Lower Rates Of Nausea Research Articles

Risk factors for Helicobacter pylori infection in children with gastrointestinal symptoms in Vietnam

ObjectivesTo investigate the prevalence and risk factors associated with Helicobacter pylori infection in Vietnamese children. MethodsChildren under 16 years old with gastrointestinal symptoms underwent esophagogastroduodenoscopy and H. pylori infection was diagnosed using rapid urease test. ResultsA total of 246 children with gastrointestinal symptoms were included. The mean age was 8.4 ± 2.6 years. A total 81.3% tested positive for H. pylori. Children infected with H. pylori had a lower rate of nausea but a higher rate of lesions in the duodenal bulb and nodular lesions than children without H. pylori infection (26.5% vs 45.6%, P <0.01; 40.0% vs 23.9%; P = 0.04; and 68.5% vs 30.3%, P <0.0001, respectively). Compared with children aged under 5 years, children aged 11 years and older were four times more likely to be infected with H. pylori, with odds ratio (OR) 3.50, 95% confidence interval (CI) 1.07-11.39, P = 0.04. Washing hands with soap was associated with a reduced risk of H. pylori infection by three times (OR 0.35, 95% CI 0.17-0.69, P = 0.002). Children living in a family where members had a history of H. pylori infection were nine times more likely to be infected with H. pylori (OR 8.87, 95% CI 1.15-68.45, P = 0.04). ConclusionsThe prevalence of H. pylori infection in Vietnamese children with gastroenteritis is high. Our results identified several risk factors and emphasize the role of handwashing with soap before eating and after using the toilet in reducing the risk of H. pylori infection in children.

The effect of dexamethasone and bupivacaine on postoperative pain and nausea and vomiting by preperitoneal nerve blocking in laparoscopic cholecystectomy: a randomized clinical trial

Background: This study aims to examine the effects of preperitoneal administration of dexamethasone and bupivacaine surrounding laparoscopic trocars on postoperative pain (POP) and nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy (LC). Method: In this randomized triple-blinded trial with a 1:1 randomization ratio, 104 patients with chronic cholecystitis were candidates for elective LC. A total of 40 mg (8 ml) of bupivacaine was mixed with 8 mg (2 ml) of dexamethasone or normal saline. The solution was injected preperitoneally via an 18G needle parallel and lateral to trocars until a bulge in the interior surface of the parietal peritoneum was observed by the camera. Primary outcomes were severity of POP based on 0-10 Likert visual analog scale (VAS) and rates of PONV and secondary outcomes were rate of postoperative opioid usage and any side-effects. Result: The mean VAS score was significantly lower in the dexamethasone group (3.5 vs. 6.2, P&lt;0.001). The dexamethasone group had 46.2% and 26.9% lower rate of nausea and vomiting after LC compared to the other group (P=0.001 and 0.015, respectively). Postoperative opioid use was lower in the dexamethasone group, but its difference was insignificant (P=0.3). Conclusions: Preperitoneal dexamethasone injection around laparoscopic trocars may lower the intensity of POP and PONV rates. Perioperative local corticosteroids can be used as an effective, available, and inexpensive analgesic and antiemetic prevention for laparoscopic procedures.

Comparison of analgesic efficacy between erector spine plane block and intravenous patient-controlled analgesia with morphin after open heart surgery

Pain after cardiac surgery is always an obsession of patients and a top concern of anesthesiologists. Experimental subjects challenged by acute pain and patients in chronic pain experience impairments in attention control, working memory, mental flexibility, problem solving, and information processing speed. The two most commonly used analgesia methods are patient-controlled analgesia (PCA) and erector spinea plane block (ESP). Our study aimed to compare the analgesic effect of ESP with PCA in patients after cardiac surgery using extracorporeal circulation and evaluate the disavantages of these two pain relief techniques. Subject and methods: This study was a randomized controlled intervention study of adult patients who underwent open-heart surgery patients with extracorporeal circulation from May 2020 to September 2021 in the Department of Anesthesiology and Intensive Care Unit - Hanoi Heart Hospital. Results: Two hundred and four (204) consecutive patients were collected, included 108 patients in the ESP group and 96 patients in the PCA group. The mean intraoperative fentanyl amount in the ESP group (0.57±0.50 mg) was lower than in the PCA group (1.00±0.00 mg) (p&lt;0.05). The average VAS score when the patient was lying still and taking deep breaths at the time of assessment in both groups was below 3 (corresponding to low pain level) (p&gt;0.05). The mean morphin consumption 24 hours after surgery was significantly lower in the ESP group (0,23±0,12 mg) than in the PCA group (17,92±3,32 mg) (p&lt;0.05). The mean time after surgery in the ESP group (3.80±1.02 hours) and the PCA group (5.21±1.10 hours) had a clear difference between p&lt;0.05. The mean time of extubation in the ESP group (8.06±1.60 hours) was statistically significantly lower than in the PCA group (8.83±1.43 hours) (p&lt;0.05). The rate of nausea in the ESP group (20.98%) was lower than in the PCA group (58.33%) (p&lt;0.05). Conclusion: Both methods had good analgesic effect with an average VAS score ≤ 3. The ESP group had a lower mean postoperative morphine consumption, a higher patient satisfaction level, and a lower rate of nausea, vomiting, and slow breathing statistically significant less than the PCA group.

Comparison of three neuraxial anesthesia approaches in parturient women with obesity and pregnancy-induced hypertension who underwent cesarean section.

ObjectiveTo compare the effectiveness of different approaches of neuraxial anesthesia in parturient women with obesity and pregnancy-induced hypertension (PIH) who undergo cesarean section (CS).MethodsWe retrospectively analyzed data from 108 parturient women with obesity and PIH who underwent CS. All women were divided into the following three groups according to the neuraxial anesthesia approach: spinal anesthesia (SA), epidural anesthesia (EA), and combined spinal–epidural anesthesia (CSE). Clinical variables were compared.ResultsThe mean age of the patients was 27.3 ± 2.2 years. Women in the CSE group had a longer duration from puncture to surgery, smaller intraoperative change in mean arterial pressure, higher Apgar scores at 1 and 5 minutes, shorter surgery time, lower rates of nausea and vomiting, and lower rate of intraoperative hypotension compared with those in the SA and EA groups.ConclusionCSE takes longer to administer in parturient women with obesity and PIH who undergo CS compared with those who have SA or EA. However, CSE has several advantages over SA or EA, including a shorter surgery time, more stable intraoperative mean arterial pressure, lower rates of nausea, vomiting, and intraoperative hypotension, and better Apgar scores at 1 and 5 minutes.

Efficacy and Safety of Butorphanol Use in Patient-Controlled Analgesia: A Meta-Analysis

Objective This meta-analysis evaluates the efficacy and safety regarding usage of butorphanol in patient-controlled analgesia (PCA). Methods Several databases such as PubMed, Cochrane Library, Embase, CNKI, and VIP were explored with the help of computer search and manual retrieval. Randomized controlled trial (RCT) was selected, and the meta-analysis was conducted using RevMan 5.1. The primary efficacy endpoint was the postoperative visual analog scale score, postoperative Ramsay sedation scale (RSS), and adverse events. Results Nine RCTs met the inclusion criteria and were included in this meta-analysis. No significant differences were found between the butorphanol group and nonbutorphanol group at 12 h and 48 h. The postoperative RSS score at 12 h, 24 h, and 48 h was representative of the calming effect of butorphanol. No significant difference was found on the endpoint of the postoperative RSS score at 12 h, 48 h, and 24 h. The RSS score was lower in the butorphanol group in comparison to the nonbutorphanol group. The butorphanol group was also associated with lower rate of nausea, vomiting, itching, and dizziness compared to the nonbutorphanol group. Conclusion Butorphanol may be used in PCA as a successful postoperative analgesia and is also associated with lower side effects. Further research is needed to verify the efficacy and safety of butorphanol.

Clinical Effect of Different Drugs and Infusion Techniques for Patient-controlled Analgesia After Spinal Tumor Surgery: A Prospective, Randomized, Controlled Clinical Trial

PurposeTo evaluate the outcomes of the different drug combination and infusion techniques for patient-controlled analgesia (PCA). MethodsNinety-seven patients who had undergone spinal tumor surgery were randomized to 4 groups with different PCA drugs and infusion techniques: subcutaneous sufentanil (SS) group; (n=25), subcutaneous sufentanil and dexmedetomidine (SDS) group (n=24), intravenous sufentanil (SI) group (n=23), and intravenous sufentanil and dexmedetomidine (SDI) group (n=25). The primary outcome measured the cumulative amount of sufentanil delivered to the patients through PCA 24 and 48 hours after the surgery. Secondary outcomes measured the visual analog scale pain scores 24 and 48 hours after the surgery, Pittsburgh Sleep Quality Index before and 1 month after surgery, Athens Insomnia Score before and the first 2 nights after surgery, and the rate of adverse events within 48 hours after surgery. FindingsAt 24 and 48 hours after surgery, the cumulative amount of sufentanil in the SDS group (mean [SD], 76.44 [10.75] at 24 hours and 151.96 [20.92] at 48 hours) and the SDI group (mean [SD], 75.08 [9.00] at 24 hours and 149.56 [18.22] at 48 hours) were significantly lower than in SS group (mean [SD] 95.52 [12.40] at 24 hours and 183.23 [23.06] at 48 hours) and the SI group (mean [SD], 97.25 [10.80] at 24 hours and 186.67 [20.14] at 48 hours; P < 0.001). The visual analog scale pain scores and Athens Insomnia Scale scores were also lower in the SDS and SDI groups than in the SS and SI groups 24 and 48 hours after surgery (P < 0.05). The Pittsburgh Sleep Quality Index was lower in the SDS and SDI groups 1 month after surgery. Lastly, the rate of nausea and vomiting was higher in the SI group than in the SS, SDS, and SDI groups (P = 0.018). ImplicationsDexmedetomidine in PCA could decrease sufentanil intake and improve analgesic effect and sleep quality. Subcutaneous PCA can provide the same benefit with a lower rate of nausea and vomiting. ClinicalTrials.gov identifier: NCT04111328.

Opioid-free Anesthesia: Time to Regain Our Balance.

Opioid-free Anesthesia: Time to Regain Our Balance.

Duloxetine for the reduction of opioid use in elective orthopedic surgery: a systematic review and meta-analysis.

Background Duloxetine is currently approved for chronic pain management; however, despite some evidence, its utility in acute, postoperative pain remains unclear Aim of the review This systematic review and meta-analysis is to determine if duloxetine 60mg given perioperatively, is safe and effective at reducing postoperative opioid consumption and reported pain following elective orthopedic surgery. Method CINAHL, Medline, Cochrane Central Registry for Clinical Trials, Google Scholar, and Clinicaltrials.gov were searched using a predetermined search strategy from inception to January 15, 2019. Covidence.org was used to screen, select, and extract data by two independent reviewers. Individual study bias was assessed using the Cochrane Risk of Bias tool. Opioid consumption data were converted to oral morphine milligram equivalents (MME) and exported to RevMan where meta-analysis was conducted using a DerSimonian and Laird random effects model. Results Six randomized-controlled trials were included in the literature review of postoperative pain and adverse effects. Five studies were utilized for the meta-analysis of postoperative opioid consumption; totaling 314 patients. Postoperative pain analysis showed variable statistical significance with overall lower pain scores with duloxetine. Adverse effects included an increase in insomnia with duloxetine but lower rates of nausea and vomiting. Meta-analysis revealed statistically significant [mean difference (95% CI)] lower total opioid use with duloxetine postoperatively at 24h [- 31.9 MME (- 54.22 to - 9.6), p = 0.005], 48h [- 30.90 MME (- 59.66 to - 2.15), p = 0.04] and overall [- 31.68 MME (- 46.62 to - 16.74), p < 0.0001]. Conclusion These results suggest that adding perioperative administration duloxetine 60mg to a multimodal analgesia regimen within the orthopedic surgery setting significantly lowers total postoperative opioid consumption and reduces pain without significant adverse effects.

The Efficacy and Adverse Effects of Favipiravir on COVID-19 Patients: A&amp;nbsp;Systematic Review and Meta-Analysis of Published Clinical Trials and Observational Studies

Background: The burden of COVID-19 on healthcare systems worldwide requires an efficient treatment option. Favipiravir, a nucleoside analog, is a potential COVID-19 treatment. Therefore, this study aimed to evaluate the efficacy and adverse events of favipiravir in COVID-19 patients.Method: In our systematic review and meta-analysis, we performed searches of PubMed, Scopus, Embase, Web of Science, the Cochrane Library, Google Scholar, European PMC, Virtual Health Library, mRCT, ClinicalTrials.gov, SIGLE, the WHO COVID-19 research article database, Covid-evidence.org, and the iSearch COVID-19 Portfolio with the latest update on February 8 th , 2021. All types of studies in which favipiravir was used on COVID-19 patients were included and extracted by two independent authors. All studies underwent systematic review, data from controlled trials underwent meta-analysis. Our protocol was registered on PROSPERO as CRD42020206305.Findings: 145 studies (15 randomized controlled trials (RCTs), one non-RCT, 21 observational studies, two case series, and 106 case reports) were included. In comparison to standard of care (SOC), favipiravir showed a higher rate of viral clearance at day 5 (RR=1·49, p=0·03), defervescence at day 3 (RR=1·91, pInterpretation: Adding favipiravir to the standard of care provides better outcomes for COVID-19 patients. Pregnant and lactating women as well as a history of hyperuricemia or gouty arthritis should be noticed when using favipiravir. Using favipiravir could reduce the rate of nausea and vomiting for some patients.Registration Details: Registered on PROSPERO as CRD42020206305.Funding Information: Grant Asian clinical trial network construction project (Number JP20LK0201001J0001) by Japan Agency for Medical Research and Development (AMED).Declaration of Interests: We declare no competing interests.

EFFICACY OF ANESTHETIC COCKTAIL WOUND INSTILLATION FOR POSTOPERATIVE ANALGESIA FOLLOWING POSTERIOR SPINAL SURGERY

Background: Posterior spinal surgery is a common procedure in orthopedic practices that causes severe pain after surgery. Proper postoperative pain controls not only benefit early mobilization and initiation of physiotherapy but they also play important roles in reducing morbidity and mortality.&#x0D; Objective: This prospective, double-blinded, randomized controlled study investigated the efficacy of anesthetic cocktail wound instillation for postoperative analgesia following posterior spinal surgery.&#x0D; Methods: After posterior spinal surgery, 54 patients were randomized to instill 20 mL of normal saline (Group N) or anesthetic cocktail consisting bupivacaine, ketorolac and morphine (Group A) in the wound after securing hemostasis and leaving a contact time of 60 seconds. After a dwell time of 60 seconds, the wound layers were closed without mopping or suctioning. All patients in both groups received patient-controlled analgesia using morphine for 24 hours post surgery, followed by standard analgesia. The analgesia consumption (morphine), visual analog scale (VAS) at specific hours after the operation, and time for first demand of analgesia were recorded. Morphine-related side effects were also monitored.&#x0D; Results: The patients in group A consumed significantly less morphine at 4, 8, 12 and 16 hours after the surgery (p=0.048, 0.007, 0.005 and 0.026, respectively). In addition, they had lower VAS over the first 24 hours (p&lt;0.05) and longer median duration of first demand of analgesia (p=0.013). Morphinerelated side effects were also lower in group A (p=0.024). Conclusion: The simple technique of wound instillation with anesthetic cocktail significantly reduced postoperative requirements of morphine and improved pain control with lower rates of nausea and vomiting over the first postoperative day after posterior spinal surgery.

S2077 Balloon-Induced Gastric Outlet Obstruction

INTRODUCTION: Intragastric balloons (IGB) function as an artificial bezoar and delay gastric emptying by increasing wall strain and contributing to feelings of satiety. 25% of patients who undergo IGB placement will experience complications, with nausea and vomiting as the most common (8.6%), and obstruction within the digestive tract as a much rarer cause (0.8%). Here we report gastric outlet obstruction (GOO) as a rare complication of IGBs. CASE DESCRIPTION/METHODS: A 67-year-old female with hypothyroidism and major depressive disorder presented with 5 days of profound nausea and vomiting. Prior to admission, the patient underwent gastric balloon placement and after the procedure, the patient was unable to tolerate both solid food and liquids. The patient denied any abdominal pain and her last bowel movement was 2 days prior to admission. Lab work revealed severe hypokalemia (2.6 mmol/L) and hypomagnesemia (< 0.2 mg/dL). CT imaging of the abdomen and pelvis revealed an 11-cm gastric balloon within the distal stomach without signs of bowel obstruction (image 1). The patient immediately underwent esophagogastroduodenoscopy, which revealed the IGB obstructing a large food bolus (image 2). The IGB was subsequently deflated and removed. The patient was discharged home after electrolyte repletion and diet toleration. DISCUSSION: Traditionally, the IGB is a silicone balloon filled with saline that is adjustable in size, safe, and significantly effective in weight loss. Almost half of all gastric balloons are removed early. Indications for gastric balloon removal include severe symptom intolerance, balloon deflation, digestive tract obstruction, and concern for gastric ulcer/perforation. Its risks for serious complications should not be overlooked, as digestive tract obstruction from displaced or deflated balloons may lead to gastric perforation or even death. There is debate regarding the preference for type of fluid or air medium in IGBs. The recently implemented air-filled IGB has also been effective in significant weight loss reduction with lower rates of nausea, vomiting and bowel obstruction compared to fluid-filled IGBs. In this case, this was the second fluid-filled IGB the patient had placed and removed. A different type of IGB could have been considered. With new emerging technology in both endoscopic technique and balloon durability, new studies will need to examine the continued safety and efficacy of gastric balloons in obesity management.Figure 1.: Image 1. CT chest with oral contrast, depicting large saline filled gastric balloon.Figure 2.: Image 2. Left: IGB obstructing antrum from prior EGD; Right: IGB obstructing antrum with food bolus.

Evaluation of Efficacy of Free Opioid Anesthesia for Laparoscopic Cholecystectomy: A Prospective, Randomized Double-blinded Study

Objectives: To evaluate efficacy and side effects of free opioid anesthesia for laparoscopic cholecystectomy. Methods: A prospective study was performed on 94 patients undergoing laparoscopic cholecystectomy in Military Hospital 103 from May 2018 to February 2019. These patients were randomly allocated into two groups: patients in FOA (free - opioid anesthesia) group were administered lidocaine (2 mg/kg before induction and 1.5 mg/kg/h for maintenance), magnesium (30 mg/kg before induction and 1.5 g infusion for maintenance) combined with Intravenous (IV) injection of ketamine (0.5 mg/kg), and ketorolac (30 mg); while patients in OA group (opioid anesthesia) were provided with IV fentanyl (5 mcg/kg for induction and 1.5 mcg/kg every 30 minutes for maintenance of anesthesia). Both groups received total intravenous anesthesia by propofol. The depth of anesthesia was monitored by the entropy module during surgery. Neuromuscular blockade was reversed by sugammadex 2 mg/kg at the end of surgery. The postoperative analgesia was delivered using IV fentanyl for 48 to 72 hours. Visual Analog Scale (VAS) score was measured 10 mins, 20 mins, 1 hour, 2 hours and 3 hours after surgery. Results: All patients had an excellent quality of anesthesia with RE (Respond Entropy), SE (State Entropy) always under 60 from induction to abdominal closure without intraoperative awareness and postoperative recall of the operation; 100% of the patients were extubated immediately after surgery. In the first three postoperative hours fentanyl consumption in Group FOA was significantly lower than in Group OA (31.91 ± 3.98 mcg versus 34.47 ± 7.17 mcg, p=0,035). In the OA group, the rate of intraoperative hypotension was higher compared to its counterpart. Despite the higher risk of hypersalivation, group FOA had a significantly lower incidence of nausea and vomiting. Conclusion: Free opioid anesthesia provided adequate sedation and amnesia and may be an alternative approach to opioid anesthesia for laparoscopic cholecystectomy. Patients under free opioid anesthesia experienced a lower incidence of intraoperative hypotension, lower rate of nausea, vomiting and lower demand for analgesia in the early postoperative period (0 - 3 h) compared to those receiving opioid anesthesia.

Intravenous Dexamethasone Injection Reduces Pain From 12 to 21 Hours After Total Knee Arthroplasty: A Double-Blind, Randomized, Placebo-Controlled Trial

BackgroundPain after total knee arthroplasty (TKA) affects postoperative recovery and patient satisfaction. The analgesic benefits of corticosteroids have not been well studied. We, therefore, investigated the analgesic effects of intravenous (IV) dexamethasone (DEX) in patients undergoing a TKA. MethodsThis was a randomized, double-blind, placebo-controlled trial of 0.15 mg/kg of IV DEX vs saline placebo in unilateral TKA. Fifty patients/arm were recruited. Primary outcomes were pain level, determined by a visual analog scale, and the amount of morphine consumption (mg) ≤48 hours post-TKA. Secondary outcomes were rates of nausea and vomiting, C-reactive protein concentrations, and functional outcomes. ResultsThe DEX group had a significantly lower mean visual analog scale score both at rest and during motion at 12, 15, 18, and 21 hours (P < .05). At 21 hours, the mean difference (Δ) in pain at rest was −11 points (95% confidence interval [CI], −21 to −2 points; P = .02) while the mean difference in pain during motion was −15 points (95% CI, −25 to −5 points; P = .004). The DEX group also had lower rates of nausea and vomiting: 29/50 (58%) vs 42/50 (84%) (P = .008) and lower mean C-reactive protein level: 89 vs 167, Δ = −78 mg/L (95% CI, −100 to −58 mg/L, P < .0001). There were no significant differences in mean morphine consumption by 48 hours, modified Western Ontario and McMaster University Osteoarthritis Index scores, and range of motion of the knee at 3-month follow-up (P > .05). ConclusionIV DEX relieves postoperative pain between 12 to 21 hours after TKA and may be a useful adjunct for controlling pain in patients undergoing TKA.

1032-P: Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed-Ratio Combination vs. Insulin Glargine in Japanese Patients with T2DM

The fixed ratio combination of insulin glargine/lixisenatide (iGlarLixi) has been shown in a Western population to improve glycemic control in a convenient single daily injection. This open-label trial assessed the efficacy and safety of 26-week treatment of iGlarLixi and insulin glargine (iGlar) in Japanese patients with T2DM inadequately controlled on basal insulin and oral antidiabetic drugs. After a 12-week run-in with metformin and iGlar, patients were randomized to iGlarLixi (n=255) or iGlar (n=257). Starting from a mean baseline (BL) HbA1c of 8.25%, the decrease in the iGlarLixi group was significantly greater than in the iGlar group (LS mean difference [SE]: -0.74% [0.063], p&amp;lt;0.0001) (Figure). Significantly more patients reached the HbA1c target of &amp;lt;7% at Week 26 with iGlarLixi than with iGlar (51.8% vs. 16.0%, p&amp;lt;0.0001). Change in body weight from BL to Week 26 was -0.51 kg with iGlarLixi and +0.55 kg with iGlar (p&amp;lt;0.0001). Both treatments were well tolerated. Documented symptomatic hypoglycemia (≤70 mg/dL) was similar in the two treatment groups (iGlarLixi: 18.8%, iGlar: 16.7%). Nausea was reported in 16.9% (iGlarLixi) and 0.8% (iGlar). In conclusion, iGlarLixi showed superior glycemic control to iGlar, with a beneficial effect on body weight, no additional risk of hypoglycemia, and lower rate of nausea than reported with lixisenatide. Disclosure H. Kaneto: Research Support; Self; Astellas Pharma Inc., AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Company, Limited, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Nippon Boehringer Ingelheim Co ., Ltd., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. Speaker's Bureau; Self; Astellas Pharma Inc., AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Company, Limited, Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Kowa Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, MSD K.K., Nippon Boehringer Ingelheim Co ., Ltd., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Ono Pharmaceutical Co., Ltd., Pfizer Japan Inc., Sanofi K.K., Sumitomo Dainippon Pharma Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. A. Takami: Employee; Self; Sanofi K.K. R. Spranger: Employee; Self; Sanofi-Aventis Deutschland GmbH. A. Amano: Employee; Self; Sanofi K.K. D. Watanabe: Employee; Self; Sanofi K.K. E. Niemoeller: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. Funding Sanofi K.K.

Efficacy and tolerability of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes mellitus.

Glucagon-like peptide-1 (GLP-1) has been evaluated for use in the treatment of type 2 diabetes mellitus (T2DM) due to its role in glucose regulation. Four GLP-1 receptor agonists (RAs) are currently indicated for T2DM in the USA. Exenatide and liraglutide are short-acting and require twice-daily and daily dosing, respectively. Two longer acting agents, exenatide long-acting release (LAR) and albiglutide, were formulated to allow for once-weekly dosing. All four GLP-1 RAs have demonstrated reductions in hemoglobin A1c, fasting blood glucose, and body weight both as monotherapy and in combination with first- and second-line diabetes agents including metformin, sulfonylureas, thiazolidinediones, and insulin. Greater glycemic control was seen with liraglutide compared with the other GLP-1 treatment options; however, the two long-acting agents were superior to exenatide twice daily. All agents were well tolerated with most adverse events being mild or moderate in nature. The most common adverse event was transient nausea which typically resolved 4-8 weeks after treatment initiation. Long-acting agents had lower rates of nausea but an increased incidence of injection site reactions. Trials have suggested GLP-1 RAs may improve cardiovascular risk factors including blood pressure, lipid parameters and inflammatory markers. Future trials are needed to confirm the clinical outcomes of these agents. Overall, GLP-1 RAs will provide benefit for patients with T2DM intolerable to or not reaching glycemic goals with first-line agents, especially in patients in need of weight loss.

Pregnancy complications in the mothers who delivered boys with isolated hypospadias – a population-based case–control study

Objective: The evaluation of pregnancy complications of mothers who delivered boys with isolated hypospadias (IHS) to estimate their roles in the higher rate of low birthweight and preterm birth in cases with IHS.Methods: The incidence of prospectively and medically recorded pregnancy complications in the prenatal maternity logbook was compared in the mothers of 3038 cases with IHS and their 4981 matched controls, in addition, 24 814 population male controls without any defects in the Hungarian Case–Control Surveillance of Congenital Abnormalities, 1980–1996.Results: The well-known higher rate of preterm birth and mainly of low birthweight was confirmed in cases with IHS. The incidence of preeclampsia/eclampsia (OR with 95% CI: 1.92, 1.62–2.27) and gestational diabetes (1.94, 1.34–2.81) was higher, while severe nausea and vomiting in pregnancy (0.77, 0.66–0.88) showed a lower incidence in the mothers of cases.Conclusion: The higher rate of preeclampsia/eclampsia may have a role in the intrauterine growth restriction of fetuses affected with IHS while the lower rate of nausea and vomiting in pregnancy may associate with the higher risk of preterm birth.

Pregabalin Calms Restless Legs by Unknown Mechanism

Oral pregabalin (Lyrica) significantly improved symptoms of moderate to severe restless leg syndrome (RLS), compared with both placebo and pramipexole, in an industry-sponsored, international randomized trial. Also, pregabalin was associated with significantly less worsening of symptoms than was pramipexole, Richard P. Allen, PhD, of the department of neurology at Johns Hopkins University, Baltimore, and his associates reported in the New England Journal of Medicine. Pregabalin also was associated with lower rates of nausea, vomiting, and headache than pramipexole, but patients taking pregabalin had higher rates of suicidal ideation, dizziness, somnolence, and weight gain – “factors that may limit its long-term use,” the investigators said. Dopaminergic drugs such as pramipexole are known to be associated with augmentation in which symptoms intensify and may involve more parts of the body and start earlier in the day than before treatment, so researchers have been searching for an alternative medication. Pregabalin is a nondopaminergic agent with analgesic and anticonvulsant activity. Dr. Allen and his colleagues assessed both agents in a study involving 719 adults with moderate to severe primary RLS who were treated and followed at 102 medical centers in the United States and Europe. In the double-blind trial sponsored by Pfizer, these patients were randomly assigned to receive 0.25 mg pramipexole, 0.5 mg pramipexole, 300 mg pregabalin, or matching placebo capsules every day for 12 weeks. At that time, all patients receiving placebo were randomly reassigned to one of the three active treatments for the remainder (40 weeks) of the 1-year study. At 12 weeks, patients who received pregabalin showed significantly greater improvement in International RLS (IRLS) Study Group Rating Scale scores than did those who received placebo. Patients who received pregabalin also reported greater improvement in waking after sleep onset, quality of sleep, number of nightly awakenings, and total sleep time. These measures also were significantly better for patients treated with 0.5 mg pramipexole when compared with placebo-treated patients, but not for those taking 0.25 mg pramipexole. In a noninferiority assessment, pregabalin outperformed both doses of pramipexole on reduction in IRLS score at both 12 weeks and 52 weeks. The finding that pregabalin is effective for RLS even though it has no direct effect on dopaminergic systems calls into question the rationale for dopaminergic therapies. Dopaminergic treatments have been predicated on the assumption that RLS results primarily from dopamine abnormalities, Dr. Allen and his associates noted (N. Engl. J. Med. 2014;370:621–631). A total of 50 serious adverse events occurred in 37 patients: 16 events in the pregabalin group, 22 events in the lower-dose pramipexole group, and 12 events in the higher-dose pramipexole group. This included 11 cases of suicidal ideation: 6 in the pregabalin group, 3 in the lower-dose pramipexole group, and 2 in the higher-dose pramipexole group. Editor's NoteLooks like Lyrica will be seeking Food and Drug Administration approval for restless leg syndrome, and it looks like it works reasonably well, with a different set of side effects from those seen with dopaminergic agents.It's a bit puzzling that a GABA-ergic drug would work for this condition. But benzodiazepines are often used with decent utility for restless legs. And if pregabalin works, maybe the much less expensive, noncontrolled, neurochemically similar drug gabapentin might be worth a try. That would be off label, of course, but for someone suffering with severe restless leg syndrome and limited response or intolerance of usual drugs, I'd consider it.— Karl Steinberg, MD, CMDEditor in Chief Looks like Lyrica will be seeking Food and Drug Administration approval for restless leg syndrome, and it looks like it works reasonably well, with a different set of side effects from those seen with dopaminergic agents. It's a bit puzzling that a GABA-ergic drug would work for this condition. But benzodiazepines are often used with decent utility for restless legs. And if pregabalin works, maybe the much less expensive, noncontrolled, neurochemically similar drug gabapentin might be worth a try. That would be off label, of course, but for someone suffering with severe restless leg syndrome and limited response or intolerance of usual drugs, I'd consider it. — Karl Steinberg, MD, CMD Editor in Chief

The Efficacy of Periarticular Multimodal Drug Injection for Postoperative Pain Management in Total Knee or Hip Arthroplasty

The efficacy of periarticular multimodal drug injection (PMDI) to reduce pain after total knee or hip arthroplasty (TKA or THA) still remains controversial. Our study aimed at evaluating the efficacy of PMDI after TKA or THA. A fully recursive literature search was conducted to identify relevant randomized controlled trials. Ultimately, 21 studies were included in the analysis. Pooled results showed that the PMDI group had better pain relief, less opioid consumption, larger range of motion, and lower rates of nausea and vomiting than the placebo group. No significant difference was seen in regard to the length of hospital stay between the two groups. In conclusion, PMDI should be recommended for the pain management after TKA or THA.

The effect of transdermal scopolamine plus intravenous dexamethasone for the prevention of postoperative nausea and vomiting in patients with epidural PCA after major orthopedic surgery

BackgroundPostoperative nausea and vomiting (PONV) is common complication of Patient-Controlled Analgesia (PCA) after surgery. The authors sought to determine whether a transdermal scopolamine (TDS) patch in combination with IV dexamethasone is more effective than IV dexamethasone alone or IV dexamethasone plus IV ramosetron for reducing PONV in patients receiving epidural PCA after major orthopedic surgery.Methods120 patients that received epidural PCA with hydromorphone and ropivacaine after major orthopedic surgery under spinal anesthesia were allocated to 3 groups: Group D (n = 40) received IV dexamethasone 8 mg, Group DR (n = 40) received IV dexamethasone 8 mg plus IV ramosetron 0.3 mg, Group DS (n = 40) received IV dexamethasone 8 mg plus a TDS patch (Group DS, n = 40). Nausea and vomiting incidences, VAS for nausea, the use of additional antiemetics, and adverse effects (a dry mouth, blurred vision, drowsiness) during the first 24 hours postoperatively were subjected to analysis.ResultsThe DS Group had a significantly higher rate of complete remission of PONV than the D and DR groups (82.5% vs 47.5%, and 50.0%, respectively), and had lower rates of nausea (17.5% vs 55.0%, and 50.0%), and vomiting (10.0% vs 50.0%, and 25.0%), and required less antiemetics (5.0% vs 35.0%, 22.5%) than group D and Group DR during the first 24 hours after surgery. Furthermore, no inter-group differences were observed with respect to adverse effects in the three groups.ConclusionsThe prophylactic use of a TDS patch plus dexamethasone was found to be a more effective means of preventing PONV in patients that received epidural PCA after major orthopedic surgery than dexamethasone alone or dexamethasone plus ramosetron without adversely affecting side effects.

Fast Track Program in Patients Undergoing Radical Cystectomy: Results in 362 Consecutive Patients

This article outlines our current perioperative management of patients undergoing cystectomy and urinary diversion using advancements in perioperative care to allow for early institution of an oral diet and early hospital discharge. Three hundred sixty-two consecutive patients underwent radical cystectomy and urinary diversion with curative intent (2001 through 2008). Each underwent a perioperative care plan ("fast track" program). Throughout our experience, evidence-based modifications to this program were instituted. We analyzed the impact of these modifications and report the outcomes with the most recent 100 patients in whom no additional modification has been used. Mean age of patients is 66.3 years, with 44% of the patients older than age 70 years and 12% older than age 80 years. We found no detrimental effects to immediate removal of the orogastric tube at the end of the procedure, but found a beneficial effect of empiric metoclopramide use, with lower rates of nausea and vomiting. Perioperative antibiotic coverage has been reduced to 24 hours as per American Urological Association guidelines. Gum-chewing has also been shown to be of benefit with regard to a more rapid recovery of bowel function. Use of nonnarcotic analgesics (eg, ketrolac) has also been central in the pathway. Finally, early institution of an oral diet has been an original and central component to our fast track program. Successful application of a fast track program has been applied to our patients undergoing radical cystectomy and urinary diversion, with the potential to use evidence-based modifications to reduce morbidity and improve recovery.