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Single-blind Study (single-blind + study)
Selected AbstractsCoblation versus Unipolar Electrocautery Tonsillectomy: A Prospective, Randomized, Single-Blind Study in Adult Patients,THE LARYNGOSCOPE, Issue 8 2006J Pieter Noordzij MD Abstract Objectives: To determine if the coblation tonsillectomy (subcapsular dissection) results in less postoperative pain, equivalent intraoperative blood loss, equivalent postoperative hemorrhage rates, and faster healing compared with tonsillectomy was performed using unipolar electrocautery in adult patients. Study Design: The authors conducted a prospective clinical trial. Methods: Forty-eight patients underwent tonsillectomy and were randomly assigned to have one tonsil removed with coblation and the other with unipolar electrocautery. Outcome measures included time to remove each tonsil, intraoperative blood loss, patient-reported pain, postoperative hemorrhage, and amount of healing 2 weeks after surgery. Results: Mean time to remove a single tonsil with coblation and electrocautery was 8.22 minutes and 6.33 minutes, respectively (P = .011). Mean intraoperative blood loss for each technique was less than 10 mL. Postoperative pain was significantly less with coblation as compared with electrocautery: 18.6% less painful during the first week of recovery. Seventy percent of blinded patients identified the coblation side as less painful during the overall 14-day convalescent period. Postoperative hemorrhage rates (2.1% for coblation and 6.2% for electrocautery) were not significantly different. No difference in tonsillar fossa healing was observed between the two techniques 2 weeks after surgery. During nine of the 48 surgeries, wires on the tip of the coblation handpiece experienced thinning to the point of discontinuity while removing a single tonsil. Conclusions: Coblation subcapsular tonsillectomy was less painful than electrocautery tonsillectomy in this 48-patient group. On average, intraoperative blood loss was less than 10 mL for both techniques. Postoperative hemorrhage rates and the degree of tonsillar fossa healing were similar between the two techniques. The coblation handpiece experienced degradation of vital wires in 18% of cases necessitating the use of a second, new handpiece. [source] Short-Term Effects of Right Ventricular Pacing on Cardiorespiratory Function in Patients With a Biventricular PacemakerCONGESTIVE HEART FAILURE, Issue 6 2008Stefan Toggweiler MD The intention of this study was to evaluate the short-term effect of right ventricular (RV) pacing on cardiorespiratory function in patients with a biventricular pacemaker. A group of 26 patients with a biventricular pacemaker was enrolled in this cross-over, single-blind study. All patients underwent spiroergometry and electrocardiography in RV and biventricular pacing mode. Peak work capacity (102±32 W and 107±34 W for RV and biventricular pacing mode, respectively; P<.01) and peak oxygen consumption (21.4±6.7 mL/min/kg and 22.6±7.0 mL/min/kg for RV and biventricular pacing mode, respectively; P<.01) were significantly lower in the RV pacing mode. Heart rate at rest was significantly higher with active RV pacing. Short-term RV pacing in patients with a biventricular pacemaker resulted in a higher heart rate at rest, a lower peak work capacity, and a lower peak oxygen consumption compared with that in the biventricular pacing mode. [source] Sparing the larynx during gynecological laparoscopy: a randomized trial comparing the LMA SupremeÔ and the ETTACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 2 2010W. ABDI Background: We designed a prospective randomized single-blind study to compare efficiency and post-operative upper airway morbidity when the laryngeal mask airway (LMA) SupremeÔ is used as an alternative to the endotracheal tube (ETT). Methods: One hundred and thirty-eight elective pelvic laparoscopic ASA I,II female patients were assigned to receive either the LMA Supreme® or the ETT for airway management. Balanced anesthesia and ventilation techniques were standardized to control end-tidal CO2 and BIS value in the range 4.5,5 kPa and 40,50, respectively, and to maintain adequate hemodynamic stability. A single surgeon blinded to the airway management technique performed all surgical procedures. The ventilation efficiency of each airway was evaluated. Anesthesia- and surgery-related times were calculated and anesthesia details were recorded. Post-operative pain and pharyngolaryngeal morbidity were measured in a blind fashion using a numerical rating scale (NRS) (0,100). Results: Surgery duration was similar in both groups. Airway management duration was shorter with the LMA Supreme®. Post-operative pharyngolaryngeal morbidity incidence and all symptoms' intensity were significantly increased after ETT as compared with LMA Supreme® anesthesia. At the end of the PACU stage, the incidence and mean NRS of post-operative hoarseness were reduced when LMA Supreme® was used as an alternative to the ETT (16% vs. 47%; P<0.01 and 9 vs. 19, P<0.01, respectively). Conclusion: We demonstrated that choosing an LMA Supreme® was an efficient pharyngolaryngeal morbidity-sparing strategy. Moreover, we showed that the LMA Supreme® and the ETT were equally effective airways for a routine gynecological laparoscopy procedure. [source] Effect of a controlled-release chlorhexidine chip on clinical and microbiological parameters of periodontal syndromeJOURNAL OF CLINICAL PERIODONTOLOGY, Issue 10 2002Daniela C. Grisi Abstract Aim: The aim of this study was to evaluate the effectiveness of a controlled-released chlorhexidine chip (CHX) as adjunctive therapy to scaling and root planing (SRP) in the treatment of chronic periodontitis. Material and methods: Twenty patients with at least four sites with probing depth ,,5 mm and bleeding on probing were selected. This randomized single-blind study was carried out in parallel design. The control group received SRP alone, while the test group received SRP plus CHX chip. The clinical parameters, Plaque Index (PlI), Papillary Bleeding Score (PBS), Bleeding on Probing (BOP), Gingival Recession (GR), Probing Depth (PD) and Relative Attachment Level (RAL), and the microbiological parameter BANA test were recorded at baseline and after 3, 6 and 9 months. Results: Both groups presented significant improvements in all parameters analyzed over the study period. There were no statistically significant differences between the two groups for any parameter analyzed after 9 months, except for BOP, which was significantly reduced in the control group. The mean reductions on PD and RAL were 2.4 mm and 1.0 mm for the control group and 2.2 mm and 0.6 mm for the test group, respectively. Conclusion: The CHX chip did not provide any clinical or microbiological benefit beyond that achieved with conventional scaling and root planning, after a 9-month period. Zusammenfassung Wirkung eines Chlorhexidin-Chips mit kontrollierter Wirkstoff-Freisetzung auf klinische und mikrobiologische Parameter parodontaler Erkrankungen Zielsetzung: Das Ziel der vorliegenden Studie war die Evaluierung der Wirksamkeit eines Chlorhexidin-Chips mit kontrollierter Wirkstoff-Freisetzung (CHX) als Adjunktivtherapie zu Zahnsteinentfernung (Scaling) und Wurzelglätten (Root planing) bei der Behandlung einer chronischen Parodontitis. Material und Methodik: Zur Teilnahme an der Studie wurden zwanzig Patienten mit mindestens vier Stellen mit einer Sondiertiefe von ,5 mm und Blutung bei der Sondierung ausgewählt. Diese randomisierte einfach-blinde Studie wurde mit Parallelgruppenaufbau durchgeführt. Die Kontrollgruppe erhielt ausschliesslich SRP, die Testgruppe dagegen erhielt SRP plus den CHX-Chip. Zu Baseline und nach 3, 6 und 9 Monaten wurden die klinischen Parameter Plaque-Index (PlI), Papillarblutungs-Score (PBS), Blutung bei Sondierung (BOP), Gingivaretraktion (GR), Sondiertiefe (PD), Relatives Attachmentniveau (RAL) und die mikrobiologischen Parameter (BANA-Test) verzeichnet. Ergebnisse: Beide Gruppen zeigten signifikante Verbesserungen aller analysierten Parameter über den Studienzeitraum. Nach 9 Monaten konnten mit Ausnahme von BOP, was in der Kontrollgruppe eine signifikante Reduktion zeigte, keine statistisch signifikanten Unterschiede zwischen den beiden Gruppen für die untersuchten Parameter festgestellt werden. Die durchschnittlichen Reduktionen bei PD und RAL waren 2,4 mm und 1,0 mm in der Kontrollgruppe und 2,2 mm bzw. 0,6 mm in der Testgruppe. Schlussfolgerung: Nach einer 9-monatigen Behandlungszeit konnten mit dem CHX-Chip zusätzlich zu dem durch konventionelles Scaling und Wurzelglätten erzielten klinischen und mikrobiologischen Nutzen keine weiteren Vorteile erzielt werden. Résumé Influence d'une capsule de chlorhexidine à libération contrôlée sur les paramètres cliniques et microbiologiques de la maladie parodontale But: Le but de cette étude était d'évaluer l'efficacité d'une capsule de chlorhexidine (CHX) à libération contrôlée comme thérapie complémentaire au détartrage et au surfaçage radiculaire (scaling and root planing, SRP) dans le traitement de la parodontite chronique. Matériaux et méthodes: Vingt patients avec au moins quatre sites présentant une profondeur au sondage ,5 mm et un saignement au sondage ont été sélectionnés. Cette étude randomisée en simple aveugle a été conduite en parallèle. Le groupe contrôle a uniquement bénéficié de SRP, tandis que le groupe test a reçu SRP plus une capsule CHX. Les paramètres cliniques, l'indice de plaque (plaque index, PlI), l'indice de saignement papillaire (papillary bleeding score, PBS), la saignement au sondage (bleeding on probing, BOP), la récession gingivale (gingival recession, GR), la profondeur au sondage (probing depth, PD), le niveau d'attache relatif (relative attachment level, RAL) et les paramètres microbiologiques (test BANA) ont été enregistrés à la base puis après 3, 6 et 9 mois. ésultats: Les deux groupes présentaient une amélioration significative de tous les paramètres analysés au cours de la période d'étude. Entre les deux groupes, il n'y avait de différence statistiquement significative pour aucun des paramètres analysés au bout de 9 mois, sauf pour le BOP qui était considérablement réduit dans le groupe contrôle. Les baisses moyennes de PD et RAL valaient respectivement 2,4 mm et 1,0 mm pour le groupe contrôle, et 2,2 mm et 0,6 mm pour le groupe test. Conclusion: A l'issue d'une période de 9 mois, la capsule CHX n'a apporté aucun bénéfice clinique ou microbiologique supérieur à celui obtenu par détartrage et surfaçage radiculaire conventionnels. [source] Clinical trial: 2-L polyethylene glycol-based lavage solutions for colonoscopy preparation , a randomized, single-blind study of two formulationsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2010L. B. Cohen Aliment Pharmacol Ther 2010; 32: 637,644 Summary Background, The 2-L polyethylene glycol (PEG) lavage solutions provide efficacy similar to that of standard 4-L PEG formulations in spite of the reduced volume. The comparative efficacy and tolerability of two formulations of 2-L PEG solution remain unknown. Aims, To assess the efficacy, safety and tolerability of PEG + Bis compared with PEG + Asc, and to study the effect of bowel cleansing quality on adenoma detection rates. Methods, Patients were randomized to receive either 2-L PEG with ascorbic acid (PEG + Asc) or 2-L PEG plus bisacodyl 10 mg (PEG + Bis). The primary endpoint was overall colon cleansing score, assessed by blinded investigators using a validated four-point scale. Secondary endpoints included adenoma detection rate, patient tolerability and compliance and adverse events. Results, Fifty-two patients received PEG + Asc and 55 patients received PEG + Bis. Overall colon cleansing scores (±s.d.) were 1.40 ± 0.69 and 1.75 ± 0.70 (P < 0.003) in the PEG + Asc and PEG + Bis groups, respectively. Excellent and good ratings were recorded in 69% and 23% receiving PEG + Asc compared to 38% and 51% (P = 0.01) of patients receiving PEG + Bis. More adenomas were detected in colonoscopies performed with PEG + Asc (39%) than in those performed with PEG + Bis (20%) (P = 0.04). Patient tolerability and safety were similar with both preparations. Conclusion, The use of PEG + Asc resulted in better colon cleansing and higher adenoma detection rates compared with PEG + Bis. [source] Clinical trial: the efficacy and safety of routine bowel cleansing agents for elective colonoscopy in persons with spinal cord injury , a randomized prospective single-blind studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11-12 2009H. R. ANCHA Summary Background, As difficulty with evacuation is a common occurrence in individuals with spinal cord injury, preparation prior to colonoscopy may be suboptimal and, perhaps, more hazardous. Aim, To assess the safety and efficacy of bowel cleansing regimens in persons with spinal cord injury. Methods, Randomized, prospective, single blind study comparing polyethylene glycol (PEG), oral sodium phosphosoda (OSPS) and combination of both for colonic preparation prior to colonoscopy in subjects with spinal cord injury. Results, Thirty six subjects with eGFR ,60 mL/min/1.73 m2 were randomized to PEG or OSPS or PEG+OSPS. Regardless of bowel preparation employed, >73% of subjects had unacceptable colonic cleansing. No subject in the OSPS preparation group demonstrated a decrease in eGFR or an increase in serum creatinine concentration from the baseline. OSPS and PEG+OSPS preparations caused a transient change in serum potassium, phosphate and calcium concentrations, but no change in electrolytes was noted in the PEG group. Conclusions, Neither OSPS alone, PEG alone nor their combination was sufficient to prepare adequately the bowel for colonoscopy in most patients with spinal cord injury. However, administration of OSPS and/or PEG appears to be safe in the spinal cord injury population, provided adequate hydration is provided. [source] Efficacy of a protein kinase C inhibitor (tamoxifen) in the treatment of acute mania: a pilot studyBIPOLAR DISORDERS, Issue 6 2007Carlos A Zarate Jr Objectives:, Considerable preclinical biochemical and behavioral data suggest that protein kinase C inhibition would bring about antimanic effects. Notably, the structurally highly dissimilar antimanic agents lithium and valproate, when administered in therapeutically relevant paradigms, attenuate protein kinase C inhibition function. There is currently only one relatively selective protein kinase C inhibitor that crosses the blood,brain barrier available for human use , tamoxifen. Our group recently conducted a single-blind study with tamoxifen in acute mania and found that it significantly decreased manic symptoms within a short period of time (3,7 days). In this study, we investigated whether antimanic effects can be achieved with a protein kinase C inhibitor in subjects with mania. Methods:, In a double-blind, placebo-controlled study, 16 subjects with bipolar disorder, manic or mixed, with or without psychotic features, were randomly assigned to receive tamoxifen (20,140 mg/day; n = 8) or placebo (n = 8) for three weeks. Primary efficacy was assessed by the Young Mania Rating Scale. Results:, Subjects on tamoxifen showed significant improvement in mania compared to placebo as early as five days, an effect that remained significant throughout the three-week trial. The effect size for the drug difference was very large (d = 1.08, 95% confidence interval 0.45,1.71) after three weeks (p = 0.001). At study endpoint, response rates were 63% for tamoxifen and 13% for placebo (p = 0.12). Conclusions:, Antimanic effects resulted from a protein kinase C inhibitor; onset occurred within five days. Large, controlled studies with selective protein kinase C inhibitors in acute mania are warranted. [source] | ||||||||||