration on nociceptive pain behavior and c-fos mRNA expression (a neural marker of pain) in the spinal cord using a rat formalin model. We found that pain-related behavior was inhibited by intrathecal landiolol administration. Moreover, the increase in c-fos mRNA expression on the formalin-injected side was less pronounced in rats administered landiolol than in saline administered controls. Thus, intrathecal administration of landiolol exhibited antinociceptive effects. Further investigation of the antinociceptive mechanism of landiolol is required.

Effect of tranexamic acid on blood loss in pediatric cardiac surgery: a randomized trial.

PURPOSE: The benefit of tranexamic acid (TXA) in pediatric cardiac surgery on postoperative bleeding has varied among studies. It is also unclear whether the effects of TXA differ between cyanotic patients and acyanotic patients. The aim of this study was to test the benefit of TXA in pediatric cardiac surgery in a well-balanced study population of cyanotic and acyanotic patients. METHODS: A total of 160 pediatric patients undergoing cardiac surgery with cardiopulmonary bypass (81 cyanotic, 79 acyanotic) were included in this single-blinded, randomized trial at a tertiary care university-affiliated teaching hospital. Eighty-one children (41 cyanotic, 40 acyanotic) were randomly assigned to a TXA group, in which they received 50 mg/kg of TXA as a bolus followed by 15 mg/kg/h infusion and another 50 mg/kg into the bypass circuit. The other 79 patients were randomly assigned to a placebo group. The primary end point was the amount of 24-h blood loss. RESULTS: The amount of 24-h blood loss was significantly less in the TXA group than in the placebo group [mean (95% confidence interval): 18.6 (15.8-21.4) vs. 23.5 (19.4-27.5) ml/kg, respectively; mean difference -4.9 (-9.7 to -0.01) ml/kg; p = 0.049]. This effect of TXA was already significant at 6 h [9.5 (7.5-11.5) vs. 13.2 (10.6-15.9) ml/kg, respectively; mean difference -3.47 (-7.0 to -0.4) ml/kg; p = 0.027]. However, there was no significant difference in the amount of blood transfusion between the groups. There was also no statistical difference in the effect of TXA in each cyanotic and acyanotic subgroup. CONCLUSION: TXA can reduce blood loss in pediatric cardiac surgery but not the transfusion requirement (http://ClinicalTrials.gov number NCT00994994).

[Effect of single-shot interscalene block with less than 10 ml of local anesthetics on postoperative pain relief after arthroscopic rotator cuff reconstruction].

BACKGROUND: The effect of interscalene block on postoperative pain after arthroscopic rotator cuff reconstruction (ARCR) was evaluated. METHODS: Eighty-four patients scheduled to undergo ARCR from April 2008 to March 2010 were assigned to a group receiving interscalene block with general anesthesia (Block group, n = 49) and a group receiving general anesthesia solely (General group, n = 35). In the Block group, ultrasound-guided single-shot interscalene block was performed before induction of general anesthesia with 0.375% ropivacaine 7-10ml. Postoperative pain intensity was recorded for 96 hours after the operation. Statistical analysis was performed with Mann-Whitney's U-test, and P < 0.05 was considered to be significant. RESULTS: Numerous rating scale (NRS) in the Block group was significantly lower than that in the General group immediately after the operation (median value: Block group = 0, General group = 6). Duration from the end of operation to the first administration of additional analgesics in the Block group (7 hours) was significantly longer than that in the General group (1 hour). NRS in the Block group tended to be higher than that in the General group from the night of the day of operation. CONCLUSIONS: Single-shot interscalene block with less than 10 ml of ropivacaine before ARCR reduced postoperative pain only for several hours after the operation.