Prospective Double-blind Randomized Trial Research Articles

Vitis Vinifera Seed Extract Versus Micronized Purified Flavonoid Fraction for Patients with Chronic Venous Disease: A Randomized Noninferiority Trial

Venoactive drugs (VADs) based on Vitis vinifera extract are widely used in Korea. However, studies on the clinical effects and head-to-head comparisons with other groups of VADs are limited. This trial aimed to evaluate whether Vitis vinifera seed extract was noninferior to the micronized purified flavonoid fraction (MPFF) in relieving venous symptoms and improving quality of life in patients with chronic venous disease. In this double-blind prospective randomized trial, patients from 13 hospitals, who were diagnosed with venous incompetence by duplex ultrasound and classified as clinical class 1, 2, or 3 in the Clinical, Etiological, Anatomical, and Pathophysiological classifications were enrolled. The primary outcome was the change in the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score at 8weeks from baseline. Secondary outcomes included changes in the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score at 4 and 8weeks from baseline. Moreover, the change in leg circumferences was measured at 8weeks and compared to baseline. In total, 303 patients were enrolled and randomly assigned to receive either Vitis vinifera seed extract (n=154) or MPFF (n=149). The CIVIQ-20 scores at 8weeks were significantly reduced compared to those at baseline in both groups. No significant intergroup difference in the change of CIVIQ-20 at 8weeks from baseline was observed (-8.31±14.63 vs. -10.35±14.38, P=0.29, 95% confidence interval -1.65 to 5.72). The lower limit of the 95% confidence interval was within the predefined noninferiority margin of 6.9. Furthermore, the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score scores significantly decreased at 4 and 8weeks after randomization compared with baseline in both groups. No significant differences were observed in the reduction of each score between groups. The calf circumference measured at 8weeks was significantly reduced compared to that at baseline in patients receiving Vitis vinifera seed extract. Vitis vinifera seed extract was noninferior to MPFF in relieving venous symptoms and improving the quality of life in patients with chronic venous disease.

Levobupivacaine Consumption in Automated Intermittent Bolus in Ultrasound Guided Subparaneural Sciatic Nerve Catheters: A Prospective Double-Blind Randomized Trial

PurposeContinuous sciatic nerve blocks have proven benefits for postoperative analgesia after foot surgery. However, the optimal mode of administration remains a point of debate. Ultrasound guided subparaneural injection accelerates onset time and increases duration after a single shot sciatic nerve block. This double blind prospective randomized trial compares the 48-hour local anesthetic (LA) dose consumption of an automated intermittent bolus technique to a continuous infusion regimen in a subparaneural sciatic nerve catheter after hallux valgus surgery.Patients and MethodsPatients scheduled for hallux valgus surgery were randomized to receive either a continuous infusion of levobupivacaine 0.125% at 5mL/h (group A) or an intermittent automated bolus of 9.8 mL every 2 hours with a background of 0.1 mL/h (group B), both with a PCA bolus of 6 mL and lockout of 30 minutes. The 48 hour LA consumption, PCA boluses, Numeric Rating Scale (NRS), satisfaction and return of normal sensation were recorded.ResultsSixteen patients were excluded because of protocol violation or technical problems and 42 patients remained for analysis. The 48 hour ropivacaine consumption was higher in group A (293 ±60 mL) than group B (257±33 mL). The median and highest NRS scores and patient satisfaction were not statistically different between groups. Normal sensation returned after 75 ± 22 hours (group A) and 70 ± 17 hours (group B).ConclusionProgrammed bolus administration in subparaneural sciatic nerve catheters reduces LA consumption 48 hours after surgery with equal analgesia and patient satisfaction. Return of sensation is variable and can last more than 75 hours.

Comparison of quadratus lumborum block and caudal block for postoperative analgesia in pediatric patients undergoing inguinal hernia repair and orchiopexy surgeries: a randomized controlled trial

Background and objectivesCaudal epidural anesthesia is a widely used popular technique for postoperative analgesia but it has potential side effects and duration of analgesia is short. Quadratus lumborum block (QLB)...

Comparative Study of Two Nebulized Preparations of Salbutamol in Children

Aim: Salbutamol is the main treatment for asthma attacks. It can be given via inhaler, nebulizer or oral route. Nebulization is mainly used at emergency departments. The aim of our study is to compare the clinical efficacy of two nebulized salbutamol preparations Ventolin® GSK and Asthalin® CIPLA. Methods: We conducted a prospective double blind randomized trial between April and December 2017 in which 30 children with asthma were included. Children were assigned randomly to receive nebulized Asthalin® or Ventolin®, with 15 patients included in each study arm. For each patient, oxygen saturation, presence of wheezing, retractions and thoraco-abdominal asynchrony, before and after Salbutamol nebulization were recorded. The effect of each treatment dose on oxygen saturation and respiratory rate after stratification of the initial population was analyzed. Results: Ventolin® increased oxygen saturation by 1.87% and decreased respiratory rate by 10.87 breaths per minute, while Asthalin® improved oxygen saturation by 1.8% and decreased respiratory rate by 9.53 breaths per minute. However, the difference was not significant as it was not significant for respiratory symptoms improvement and need for oxygenation and hospitalization rates. Conclusion: There is no significant difference between Ventolin® and Asthalin® when given via nebulization. Both treatments improved oxygen saturation, respiratory rate and respiratory symptoms similarly.

Minimum twelve-year follow-up of fixed- vs mobile-bearing total knee arthroplasty: Double blinded randomized trial

BackgroundTotal knee arthroplasty (TKA) with fixed-bearing (FB) implants have demonstrated impressive functional results and survival rates. Meanwhile, rotating-platform (RP) constructs have biomechanically shown to reduce polyethylene wear, lower the risk of component loosening, and better replicate anatomic knee motion. There is growing question of the clinical impact these design changes have long-term.Questions/purposes: The aim of this double-blinded prospective randomized trial was to compare function and implant survival in patients who received either FB or RP press-fit condylar Sigma (PFC Sigma, DePuy, Warsaw, IN) total knee replacements at a minimum follow-up of twelve years. Patients and methodsPatient reported outcome measures used included the functional Knee Society Score, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores, Medical Outcomes Short Form-36 (SF-36) score, and satisfaction assessment on a four-point Likert scale. The data was collected from times preoperative, two-years, and final encounter (mean 13.95 years). A total of 28 RP and 19 FB knees (58.8%) were analyzed at the final follow-up. ResultsAmong all patients, KSS and WOMAC scores statistically improved from pre-op to 2-year, while KSS statistically worsened from 2-year to final follow-up. The RP group averaged better follow-up scores in all assessments at the final follow-up with exception of overall satisfaction. There was no statistically significant difference in the functional Knee Society Score, Short Form-36, WOMAC scores, patient satisfaction or implant survival between the two groups at any measured period. ConclusionsThe use of a fixed-bearing or rotating-platform design does not convey significant superiority in terms of function or implant longevity at a minimum twelve years after total knee arthroplasty. Level of evidenceLevel I, Experimental study, randomized controlled trial (RCT).

Effect of different doses of ketamine with low-dose rocuronium on intubation conditions in children: prospective randomized double blind trial.

The effect of ketamine on intubation condition, when used as an induction agent with low-dose rocuronium, is unknown. This study aimed to compare the effects of three doses of ketamine used with 0.3 mg/kg rocuronium and 1 µg/kg fentanyl on intubation conditions in children undergoing short elective surgery. The study was performed as a prospective, randomized double-blind clinical trial. A total of 60 children aged 2 to 12 years, who were scheduled for inguinal herniorrhaphy under general anesthesia, were randomly allocated into three groups on the basis of ketamine dose: 1 mg/kg (Group K1, n = 20), 1.5 mg/kg (Group K1.5, n = 20), and 2 mg/kg (Group K2, n = 20). The primary outcome was the intubation condition. Other assessments included hemodynamic data, recovery profile, adverse events in the postanesthetic care unit (PACU) and use of fentanyl as a rescue analgesic in the PACU were also assessed. The occurrence of a clinically acceptable intubation condition increased with the use of an increased dose (≥ 1.5 mg/kg) (K1/K1.5/K2: 30%/65%/65%; p=0.038, for trends p=0.028). Hemodynamic data, recovery profile and adverse events in PACU showed no difference among groups. Fentanyl dose used in the PACU was higher in K1 than K2 and the number of patients requiring rescue analgesics in the PACU decreased in accordance with the dose of ketamine (K1/K1.5/K2: 30%/15%/0%; p=.031, for trends p=0.013). Different intubation conditions were observed on the basis of ketamine dose used in conjunction with 0.3 mg/kg rocuronium and fentanyl 1 µg/kg. Ketamine dose ≥ 1.5 mg/kg with low-dose rocuronium should be used to improve intubation conditions in pediatrics.

Supraclavicular Brachial Plexus Block: Comparison of Varying Doses of Butorphanol Combined with Levobupivacaine - A Double-Blind Prospective Randomized Trial.

Background:The ideal dose of butorphanol for brachial plexus block is not well known.Aims:This study was carried out to evaluate 1 mg and 2 mg of butorphanol added to 0.375% levobupivacaine, with regard to the duration of analgesia. Our study also sought to assess the onset and duration of sensorimotor blockade, hemodynamic effects, sedation, and adverse effects.Settings and Design:This study was a prospective, randomized, double-blinded, and comparative study.Methods:Eighty adult patients of either sex undergoing upper limb surgeries under supraclavicular brachial plexus block were randomly allocated into two groups. Group LB1 received 29 ml of 0.375% levobupivacaine plus 1 mg of butorphanol diluted in 1 ml of normal saline. Group LB2 received 29 ml of 0.375% levobupivacaine plus 2 mg of butorphanol diluted in 1 ml of normal saline. The onset and duration of sensorimotor blockade, level of sedation, duration of analgesia, and adverse effects were assessed.Statistical Analysis:The data were analyzed with Student's t-test and Chi-square test.Results:The onset of sensory (P = 0.032) and motor block (P = 0.026) was earlier in Group LB2 than in Group LB1. The duration of analgesia was significantly prolonged in Group LB2 (643.55 ± 131.6 vs. 511.73 ± 128.6 min; P = 0.001). The incidence of sedation was observed in more number of patients in Group LB2 (P = 0.01). Furthermore, the incidence of nausea, vomiting, and pruritus were observed in more number of patients in Group LB2 (P < 0.05).Conclusion:Higher dose of butorphanol in brachial plexus block hastens the onset and prolongs the duration of sensorimotor blockade and analgesia but is associated with a higher incidence of sedation which requires intense monitoring.

A double blinded prospective randomized trial comparing the effect of anatomic versus non-anatomic resection on hepatocellular carcinoma recurrence

BackgroundThe aim of this study was to determine the effect of anatomic resection (AR) versus non-anatomic resection (NAR) on recurrence rates in patients with hepatocellular carcinoma (HCC). MethodsEligible patients were randomized to AR or NAR from January 2006 to July 2007 at a single center. The primary outcome was the 2-year recurrence-free survival (RFS). Secondary outcomes were postoperative complications, time to first recurrence, 1-, 3-, and 5-year RFS, and overall survival (OS). ResultsFifty-three (51%) and 52 (50%) patients underwent NAR and AR, respectively. A larger proportion of patients achieved margins ≥20 mm in the AR group (52% vs. 30%; P = 0.023). Complications (blood loss, transfusion requirement, and hospital stay) were similar between the two groups. Median follow-up was 33 (range, 2–77) months. Incidence of local recurrence at 2 years was 30% and 59% in the AR and NAR groups, respectively. Median time to first local recurrence in the AR group was significantly longer than in the NAR group (53 vs. 10 months, P = 0.010). There was no difference in overall RFS between the two groups (P = 0.290). DiscussionAR decreased the 2-year local recurrence rate and increased the time to first local recurrence compared to NAR in patients with HCC.

BRACHIAL PLEXUS BLOCK

Objectives: The aim of our study is to find out the efficacy of dexamethasone(8mg) on prolonging the duration of motor and sensory blockade as used in brachial plexusblock required for forearm and hand surgeries. Study Design: Prospective randomized doubleblind trial. Period: April 2013 to May 2014, for a period of 14 months. Setting: Tertiary carehospital in Karachi Pakistan. Method: The study population consisted of 42 patients belongingto ASA classification, grades I and II, who underwent elective surgical procedures involving theforearm and hand. The patients were divided in to three groups, group A consisted of patientswho were given 2% of prilocaine at 5mg per kg of body weight, group B consisted of patientswho were given 2% of prilocaine with dexamethasone (8mg as 2ml) at group C consisted ofpatients who were given 0.5% of levobupivacaine at 1.5mg per kg of body weight. The timeduration and onset of sensory and motor blockade was duly noted for all the three groups.Data was analyzed using SPSS version 20. Results: The time of onset of motor and sensoryblock in group A and B, were very similar, there was a difference of longer duration was dulynoted in group C, which was statistically significant (p&lt;0.001). In terms of the duration of block,a statistically significant difference was found when compared in the three groups (p&lt;0.001).The duration of sensory and motor blockade was longer in Group C when compared to theother two groups, and they were found to be longer in group B when compared with group A(p&lt;0.001). Side effects were not found in the study population due to small number of patientsevaluated. Conclusion: According to our study the addition of dexamethasone to the prilocaineused in hand and forearm surgeries resulted in increased duration of the sensory and motorblockade achieved. While levobupivacaine was found to be a very potent anesthetic when usedlocally for post op analgesia requirements and during long procedures.

English

Objectives: The aim of our study is to find out the efficacy of dexamethasone(8mg) on prolonging the duration of motor and sensory blockade as used in brachial plexusblock required for forearm and hand surgeries. Study Design: Prospective randomized doubleblind trial. Period: April 2013 to May 2014, for a period of 14 months. Setting: Tertiary carehospital in Karachi Pakistan. Method: The study population consisted of 42 patients belongingto ASA classification, grades I and II, who underwent elective surgical procedures involving theforearm and hand. The patients were divided in to three groups, group A consisted of patientswho were given 2% of prilocaine at 5mg per kg of body weight, group B consisted of patientswho were given 2% of prilocaine with dexamethasone (8mg as 2ml) at group C consisted ofpatients who were given 0.5% of levobupivacaine at 1.5mg per kg of body weight. The timeduration and onset of sensory and motor blockade was duly noted for all the three groups.Data was analyzed using SPSS version 20. Results: The time of onset of motor and sensoryblock in group A and B, were very similar, there was a difference of longer duration was dulynoted in group C, which was statistically significant (p&lt;0.001). In terms of the duration of block,a statistically significant difference was found when compared in the three groups (p&lt;0.001).The duration of sensory and motor blockade was longer in Group C when compared to theother two groups, and they were found to be longer in group B when compared with group A(p&lt;0.001). Side effects were not found in the study population due to small number of patientsevaluated. Conclusion: According to our study the addition of dexamethasone to the prilocaineused in hand and forearm surgeries resulted in increased duration of the sensory and motorblockade achieved. While levobupivacaine was found to be a very potent anesthetic when usedlocally for post op analgesia requirements and during long procedures.

SPINAL ANESTHESIA

Objective: The purpose of the study is to compare and assess the sensoryand motor block along with the associated hemodynamic changes that occur in the patientpopulation operated for a lower segment cesarean section (LSCS), when they are given 0.5%hyperbaric bupivacaine versus 0.5% isobaric bupivacaine as used for spinal anesthesia.Study Design: Prospective double blind randomized trial. Period: 6 months duration fromApril 2014 to September 2014. Setting: A tertiary care hospital in the city of Karachi, Pakistan.Method: The study population consisted of 60 patients belonging to the ASA 1 and ASA 2category, who underwent a lower segment cesarean section, and comparative analysis ofthe efficacy and associated hemodynamic changes of hyperbaric with isobaric bupivacaine.The patient population was segmented into two groups both groups containing 30 patients,group A receiving hyperbaric bupivacaine 0.5% as 2.5ml ( 12.5mg dose ) and the secondgroup designated as, group B receiving isobaric bupivacaine 0.5% as 2.5ml ( 12.5mg dose)intrathecally. The resultant sensory and motor blockade was determined using pin prick andbromage scale respectively. Results: There was a significant difference found among the twogroups under study, when compared at 3min interval regarding the sensory blockade. The levelof T6 block was reached in 33.33% (n=10) patients belonging to group A and 56.66% (n= 17)patients in group B. It was observed that there was no significant change among the two groupsat 5min interval regarding sensory and motor blockade respectively. The immediate sensoryblockade with isobaric bupivacaine in group B produced greater decrease in the systolic andmean arterial blood pressure when contrasted with hyperbaric bupivacaine in group A at 5mininterval, but after time interval of 45min there was no statistically significant change observed.Conclusions: According to our study the effects of isobaric bupivacaine were more significantlypredictable; hence have a higher efficacy, when contrasted against hyperbaric bupivacainein lower section cesarean section spinal anesthesia. Quick sensory blockade with isobaricbupivacaine was associated with more decrease in blood pressures when contrasted with thehyperbaric bupivacaine, but this result is not statistically significant.

English

Objective: The purpose of the study is to compare and assess the sensory and motor block along with the associated hemodynamic changes that occur in the patient population operated for a lower segment cesarean section (LSCS), when they are given 0.5% hyperbaric bupivacaine versus 0.5% isobaric bupivacaine as used for spinal anesthesia. Study Design: Prospective double blind randomized trial. Period: 6 months duration from April 2014 to September 2014. Setting: A tertiary care hospital in the city of Karachi, Pakistan. Method: The study population consisted of 60 patients belonging to the ASA 1 and ASA 2 category, who underwent a lower segment cesarean section, and comparative analysis of the efficacy and associated hemodynamic changes of hyperbaric with isobaric bupivacaine. The patient population was segmented into two groups both groups containing 30 patients, group A receiving hyperbaric bupivacaine 0.5% as 2.5ml ( 12.5mg dose ) and the second group designated as, group B receiving isobaric bupivacaine 0.5% as 2.5ml ( 12.5mg dose) intrathecally. The resultant sensory and motor blockade was determined using pin prick and bromage scale respectively. Results: There was a significant difference found among the two groups under study, when compared at 3min interval regarding the sensory blockade. The level of T6 block was reached in 33.33% (n=10) patients belonging to group A and 56.66% (n= 17) patients in group B. It was observed that there was no significant change among the two groups at 5min interval regarding sensory and motor blockade respectively. The immediate sensory blockade with isobaric bupivacaine in group B produced greater decrease in the systolic and mean arterial blood pressure when contrasted with hyperbaric bupivacaine in group A at 5min interval, but after time interval of 45min there was no statistically significant change observed. Conclusions: According to our study the effects of isobaric bupivacaine were more significantly predictable; hence have a higher efficacy, when contrasted against hyperbaric bupivacaine in lower section cesarean section spinal anesthesia. Quick sensory blockade with isobaric bupivacaine was associated with more decrease in blood pressures when contrasted with the hyperbaric bupivacaine, but this result is not statistically significant.

Maternal Vitamin D Supplementation for Breastfeeding Infants: Will it Work?

Infants fortunate enough to be exclusively breastfeeding are at risk for insufficient vitamin D intake, and if vitamin D deficient, are at risk for rickets. Despite an unequivocal recommendation by the American Academy of Pediatrics to provide 400 IU of oral vitamin D daily beginning in the first days postpartum, national studies conducted both before and after publication of these recommendations estimate that only 1 in 5 breastfed US infants achieves this goal.1–3 Both provider and parent compliance play a role when recommendations are not followed.4–5To address this issue, an elegant prospective randomized double-blind trial by Hollis and colleagues6 explores an option that has been “food for thought” and study for several years: supplementation of maternal vitamin D as a substitute for infant supplementation. Their trial carefully addressed potentially confounding variables, including latitude, season, maternal skin pigmentation, BMI, and diet. The study was challenged by attrition because of discontinued exclusive breastfeeding, with just 148 of the 389 who were randomized (38%) able to complete the trial, raising another important public health issue. But when the curtain falls, we learn that 6400 IU of daily maternal vitamin D3 for 6 months successfully supports maternal vitamin D status, and the authors’ previous work documents that this produces sufficient vitamin D levels for breastfeeding infants.6–7The results are valuable, but questions remain. Who will prescribe this medication for mothers, and who will pay for it? And does this strategy shift rather than resolve the compliance burden of vitamin D supplementation?American Academy of Pediatrics guidelines endorse care by pediatricians through age 26 years, but obviously many mothers are older than this. Although practicable for family practice and combined internal medicine and pediatrics physicians, not all internists or obstetricians will wish to collaborate and treat the mother per this recommendation. Although vitamin D can be purchased over the counter, advising mothers on their medications and supplements is not clearly a wise professional strategy. The study arm providing 2400 IU of vitamin D was discontinued by the Data Safety Monitoring Committee because receipt of this dose “…showed a significant, independent association with infant deficiency…” at visit 4, so uncertain or partial dosing is risky.6 And vitamin D is not free. Lower socioeconomic status and eligibility for WIC (the Special Supplemental Nutrition Program for Women, Infants, and Children) are risk factors for breastfeeding noninitiation and discontinuation: in an ugly turn of events, could recommending maternal supplementation create another (perceived) barrier to breastfeeding in this subpopulation?8 Medication compliance is complex and not described by demographic factors alone, but adults with lower health literacy taking long-term medications that do not make them “feel better” (read maternal vitamin D supplementation) are at meaningful risk for therapeutic noncompliance.9Maternal supplementation has the added potential benefit of improving maternal health, and may be preferable and economically acceptable for many families. This approach, however, should inspire us to brainstorm new strategies for infant supplementation, especially tactics that level the playing field and overcome health disparities associated with breastfeeding. Interestingly, our colleagues to the north have reports of success, with 74% to 80% of parents reporting giving vitamin D supplements, so there is good reason to persevere.10–11Additional potential strategies include beginning infant vitamin D3 in the newborn nursery, partnered with other effective public health programs in the newborn order set, such as hepatitis B vaccination, newborn screening by blood spot, and hearing testing. Certainly it is counterintuitive to insist that infants receiving the “perfect food” must take a dietary supplement, an issue Hollis and colleagues6 address at length. But in the first days of life, even infants receiving formula alone do not consume sufficient volumes to meet their vitamin D goals; the safety of early universal prescribing, with a brief educational component, is difficult to dispute.Strategies to overcome financial barriers are needed: Medicaid health maintenance organizations do not issue infant insurance cards for several weeks or the plan may request “prior authorization,” and the cost of multivitamin drops may tip the budget for low- or middle-income families. Free medication alone, however, is not a panacea: a free prescription program in Montreal failed to improve odds of obtaining vitamin D for the infant, with reduced prescription uptake and an increased prevalence of rickets cases over the 4-year study period.12 WIC serves >50% of infants in the United States, and WIC dieticians are currently an untapped resource for educating, and supporting vitamin D supplementation.Other possible stratagems include public health messaging, addition of infant vitamin D to ambulatory electronic medical record order sets, and augmented trainee education. Finally, we need a way to track rates of vitamin D deficiency rickets, rather than just relying on case reports, and a National Registry could facilitate this.13–14 Excellent studies, like the work of Hollis et al,6 generate as many questions as answers, and ultimately energize us to tackle tough clinical questions.

Efficacy of a laparoscopically delivered transversus abdominis plane block technique during elective laparoscopic cholecystectomy; a prospective double blind randomized trial

Efficacy of a laparoscopically delivered transversus abdominis plane block technique during elective laparoscopic cholecystectomy; a prospective double blind randomized trial

Adding different doses of intrathecal magnesium sulfate for spinal anesthesia in the cesarean section: A prospective double blind randomized trial

Background:There is uncertainty as to whether addition of magnesium sulfate to spinal local anesthetics improves quality and duration of block in the caesarean section. In this randomized double blind clinical trial study, we investigated the effect of adding different doses of intrathecal magnesium sulfate to bupivacaine in the caesarean section.Materials and Methods:After institutional approval and obtaining informed patient consent, 132 ASA physical status I-II women undergoing elective cesarean section with spinal anesthesia were randomized to four groups: 1 – 2.5 cc Bupivacaine 0.5%+ 0.2 cc normal saline (group C) 2 – 2.5 cc Bupivacaine 0.5%+ 0.1 cc normal saline+ 0.1 cc magnesium sulfate 50% (group M50) 3– 2.5 cc Bupivacaine 0.5%+ 0.05 cc normal saline+ 0.15 cc magnesium sulfate 50% (group M75) 4– 2.5 cc Bupivacaine 0.5%+ 0.2 cc magnesium sulfate 50% (group M100). Patients and staff involved in data collections were unaware of the patient group assignment. We recorded the following: onset and duration of block, time to complete motor block recovery, and analgesic requirement.Results:Magnesium sulfate caused a delay in the onset of both sensory and motor blockade. The duration of sensory and motor block were longer in M75 and M100 groups than group C (P < 0.001). Recovery time was shorter in group C (P < 0.001) and analgesic requirement was more in group C than others (P < 0.001).Conclusions:In patients undergoing the caesarean section under hyperbaric bupivacaine spinal anesthesia, the addition of 50, 75, or 100 mg magnesium sulfate provides safe and effective anesthesia, but 75 mg of this drug was enough to lead a significant delay in the onset of both sensory and motor blockade, and prolonged the duration of sensory and motor blockade, without increasing major side effects.

Prophylactic antibiotic use in elective inguinal hernioplasty in a trauma center

In this double-blind prospective randomized trial, our objective was to investigate the effect of antibiotic prophylaxis in patients undergoing elective inguinal hernia surgery with mesh repair in a large-volume tertiary referral trauma center. Eligible patients were assigned randomly to either an antibiotic prophylaxis group or a control group. Patients in the prophylaxis group were given 1 g cefazolin by IV bolus injection whereas the placebo control group received an equal volume of sterile saline preoperatively. A Lichtenstein repair was done in all cases. The patients were examined for surgical site infection (SSI) and other postoperative local complications before discharge, and reexamined 3, 5, 7, and 30 days after discharge. Groups were well matched for age, sex, coexisting diseases, ASA scores, type of hernia, type of anesthesia, duration of surgery. Incidence of infection was 7% in the control group (7/100) and 5% in the prophylaxis group (5/100) (P = 0.38). All the infections were superficial and responded well to drainage and proper antibiotic therapy. All other postoperative complications were similar in the two groups. In our settings antibiotic prophylaxis has no significant effect on the incidence of SSI in elective repair of inguinal hernias with mesh. The most effective way to reduce the incidence of infection in prosthetic repair may be a specific center for treatment of abdominal wall hernias.

Mini-Midvastus vs Standard Medial Parapatellar Approach: A Prospective, Randomized, Double-Blinded Study in Patients Undergoing Bilateral Total Knee Arthroplasty

The purpose of this study was to determine whether the mini-midvastus approach to total knee arthroplasty (TKA) results in differences in quadriceps muscle strength as well as previously cited advantages in a double blind prospective randomized trial. Twenty-seven patients (54 TKAs) scheduled for bilateral TKA were randomized to undergo mini-midvastus approach on one knee and standard approach on the other. Incision lengths were the same. Postoperative strength was determined by isokinetic and isometric peak torque testing. Range of motion, pain Visual analog scale, side-preference, and gait analysis were assessed preoperatively and postoperatively. The only significant difference in strength testing was increased isokinetic and isometric extension torque at 3 weeks postoperatively for the mini-midvastus approach. No differences between the mini-midvastus and standard approach were observed for stride length, stance time, pain Visual analog scale, or knee range of motion. The mini-midvastus approach has limited benefit compared to the standard approach for TKA.

Montelukast does not prevent reactive airway disease in young children hospitalized for RSV bronchiolitis

To evaluate the long-term effect of montelukast on symptoms of cough and wheeze following RSV bronchiolitis. Fifty eight patients (aged < or = 24 months) hospitalized with a first episode of RSV bronchiolitis were enrolled in this double blind prospective randomized trial comparing montelukast (n = 31) vs placebo (n = 27). During the 3-month treatment period, there were no statistical significant differences between the two groups for symptom-free days and nights (48.5 [interquartile range 33.0.0-66.0] for montelukast vs 57.0 [29.0-71.0] for placebo p = 0.415) nor disease-free days and nights (44.5 days [26.0-54.0] vs 53.0 [22.3-71.0]; p = 0.266). During the 1 year follow-up, there were 41 exacerbations in the montelukast group vs 54 exacerbations in the placebo group (p = 0.57). Time to first exacerbation was not different. Number of unscheduled visits and need to start inhaled steroids were comparable in the two groups. Treatment with montelukast after hospital admission for RSV bronchiolitis in children younger than 2 years of age did not reduce symptoms of cough and wheeze. We cannot exclude that a subgroup of children may, however, benefit from this treatment.

The effect of azithromycin and Chlamydophilia pneumonia infection on expansion of small abdominal aortic aneurysms - A prospective randomized double-blind trial

The aim of the study was to evaluate the effect of azithromycin on the expansion rate of small abdominal aortic aneurysms (AAAs), and to determine whether or not a correlation exists between serological markers for Chlamydophilia pneumonia (Cpn) infection and AAA expansion. Nine vascular centers were included and 259 patients were invited to participate. Ten patients declined and 2 patients had chronic kidney failure, leaving a total of 247 patients. Inclusion criteria were: AAA 35-49 mm and age <80 years. Patients were randomized to receive either azithromycin (Azithromax, Pfizer Inc, New York, NY) 600 mg once daily for 3 days and then 600 mg once weekly for 15 weeks, or placebo in identical tablets. The ultrasound scans were performed in a standardized way within a month before inclusion and every 6 months for a minimum follow-up time of 18 months. Cpn serology was analyzed in blood samples taken at inclusion and 6 months later. Serum was analyzed for Cpn IgA and IgG antibodies by microimmunofluorescence (MIF). Computed tomography (CT) scans were done in 66 patients at inclusion and at 1 year for volume calculations. Thirty-four patients were excluded, ie, could not be followed for 18 months, 20 in the placebo group and 16 in the active treatment group. A total of 211 patients had at least two measurements and all were analyzed in an intention-to-treat analysis. Detectable IgA against Cpn was found in 115 patients and detectable IgG against Cpn in 160 patients. No statistically significant differences were found between the groups regarding median expansion rate measured by ultrasound scan (0.22 cm/year, interquartile range [IQR]: 0.09 to 0.34 in the placebo group vs 0.22, IQR: 0.12 to 0.36 in the treatment group, P = .85). Volume calculation did not change that outcome (10.4 cm(3)/year in the placebo group vs 15.9 cm(3)/year in the treatment group, P = .61). No correlation was found between serological markers for Cpn infection and the expansion rate. Patients taking statins in combination with acetylsalicylic acid (ASA) had significantly reduced expansion rate compared to patients who did not take statins or ASA, 0.14 cm/year vs 0.27 cm/year, P < .001. Azithromycin did not have any effect on AAA expansion. No correlation was found between serological markers for Cpn and AAA expansion, indicating no clinical relevance for Cpn testing in AAA surveillance. However, a significant reduction in AAA expansion rate was found in patients treated with a combination of ASA and statins.

Postoperative nausea and vomiting in cardiac surgery

Editor, Recently published editorials [1,2] described recurrent interest in droperidol for postoperative nausea and vomiting (PONV) prophylaxis and treatment. In 2004, we presented the results of a double-blind prospective randomized trial examining the incidence of PONV in cardiac surgery, its relation to cardiopulmonary bypass (CPB) duration, and the efficacy of different antiemetic drugs for PONV prevention [3]. In a prospective fashion, we studied 142 adult patients with left ventricle ejection fraction of more than 45% undergoing coronary artery bypass grafting (CABG) with CPB. The induction and maintenance of anaesthesia were standardized. Postoperative analgesia was provided with morphine intravenously (i.v.) as needed. The patients had no previous history of PONV; all risk factors for PONV were similar among groups. The patients were randomly allocated to receive droperidol 1.25 mg (group I, n = 27), thiethylperazine 6.5 mg (group II, n = 33), ondansetron 4 mg (group III, n = 34), or placebo (group IV, n = 48) 30 min before the end of the procedure. The duration of CPB and the number of PONV episodes during the first 12 h in the ICU were recorded. Metoclopramide was chosen as a rescue medication to treat PONV episodes. The results were evaluated by correlation coefficient (r) and χ2 test (P). The duration of CPB in individual study groups (mean ± SD: I, 76 ± 16; II, 74 ± 13, III, 74 ± 17; and IV, 73 ± 18 min, respectively) had no influence on the incidence of PONV in each group (r = −0.080), and all the groups together (r = −0.081). The incidence of PONV after pharmacological prevention (18.5, 18.0, 18.0%) was insignificantly (P > 0.05) lower than that in placebo group (27.1%). The number of patients in groups I, II, and III with more than one PONV episode (3.7, 9.0, 2.9%) was not reduced significantly (P > 0.05) compared with placebo (10.4%). The incidence of PONV in CABG patients was comparable to other types of surgery and did not correlate with the CPB duration. The pharmacological prophylaxis did not significantly decrease incidence and the number of PONV episodes. Our results suggest that droperidol was as effective as other antiemetic agents that do not carry the black box warning. Droperidol appeared as well tolerated and as effective as other tested agents in our study. However, it could be easily substituted by other agents, which are associated with less cardiovascular/neurologic/psychiatric adverse effects. Although the rationale to keep the black box on droperidol may be subject to ongoing debate, it seems that there are other options available that serve high-risk cardiac population as well as droperidol.